Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science's Top EmployerInsmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma , Best Workplaces in New York , PEOPLE Companies That Care, Best Workplaces for Women , Best Workplaces for Millennials , and Best Medium Workplaces lists. Overview The Associate Director, Clinical Programming provides technical leadership and ensures adequate clinical programming support for assigned projects. Assists the Head of Programming to ensure successful implementation of programming strategies and efficient execution of analyses for assigned clinical projects. Collaborates with cross-functional team members within Biometrics, Clinical Operations, Regulatory, and Clinical Development, as well as with external vendors. Oversees contractors and coaches junior team members. Responsibilities Leads the clinical programming activities across a compound (or multiple compounds) and related oversight activities ensuring quality and timelinessSets tasks, prioritization, and resources within assigned compound(s)Provides program-level clinical programming leadership and support to clinical development teams Provides hands-on programming support to clinical programming activities, both internally and in response to regulatory agencies' requests for information as neededEnsures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs and Work InstructionsLeads process improvement initiativesProvides technical guidance to Insmed programmers, contractors, and vendors around project conventions, standards, practices, and specifications to ensure integrated computing solutionsProvides review and/or authors SOPs and/or Work Instructions related to clinical programming practicesContributes to the creation, maintenance, and validation of internal standards for programming tools, outputs, and macrosAssists the Head of Programming in assessing the programming environment to ensure programming and analysis efficiency, identifying ways to enhance the system where needed and acts as the subject matter expert on the systemQualifications:Bachelor's degree in statistics, biostatistics, mathematics, computer science, or equivalent required, advanced degree preferredMinimum of 8 years of clinical/statistical programming experience in a biotech, pharmaceutical, or CRO setting requiredExtensive knowledge of SAS software (i.e., Base, Stat, Graph components) and general computing techniques in addition to knowledge of R or other data visualization software packages (e.g., JReview)Significant knowledge of the drug development process, clinical trial methodology, and relevant regulatory requirements for drug approvalSignificant experience in clinical programming with an understanding of data managementExtensive knowledge of and experience with CDISC standards including SDTM and ADaM dataset specifications and define.xmlAble to adapt quickly to the changing needs of the organizationAbility to manage multiple projects in a fast-paced environmentAbility to problem-solveStrong project management skillsExcellent verbal and written communication skills; able to communicate proactively and effectively Salary Range $147,000 - $206,333 a year Compensation & Benefits At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location: Flexible approach to how we workHealth benefits and time-off plans Competitive compensation package, including bonus Equity Awards (Long-Term Incentives)Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here. Additional Information Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science's Top EmployerInsmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma , Best Workplaces in New York , PEOPLE Companies That Care, Best Workplaces for Women , Best Workplaces for Millennials , and Best Medium Workplaces lists. Overview The role will be responsible for the oversight of the strategic clinical development plans and successful conduct and execution of the TPIP clinical development program in pulmonary hypertension-related indications in mid-to-late stage development. In addition, this role will be responsible for strategic direction of clinical aspects of engagements with health authorities related to registration programs and filings. The individual will articulate the project goals, strategy and the underlying science and clinical need to internal and external audiences with clarity and credibility. Responsibilities Leads clinical development teams responsible for mid-to-late stage development of TPIP.Leads the Clinical Program Team (CPT) to effectively make decisions and handle conflict and change.Responsible for maintaining a high degree of CPT effectiveness through collaboration, influence, and, as necessary, coaching and mentoring of cross-functional team members.Representative to matrix Global Asset Team to ensure clinical program is represented and integrated into Global plans across functions.Build strategic and coordinated clinical development plans which are aligned with business objectives and are differentiated from competitor products.Leads and communicates the clinical development strategy at governance meetings, accountable for aligning with internal management and for communicating with external collaborators.Responsible for all clinical aspects of project strategy.Accountable for the delivery of projects partnering with other global development and related functions.Requirements and Qualifications:MD/DO equivalent with preference for Cardiology or Pulmonary formal training. Will consider industry experiences in Pulmonary or Cardiology in drug development.10+ years in biotech of pharma with most in a global clinical development role. Combination drug/device development experience is a plus.Experience with filing original NDA or BLA required with additional sNDA or sBLA experience strongly preferred. Experience with J-NDA a plus.Prefer experience in FDA advisory committee, or CHMP Scientific Advisory Group, or CHMP Oral Explanation experiences.Previous direct people management experience required.Experience working in matrix global development team, e.g. GPT, required. Salary Range $320,000 - $384,667 a year Compensation & Benefits At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location: Flexible approach to how we workHealth benefits and time-off plans Competitive compensation package, including bonus Equity Awards (Long-Term Incentives)Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here. Additional Information Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science's Top EmployerInsmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma , Best Workplaces in New York , PEOPLE Companies That Care, Best Workplaces for Women , Best Workplaces for Millennials , and Best Medium Workplaces lists. Overview Associate Director, Quality Compliance will play a key role in setting strategy and handling QA Global Regulatory Compliance activities for Insmed in both the US and across global sites. This individual will be responsible for Insmed Inspection Readiness, key compliance issues, and Internal Audits. This position will partner to ensure overall effectiveness of the Quality Organization within Insmed. The scope of this role includes commercial and development activities. Responsibilities Responsibilities:Partner with QA Leadership to ensure inspection readiness programs at global locations including on-going SME training, simulations, contact lists, introduction presentations and standard request readiness (complaint lists, deviation lists, SOP index, etc.), lessons learned. For US activities, act as the primary health authority inspection back room lead.Partner with QA leadership to communicate anticipated health authority inspections.Create, maintain/update and monitor the internal audit process including the annual schedule, reports and CAPA monitoring.Perform and/or coordinate all internal audits.Ensure Field Alert Process, product quality defects, and similar global events are assessed per the appropriate timelines. Ensure documentation and events are tracked to closure and reported on in Quality metrics.Mange global mock recall on an annual basis.Act as coordinator for any recallsCreate and maintain Standard Operating Procedures relating to areas of responsibility including Internal Audits, Health Authority Inspections, Field Alerts, Recalls etc.Partner with business collaborators and QA Leadership to ensure overall effectiveness of the Global Quality Organization.Lead Insmed Quality Intelligence team for regulation changesSupport key investigationsOther duties as assignedQualifications:BS degree in Chemistry, Engineering, Life Science or related field required.A minimum of 10 years of relevant Quality experience of increasing levels of responsibility required. Candidates with an advanced degree (MS) and a minimum of 8 years relevant experience will also be considered.Must be thoroughly knowledgeable on Global drug cGMP's, ISO 13485, and familiar with other Regulatory Requirements applicable to a medical device and combination product manufacturing operation.Auditing experience requiredDirect Global Quality experience preferred.Must have had Health Authority inspection experience.Must have direct experience with GMP compliance responsibilities, Inspection Readiness Programs, in pharmaceutical and/or medical device products.Experience with internal and external audits.ASQ CQA or similar Certification preferred.Must be able to partner and collaborate well cross functionally, at all levels.Must have excellent communication and influence skills (verbal and written).Should demonstrate the ability to manage projects and variable workloads.Acts in a highly organized manner with a strong attention to detail, clarity, accuracy and conciseness.At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:Flexible approach to how we workHealth benefits and time-off plansCompetitive compensation package, including bonusEquity Awards (Long-Term Incentives)Employee Stock Purchase Plan (ESPP) Salary Range $139,000 - $195,200 a year Compensation & Benefits At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:Flexible approach to how we workHealth benefits and time-off plansCompetitive compensation package, including bonus Equity Awards (Long-Term Incentives)Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here . Additional Information Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions
Consistently Ranked Science's Top Employer
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row.
A Certified Great Place to Work
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma , Best Workplaces in New York , PEOPLE Companies That Care, Best Workplaces for Women , Best Workplaces for Millennials , and Best Medium Workplaces lists.
Overview
Insmed, a leading biopharmaceutical company, is seeking an experienced and dynamic Human Resources professional for the role of Associate Director, Organizational Development. This high-impact position is crucial in fostering the development of our organizational capabilities and developing and deploying change management strategy, communications, and learning to support the execution of our business strategy. This role acts as a change agent and cultural architect across functions, working directly with business unit level leaders and their direct reports as well as Human Resources Business Partners (HRBPs) to build adaptive leadership, cross-functional collaboration, and change capability skills. The ideal candidate will have a strong HR background and experience in global transformation and development projects that have impacted organization culture and capabilities. This role is a hybrid position, offering a blend of in-office and remote work flexibility. Responsibilities
Responsibilities: Diagnose current organizational performance and culture, making recommendations for improvement and building organizational and functional change plans for HR initiatives driving significant impacts to Insmed's culture, leadership, and/or organizational development.Assess organizational needs and change readiness, championing large-scale change projects and targeted interventions in collaboration with the business and HR.Leverage HR expertise and change management frameworks like Prosci to collaborate with HR and project/functional leadership teams in designing, developing, implementing, and evaluating solutions that drive awareness, adoption, and reinforcement of key organizational transformation initiatives.Develop comprehensive transformation engagement strategies and content, including change management plans, internal communications, and learning/knowledge management programs. Ensure alignment of these transformation efforts with broader organizational strategies and Insmed's culture.In partnership with the Learning & Development team, create and implement learning that supports cultural transformation and org-wide capability and leadership development. This may include classroom/virtual instructor-led training, on-demand learning content, toolkits and/or quick reference guides. Utilize HR best practices to ensure these programs and content effectively drive behavior change.Facilitate stakeholder presentations, change management and team effectiveness workshops, and training sessions, leveraging OD expertise to drive engagement and learning.Leverage HR communications expertise, in partnership with Corporate Communications, to effectively engage employees, leaders, and key stakeholders in transformation and OD initiatives.Collaborate closely with HR Business Partners and manage key stakeholders to embed desired behaviors and mindset shifts, and build capability within Insmed's culture and workforce, leveraging HR principles and organizational development techniques.Apply HR analytics and metrics to measure change adoption and impact; adapt change management strategies and communications efforts based on data-driven decisions and HR best practices.Build a Transformation Center of Excellence (COE):Standardize Insmed's approach to managing change by creating a toolkit of HR-aligned templates, workshops, and other content for implementing transformation initiatives across the organization.Develop and deliver programs to upskill and equip Insmed employees and leaders with change management capabilities, integrating HR principles and best practices.Research and benchmarking innovative change and OD approaches and trends to ensure Insmed's transformation COE is continually evolvingManage and partner with identified change management or learning vendors, leveraging HR expertise to ensure alignment with Insmed's culture and transformation goals.Qualifications: Bachelor's degree in Human Resources, Business Administration, Organization Development, Communications or other related field required5-7+ years of related experience within HR, Organizational Change Management, Communications or Learning & Development required; prior experience in Pharma and/or Biotech a plus3-5 years of demonstrated experience and success supporting large-scale org change/transformation initiativesKnowledge of change management methodology and tools, human resources/OD practices, and strategic communication approaches.PROSCI Certification preferredProven ability to cultivate relationships, consult, influence and collaborate across all levels and functions in a global organization, leveraging HR and OD expertiseExcellent verbal, and written communication skills, including experience crafting HR communications for a Global, organization-wide audience.Demonstrated experience developing training programs and related learning assets, with experience using Articulate 360, Vyond, Adobe Creative Suite, Canva and/or other learning/content development toolsExperience facilitating workshops and delivering training to a multi-level, cross-functional audienceAbility to generate and implement creative ideas and innovate to enable impactful changeExceptional attention to detail and follow-through, with the ability to be flexible and adapt to changing HR and organizational needsAbility to maintain a high level of confidentiality.Highly proficient in Microsoft Office applications (Word, Excel, PowerPoint, Outlook). Salary Range
$139,000 - $195,200 a year Compensation & Benefits
At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:Flexible approach to how we workHealth benefits and time-off plans Competitive compensation package, including bonus Equity Awards (Long-Term Incentives)Employee Stock Purchase Plan (ESPP)
For more information on U.S. benefits click here.
Additional Information
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
. click apply for full job details
Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions
Consistently Ranked Science's Top Employer
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row.
A Certified Great Place to Work
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma , Best Workplaces in New York , PEOPLE Companies That Care, Best Workplaces for Women , Best Workplaces for Millennials , and Best Medium Workplaces lists.
Overview
The Vice President, Global Commercial Lead for a Pulmonary Hypertension-Interstitial Lung Disease/Pulmonary Arterial Hypertension product in development will be responsible for leading all aspects of all facets associated with the planning and potential US and global Marketing and commercialization of a product for PH-ILD/PAH. The Global Commercial Lead is the central point accountable for global brand strategy & overall development and success of the brand, upon approval. The Global Commercial Lead co-chairs the Global Asset Team ("GAT") along with the Global Clinical Development Lead. The Global Commercial Lead will be responsible for building and leading a U.S marketing team to deliver on global brand strategic imperatives through tactical execution, ensuring growth for in-line products and launch readiness for a product for PH-ILD/PAH. Responsibilities
Responsibilities: Be responsible for global marketing strategy and execution in collaboration with European and Japanese colleagues as well as the U.S. marketing strategy and executionDevelop global brand strategic imperatives to prepare and implement a robust launch plan, delivering on the global brand strategic imperativesWork closely with cross functional partners to ensure all aspects of US and global launch plan are developed in timely manner, gain leadership/executive team endorsement, develop and track KPIs, and successfully implement cross functionally, e.g. payer reimbursement, commercial effectiveness, operations, sales,Collaborate with colleagues where appropriate, considering the portfolio of Insmed respiratory assets. Build and lead US marketing team that is responsible for the development and execution of US launch planExplore and peruse relevant life-cycle opportunities for the product, e.g. new indications and/or formulations, where it makes business senseAlong with medical affairs, will understand medical thought leadership in the diseases, where the standard of care is going, the unmet needs that exist, and how Insmed can be best positioned to provide product solutions and support to the medical community to further patient care.Lead and drive a singular global brand strategy towards successful launch across indicationsImplement, through close collaboration with regions (currently anticipated Europe and Japan) and cross functional partners, a global launch plan aligned to the global brand strategic imperativesIncludes elements such as positioning, strategic imperatives, value story, TPPs, & global forecastingDevelop a robust global launch plan to ensure optimized launches in INsmed markets and that efficiencies are realized where possibleCo-Chair Global Asset Team Act as the central point for asset and liaison to executive team with critical support from functionsCo-lead GAT with the Global Clinical Lead, driving overall brand strategy including indication strategy/sequencing, TPP & protocol alignment, clinical development plan, regulatory strategy, manufacturing and supply chain etc. to ensure all indications are optimized and that decisions are aligned.Single point of oversight on functional sub teams supported through strong program management partnering and operational support and communicationAdditional Responsibilities Understand the diverse skills of extended team, ensuring team members are being led most effectively based on their abilities and styles.Collaborate with global commercial effectiveness/operations partners to ensure alignment and shared lessons across forecasting, insight generation and incentive compensationDevelop US and global cross-functional collaboration on key projects in conjunction with other functions.Supervise launch activities, ensuring timelines are met and downstream impacts are understood and handled effectivelyCollaborate with Financial Planning and Analysis (FP&A) and US Leadership Team (USLT) to develop and present revenue forecasts aligned with corporate objectives.Qualifications Bachelor's degree requiredMinimum of 12+ years of commercial (sales/marketing/field operations/market access) in a biopharmaceutical company (management, sales & marketing) experienceMinimum of 8+ years of leadership experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resourcesDemonstrated success leading teams tasked with launching products in the US marketTrack record of leading cross functional teams with strong interpersonal and communications skills, and ability to influence.Ability to develop and communicate a clear vision aligning to corporate and commercial objectivesCapability to thrive in a fast-paced and evolving organization, adapting to changing external and internal dynamicsField sales and management experience preferredRare disease / respiratory experience preferredLaunch experience requiredHigh learning agilityExcellent leadership ability with experience in building and leading high performing teamsProficiency in understanding data, tools and processesProficiency in data analysis and interpretation, applying insights to drive informed decision-making.Ability to think strategically in order to continuously improve processesAbility to work closely with the global teams to understand regional variations in commercial strategiesDemonstrated leadership focused on getting resultsFamiliarity with biotech product life cycles, from development through to commercialization.Consistent track record of success through teamwork and executionLocation and Travel Based in our Bridgewater, NJ headquartersUp to 30% travel Salary Range
00 Compensation & Benefits
At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:Flexible approach to how we workHealth benefits and time-off plansCompetitive compensation package, including bonus Equity Awards (Long-Term Incentives)Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here .
Additional Information
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis . click apply for full job details
Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions
Consistently Ranked Science's Top Employer
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row.
A Certified Great Place to Work
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma , Best Workplaces in New York , PEOPLE Companies That Care, Best Workplaces for Women , Best Workplaces for Millennials , and Best Medium Workplaces lists.
Overview
The Senior Director is the DSPV medical expert for assigned products and maintains current knowledge of assigned product portfolio and safety profiles. This individual will provide the day-to-day direction to the Medical Safety Team to ensure business needs and priority tasks are efficiently completed on time and in accordance with all relevant company and regulatory policies and procedures. In addition, the Senior Director will be responsible, globally, for implementing the safety and risk management activities for clinical development; be responsible for safety surveillance, risk management, and risk communication for assigned development products; perform medical assessment of individual adverse event reports generation; and review aggregate reports and safety documents, including labeling changes. This role provides DSPV support for internal and external customers. This position reports to the Executive Director (ED), DSPV and will provide coverage for the ED, DSPV during his absence. Responsibilities Leads strategic consultation, and guidance to the PV scientists on decisions that have significant drug safety implications, including safety signal detection activities of monitoring, evaluation, interpretation and appropriate management and communication of safety information for Insmed's portfolio of products in development. Responsible for appropriate review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process for assigned products and development compounds.Delivers high quality and timely medical safety deliverables. Provides content and functional approval, as needed, for all safety documentation in collaboration with the Executive Safety Committee. Responsible for conducting safety signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information.Leads the Safety Review Team(s) for assigned products and development compounds, and responsible for the management of ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents for assigned products and development compounds.Provides medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).Works with the ED of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products.Delivers key content of Risk Management documents (RMPs, REMS) of assigned products.Writes periodic reports for assigned products; provides medical interpretation, review, and approval for required reports.Shares DSPV and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.Provides expert safety input to the clinical development program for assigned products and development compoundsLeads the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develops/provides input to product Benefit-Risk Assessments, Company Core Data Sheet, Investigator's Brochure and Risk Management Plans (RMPs), and Risk-Evaluation and Mitigation Strategies (REMS).Ensures, in collaboration with Regulatory Affairs labeling team, an accurate representation and communication of the safety profile of assigned products and development compounds.Prepares responses to inquiries from regulatory authorities on safety issues for assigned products. Leads the integrated safety input into all regulatory documents where required.Performs detailed assessment of safety profiles for Due Diligence project.Provides Drug Safety input for product recall issues or Health Hazard Evaluations and "Dear Health Care Provider" letters.Performs the medical review of all adverse event reports for seriousness, expectedness and causality.Maintains and evaluates Medical Safety metrics and quality plan, including execution of metric reports, creating summaries of metrics, identifying any possible issues, creating an action plan, and communicating metrics to appropriate teams and individuals. Identifies concerns and champions issue resolution.Leads all aspects of medical safety and pharmacovigilance activities conducted in partnership with external business partners or outsource to vendors and contract research organizations (CROs).Evaluates, monitors, and oversees strategic drug safety company policies and regulatory requirements on safety data reporting, collection, surveillance activities, and documentation. Ensures that safety-related project landmarks are met within required timelines.Reviews scientific literature and identifies case reports that meet criteria for entry into the safety database; identifies relevant safety articles / references involving the active ingredients of marketed products and products in development; and builds literature summary sections to be included in PSURs and other required reports.Ensures audit and inspection readiness of the function at all times.Job Requirements:M.D. or D.O. required; MPH (Master of Public Health) is a plus.2+ years of Clinical Patient Care experience strongly preferred.8+ years of pharmaceutical industry experience within Drug Safety/Pharmacovigilance working with both investigational and marketed products.5+ years of demonstrated experience with medical case reviews, aggregate reporting, safety surveillance, signal management, and/or risk management.Ability to review and/or prepare scientific or regulatory documents from large volumes of scientific information.Experience presenting drug safety topics for regulatory authorities or at conventions, meetings, etc. A background in providing product defense before a national or international regulatory authority is a plus.Must have excellent communication skills (verbal and written).Global Pharmacovigilance experience, including robust knowledge of global PV regulations and applicable ICH guidelines is strongly desired.Experience in drug development and clinical trial methodology with rare disease experience preferred.Experience in preparing clinical safety assessments and regulatory reports/submissions involving safety information.Experience leading roles in clinical or safety through the complete submission process.Experience in presenting clinical or safety data to major health authorities.Strong leadership skills including mentoring, motivating, directing, and fostering collaboration.Experience in leading cross-functional, multi-cultural teams.Ability to develop and maintain effective working relationships with subordinates, superiors, and peers.Strong negotiation and conflict management skills.Drug safety database knowledge preferred.Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat digital literacy.
Salary Range
$283,000 - $339,000 a year Compensation & Benefits
At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:Flexible approach to how we workHealth benefits and time-off plansCompetitive compensation package, including bonus Equity Awards (Long-Term Incentives)Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here .
Additional Information
. click apply for full job details
Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions
Consistently Ranked Science's Top Employer
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row.
A Certified Great Place to Work
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma , Best Workplaces in New York , PEOPLE Companies That Care, Best Workplaces for Women , Best Workplaces for Millennials , and Best Medium Workplaces lists.
Overview
As the Director, Patient Advocacy & Engagement, you will play a pivotal role in building and leading patient advocacy and professional society engagements in respiratory, with a focus on PAH and PH-ILD, Your primary focus will be on cultivating positive relationships with patient communities, advocacy groups, and individual patients, to better understand their needs, experiences, and challenges. You will be instrumental in providing the patient voice and perspective as we design and implement our clinical development programs. You will be the bridge between patients, patient organizations, and our organization, ensuring their perspectives influence our decision-making processes, clinical development strategies, and patient support initiatives. You will lead the strategic review of educational funding requests, taking requests from review through to approval and contracting. You will ensure all policies and processes are followed, especially when it comes to CME guidelines. You will advise internal customers, both medical and marketing on the development of company led education. Responsibilities Patient & HCP Advocacy and Engagement:Develop and implement a Patient Organization engagement strategy aligned to internal business needs and patient community needs.Collaborate and co-create with Patient Organizations to identify and implement innovative initiatives to empower patients to seek optimal and informed care.Participate and support Patient Organization events, workshops, and conferences to promote awareness and cultivate patient community engagement.Collaborate and co-create with Professional Medical Associations to identify and implement innovative initiatives intended to address the evolving medical science related to Insmed therapeutic areas, as directed.Provide insight into Health Policy and Access & Reimbursement trends to ensure Patient Organizations have a thorough understanding of the access and reimbursement landscape.Patient Engagement:Implement a systematic strategic framework to ensure patient experience is incorporated into all critical business decisions across the asset lifecycleEngage with patient advocacy groups, foundations, and individual patients to see their point of view and needs as it related to Patient-Focused Drug DevelopmentEstablish and maintain strong relationships with key team members in the patient community.Patient-Centric Strategy:Collaborate with cross-functional teams to ensure patient perspective is internally understood and incorporated into company culture.Collaborate with cross-functional teams to ensure patient needs are considered at all stages of product development.Represent the company in external forums and conferences related to patient advocacy.Collaborate with cross-functional teams to ensure patient perspective is internally understood and incorporated into company culture.Collaborate with cross-functional teams to ensure patient needs are considered at all stages of product development.Represent the company in external forums and conferences related to patient advocacyCollaborate with Corporate Communications, Human Resources, Legal, and Compliance to ensure that Insmed's core values and corporate brand are represented in internal and external initiatives.Cultivate a collaborative and supportive team culture to achieve patient-centric goals.Qualifications:Bachelor's degree in life sciences, healthcare, public health, or related fields (advanced degree preferred).Proven experience in patient advocacy/engagement or related roles within the biotechnology, pharmaceutical, or healthcare industries, preferably with experience in the pulmonary and cardiology therapeutic areas.Strong understanding of respiratory diseases, with an ability to communicate complex scientific concepts to diverse audiences.Consistent track record of performance in developing and driving strategic projects, including managing budgets.Excellent communication and interpersonal skills to engage with patients, advocacy groups, and internal team members effectively.Deep experience working across multiple therapeutic areas and prioritizing appropriately.Demonstrated peer leadership experience and ability to inspire and motivate a matrixed team.Deep emotional intelligence for patients and their families, with a passion for advocating on their behalf!Knowledge of regulatory and ethical considerations related to patient advocacy and engagement.Passionate about making a difference in the lives of patients with serious and rare disease.Experience working in an early-stage and/or mid-cap sized company highly desired.Familiarity/experience with regulatory and pharmaceutical legal promotional review processesHighly organized with a strong attention to detail, clarity, accuracy, and conciseness.Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).Must successfully exhibit Insmed's five (5) corporate values: Collaboration, Accountability, Passion, Integrity & Respect; along with any other position specific competencies.Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace!Travel:Ability to travel (10%-20%) within North America and internationally (if required) to attend conferences, meetings, and patient events -SK1 - Hybrid Salary Range
$171,000 - $239,667 a year Compensation & Benefits
At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:Flexible approach to how we workHealth benefits and time-off plansCompetitive compensation package, including bonus Equity Awards (Long-Term Incentives)Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here .
Additional Information
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science's Top EmployerInsmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma , Best Workplaces in New York , PEOPLE Companies That Care, Best Workplaces for Women , Best Workplaces for Millennials , and Best Medium Workplaces lists. Overview The Director, Scientific Publications is a core member of Medical Strategy and Communications team and leads the development and execution of publication plans, including incorporation of strategic digital extenders and patient/lay facing publications, for their assigned therapeutic area within the respiratory franchise. This role will have high visibility within the medical organization and requires the ability to lead cross-functional teams in a matrixed organization. The Director will work closely with the cross-functional data generation team (Medical Affairs, HEOR, Biometrics, Clinical Development) and engage with healthcare professional experts and authors. The role will ensure compliance with publication-related policies and procedures. Title will be determined upon evaluation of credentials and experience. Responsibilities Responsibilities (Essential Role Responsibilities):Be a subject matter expert and internal liaison for the assigned therapeutic area(s) within the Insmed respiratory franchise with ability to work independently and lead/ influence cross-functionallyLead and facilitate comprehensive cross-functional global publication planning, including generation and execution of annual publication plans and presence at scientific congresses, with an understanding of how these activities support the overall business strategy, and including identification and prioritization of regional and local publication needsExecute publication plans including leading agency partners to ensure delivery of accurate and appropriate publications on time, within budget, and adhering to policyManage and track overall publication strategy budget overseeing vendor selectionPartner with the Scientific Communications lead to support the incorporation of published data into medical materials (eg, field medical, medical affairs training)Ensure the publication development process and all materials produced are in compliance with Insmed policy and guidelines including ICMJE, PhRMA, and GPPLeverage best practices and implement efficient processes to optimize publication efforts across medical affairsPosition Requirements (Required and/or Preferred Skills, Experience and Education):Master's degree in a scientific discipline, advanced degree preferred (PhD, PharmD or MD)Previous experience in pulmonology/respiratory or allergy/immunology therapeutic areas is strongly preferred.At the Director level, a minimum 5-10 years of relevant experience in the pharmaceutical/biotech industry, primarily in Medical Affairs publications function is required, with a proven track record of achieving results in a complex and dynamic settingExpert knowledge of relevant guidance including, but not limited to International Committee of Medical Journal Editors (ICMJE), Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines, CME Open Payments reporting, Good Publication Practice (GPP)Certified Medical Publication Professional (CMPP) credentialed highly preferredMinimum 5 years' experience demonstrated success in design and implementation of Scientific Publications Strategies including oversight to formal needs assessment and other relevant activitiesDemonstrated expertise in understanding and the application of scientific/clinical data to external dissemination to healthcare professionals, medical community and key collaboratorsExcellent written and verbal communication skills, with the ability to understand and effectively communicate complex scientific and clinical data to internal and external collaboratorsDemonstrated ability to work effectively within collaborative and cross-functional teamsMust successfully exhibit Insmed's five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies!Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace! Salary Range $179,000 - $250,800 a year Compensation & Benefits At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:Flexible approach to how we workHealth benefits and time-off plansCompetitive compensation package, including bonus Equity Awards (Long-Term Incentives)Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here . Additional Information Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science's Top EmployerInsmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma , Best Workplaces in New York , PEOPLE Companies That Care, Best Workplaces for Women , Best Workplaces for Millennials , and Best Medium Workplaces lists. Overview The Director of Medical Affairs Biostatistics is a highly visible role and is responsible for the statistical leadership and expertise to collaborate closely with the Medical Affairs organization to support evidence generation and publication strategy. We are seeking an experienced and strategic statistician to join our dynamic Biometrics Medical Affairs team. Responsibilities Lead the Medical Affairs statistical activities for one or several compounds.Represent the Biostatistics team within cross-functional teams, being accountable for statistical aspects of post-marketing studies, Real-World Evidence (RWE) studies, Heath Technology Assessment (HTA) submissions and publications.Oversee timelines and the quality of statistical analyses conducted by both CROs or internal teams.Independently undertake advanced statistical methods to support medical decision-making and evidence generation across Medical Affairs activities.Promote collaboration across Biometrics and other cross-functional teams, ensuring effective communication and the integration of statistical expertise into key business decisions.Contribute to department and transversal initiatives, supporting organizational growth.Provide technical guidance and mentorship to junior statisticians.Position Requirements (Required and/or Preferred Skills, Experience and Education):Ph.D. in Statistics or Biostatistics with over 8 years of pharmaceutical experience.Strong knowledge of pharmaceutical environment and broad experience with multi-phase development.Strong knowledge and in-depth understanding of advanced statistical concepts and techniques applicable to clinical research.Strong project management, interpersonal and communication skills.Ability to influence and contribute to the advancement of innovative statistical methodologies.Hands-on experience in designing and analyzing clinical trial data, with proficiency in SDTM and ADaM datasets and statistical software such as SAS and R.Prior experience in HTA, RWE and post-marketing studies is higher desired.Up to 10% travel Remote (only in corp. office for purposeful meetings) Salary Range $179,000 - $250,800 a year Compensation & Benefits At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:Flexible approach to how we workHealth benefits and time-off plansCompetitive compensation package, including bonus Equity Awards (Long-Term Incentives)Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here . Additional Information Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science's Top EmployerInsmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma , Best Workplaces in New York , PEOPLE Companies That Care, Best Workplaces for Women , Best Workplaces for Millennials , and Best Medium Workplaces lists. Overview The Senior Director of Forecasting will be responsible for evolving Insmed's capabilities in forecasting, including developing strategy related to forecasting methodologies, processes, and technologies that will enhance decision-making and planning across the organization. This role will be a key member of the Commercial Effectiveness team and will partner closely with cross-functional stakeholders (e.g., Marketing, Sales, FP&A) to optimize estimation and articulation of the commercial opportunity. This is a hands-on role that requires an entrepreneurial mindset and a willingness to execute all aspects of forecasting, from modeling through to creating a narrative and driving the company to action. The position will be in Bridgewater, NJ and may require some travel. This is not currently a supervisory position but may have responsibilities in the future. Responsibilities Responsibilities: We are seeking a highly experienced and innovative forecasting leader. The person in this role will be responsible for:Leading development of US forecasts across multiple products and indications, as well as guiding and maintaining forecast models across regionsCollaborating closely with regional Commercial Effectiveness teams to ensure consistency of forecast assumptions across countries, when possible, and to ensure clear messagingLeading the consolidation of global forecasts and maintaining an up-to-date view of key risks and opportunities in the short, mid and long-termDriving consolidation and delivery of the forecast narrative to senior leadershipProposing methodology, process improvements, and technology solutions, then getting buy-in from cross-functional leaders and leading implementation of such solutionsIntegrating secondary data analyses and primary market research insights to support forecast assumptionsCollaborating with analytic teams on the tracking of product performance vs. forecast expectations Working closely with vendor partners to identify analogs and benchmarks to support forecast assumptionsSharing best practices, innovating, driving efficiencies, and partnering with regional forecasting teamsStaying updated on market evolutions and dynamics relevant to Insmed products/pipeline, proactively updating forecasts with material market eventsKnowledge & ExperienceExtensive knowledge of pharmaceutical data (e.g., sales, specialty pharmacy, payer, promotional & marketing data, longitudinal patient-level data)Experience with launches and commercialization of pharmaceutical products (specialty drug/respiratory launch experience preferred)Strong blend of technical proficiency, business acumen, and experience informing business growth and opportunityExperience within the US market (experience with global markets beneficial)QualificationsBachelor's degree in Business, Finance, Engineering or related discipline required (MS, PhD, MBA or other advanced degree preferred)10+ years of leadership experience in demand forecasting within a pharmaceutical/biotech company or healthcare consulting firm (will consider related experience)Expertise in developing product forecasts, market assessments, and competitive intelligence analysesProven track-record of working with senior leadership on forecast development and communicationStrong quantitative and analytical skills, with the ability to translate complex data into actionable insightsCollaborative and influential leadership style, with the ability to build strong partnerships across the organizationSkillsExperience with secondary data e.g., APLD medical claims data, audited TRx data (IQVIA or Symphony Health), and epidemiology references High proficiency in MS Office (Excel/Access/PowerPoint)Experience with advanced analytical modelingAgile team player; able to adapt and execute based on evolving business needs, with strong active listening skillsAbility to extract and quickly process key information, summarize needs of cross-functional teams, and provide targeted and appropriate insights and recommendationsStrong verbal and written communication skillsAbility to work across culturesSkilled at leading without authority in a cross-functional environmentAbility to work in a fast-paced environmentAttention to detail and accuracy Salary Range $207,000 - $289,867 a year Compensation & Benefits At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location: Flexible approach to how we workHealth benefits and time-off plans Competitive compensation package, including bonus Equity Awards (Long-Term Incentives)Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here. Additional Information Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.
