Company Overview: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. Role Summary: The Associate Director, Clinical Business Operations provides support for clinical vendor outsourcing and financial oversight, tracking and forecasting for Dyne's clinical trials. This role is responsible for leading vendor identification and selection efforts in support of Dyne's Clinical trials ensuring cross functional input and evaluatoin. Work to optimize and ensure efficent spend within Clinical Operations. The Associate Director, Clinical Business Operations works closely with cross functional teams to ensure a fit-for-purpose outsourcing strategy and budget management is achieved for each trial. This role will work closely with other internal stakeholders including Finance, Legal and Quality. This role is based in Waltham, MA without the possibility of being a remote role.
Primary Responsibilities Include: Lead and manage the operational aspects of clinical business operations, including overseeing clinical trial budgets, vendor selection and relationship management Develop and implement strategic plans to optimize clinical business operations and ensure the efficient and cost-effective execution of clinical trials Collaborate with cross-functional teams, including clinical development, regulatory affairs, and finance, to align on trial execution plans and milestones Manage relationships with external vendors, CROs, and other partners to ensure high-quality deliverables, adherence to timelines, and budget management Assist in the development and management of clinical trial budgets, forecasting and expenses Ensure compliance with regulatory requirements, GCP guidelines, and company SOPs in all aspects of clinical business operations Provide leadership and mentorship to team members, fostering a culture of collaboration, continuous improvement, and excellence in clinical business operations Provide support of the Request for Information (RFI) and/or Proposal (RFP) process for Development programs and/or clinical studies of various phases, complexity, and risk Manage contract and financial negotiations with external service providers for Development programs Partner with the Legal to ensure that the appropriate templates and legal terms/conditions are applied Maintain current knowledge of outsourcing industry trends and provide ongoing support and training to key stakeholders on best outsourcing practices Proactively identify and collaborate to address opportunities for process or business improvements including operational efficiencies Embrace and enable diversity of perspectives to enhance the overall effectiveness of the team Represent Clinical Operations and support other functions on company-wide process improvements and initiatives Travel up to 25% domestic and/or international Education and Skills Requirements: Bachelor's degree; advanced degree (e.g., MBA, MPH) preferred At least 8 years of experience working within a pharmaceutical/biotech company, CRO, or similar organization Demonstrated leadership and project management skills, with a track record of successfully leading cross-functional teams and delivering results on time and within budget Excellent communication and interpersonal skills, with the ability to effectively collaborate and establish effective business relationships with internal and external stakeholders at all levels Experience in outsourcing management, vendor budget negotiations, budget management, and vendor oversight Experience in developing and implementing process improvements and operational efficiencies in clinical business operations Experience as a strategic partner providing effective and complex solutions and systems to the organization Comprehensive understanding of clinical trial operations regulatory requirements, with an understanding of clinical trial operations Strong analytical, negotiating and business communication skills. Ability to think strategically and effectively communicate ideas Able to interact and influence effectively with multi-functional teams at all levels of the organization Self-motivated and able to prioritize and manage a large volume of work in a dynamic, changing, growing start-up culture The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Company Overview: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. Role Summary: The Director, Scientific and Medical Education serves a critical role by supporting Dyne's portfolio of preclinical and clinical stage programs. The successful candidate in this role will be accountable for the development and execution of a comprehensive publication and medical education strategy across programs. The candidate will ensure that clinical and non-clinical data from Dyne's studies are communicated in an accurate, timely, compliant, and compelling manner through high-quality scientific publications, including manuscripts, abstracts, posters, and oral presentations. Additionally, this role will be responsible for the creation of internal and external medical education materials such as field medical decks, medical booth collateral, symposia, and internal onboarding and training resources. The Director will be closely partnered with other functions within the Global Medical Affairs team, as well as their counterparts in Clinical Development, Biostatistics, Research, and Corporate Communications to ensure cohesive planning and execution of Dyne's scientific and medical education strategy. This role is based in Waltham, MA without the possibility of being fully remote. Primary Responsibilities Include: Assist in the development and execution of a comprehensive, global publication and medical education strategy in line with individual Program and Corporate strategies Assist in developing Dyne's overall congress strategy and presence, including planning medical booth assets, symposia, scientific summaries, and presentations Plan and execute global medical communications initiatives (e.g., IME, roundtables) that support product strategy Provide medical oversight for scientific review and approval of communication materials and medical materials in compliance with corporate standards and government/industry regulations Serve as internal expert on medical literature and data Partner closely with Patient Advocacy and regional medical teams on the development of publications and educational materials for their respective audiences Collaborate with the Global Medical Affairs Leads to ensure alignment on individual program priorities and gaps that can be addressed with scientific and medical communications initiatives Maintain scientific communications platform up to date, and oversee the development of new ones, as needed Serve as a key member of the Global Medical Affairs team Education and Skills Requirements: Doctorate degree (MD, PhD, PharmD) with a minimum of 10 years of experience with a focus on rare diseases, neuromuscular experience, or related discipline Analytical skills, with a track record of delivering against goals while working in high performing, diverse teams Demonstrated success in operating effectively in highly matrixed organizations where influencing skills are critical to day-to-day success Ability to quickly adapt to new disease areas or therapeutic modalities Experience in building strong and effective relationships with thought leaders Experience in managing vendor partners Excellent written and verbal communication skills Travel up to 20% The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Company Overview: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. Role Summary: The Vice President, Head of Talent Acquisition is responsible for developing and executing a comprehensive global talent acquisition strategy that attracts, engages, and retains top-tier talent to drive enterprise success. This position is a leadership role that oversees all aspects of recruitment, employer branding, and talent pipeline development. This individual partners with senior leadership to align hiring initiatives with business goals, ensuring a competitive edge in talent acquisition and retention. Additionally, this position will oversee and build out the talent acquisition team both internally and externally and work collaboratively with team members across the organization at all levels to build a robust pipeline of talent that will support Dyne's growth and innovation This role is based in Waltham, MA without the possibility of being fully remote. Primary Responsibilities Include: Develop and implement a comprehensive and scalable global talent acquisition strategy aligned with the enterprise mission, vision, culture, and growth objectives Provide insight and leadership on industry, hiring, and engagement trends Collaborate with executive leadership and HR business partners to understand current and future hiring needs to assist with forecasting workforce needs and develop scalable, future-focused hiring plans Develop trust-based relationships across all functions and levels of the company; collaborate closely with HR Business Partners to understand business and talent priorities Collaborate with department heads, HR business partners, and hiring managers to understand their staffing needs and develop tailored recruitment plans Build and nurture relationships with industry professionals, universities, and other talent pools to create a robust pipeline of qualified candidates Own all recruiting aspects for senior leadership openings Oversee and work on continuous improvement of the full recruitment lifecycle, from sourcing and screening candidates to conducting interviews and extending offers Develop and implement effective talent acquisition strategies to meet the hiring needs of the organization Evolve interview and assessment process to improve data gathering and efficient talent decisions Establish and monitor key performance indicators (KPIs) and metrics to evaluate the effectiveness of recruitment efforts Develop and maintain recruiting analytics & reporting to better understand trends and talent activity; optimize talent systems to enhance candidate management and process flows Utilize data-driven insights to optimize recruitment processes and improve hiring outcomes Build and maintain a strong talent pipeline through proactive sourcing and networking Ensure a positive candidate experience throughout the recruitment process Prioritize and drive improvements for candidate experience as extension of our culture Stay up to date with industry trends, labor market conditions, and competitive hiring best practices to inform recruitment strategies Manage, develop, and build a strong, flexible talent acquisition team to meet evolving hiring and organizational design needs Partner with Communications on branding and external communication projects to attract top talent, including the development of recruitment marketing strategies and employee value proposition Champion our core values in all recruitment and assessment of candidates Manage Applicant Tracking Systems (ATS) and other recruiting software to streamline recruitment processes Ensure adherence to all federal, state, and local employment laws and regulations Education and Skills Requirements: Bachelor's degree in human resources, business administration, or a related field 15+ years of talent acquisition experience, with 5+ years of experience as the leader of the TA function, preferably within the biotech or pharma industry Strong ability to assess talent Strong understanding of talent sourcing strategies, recruitment technologies, and candidate assessment methodologies Full cycle recruiting experience with a passion for recruiting and a high bar on talent Proficiency in applicant tracking systems (ATS) and HR analytics tools Critical thinker with a demonstrated ability to collaborate with leadership and hiring teams, make thoughtful recommendations and drive alignment Demonstrated experience developing fit-for-purpose processes, analytics, and platforms that help streamline workflows, improve time to hire and ensure a diverse slate of high-quality talent Adaptable, resilient and embody high leadership & self-awareness capabilities Strong communicator and excellent influencer with ability to flex approach as needed to drive solutions Ability to build relationships at all levels of the organization Demonstrated experience in leading teams and driving organizational growth Knowledge of employment laws and regulations impacting recruitment practices Self-starter, able to drive work forward within fast-paced, dynamic and high growth environment with a track record of execution Expertise in building and executing talent acquisition strategies for both short-term needs and long-term organizational growth A startup mindset: adaptable, proactive, and ready to roll up your sleeves The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Company Overview: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. Role Summary: The Director, Program Management (PM) is a critical role within the cross-functional development team responsible for facilitating and driving execution across the wide spectrum of activities required for successful development of one or more molecules. The PM partners closely with Program Team Leader (PTL) and functional subject matter experts to ensure that plans are in place with appropriate detail and risk awareness to assure successful achievement of the goals of the development team. The PM ensures integration of these detailed functional plans into a holistic, cohesive and comprehensive program plan that achieves the strategic goals of the development program. Given the inherent uncertainty associated with drug development in rare disorders, the PM maintains an agile mindset in order to effectively incorporate and react to emerging data and course-correct as conditions dictate. Working in close partnership with PTL, the PM effectively frames and facilitates discussions with team members and external experts to elicit clear recommendations and decisions by fully engaging with team members to consider multiple options with a focus on impact on quality, time and cost. Their influencing and engagement skills allow them to work with a highly motivated team and manage stakeholders at all levels of the company. This individual is passionate about developing and commercializing life-transforming therapies for patients with severe and life-threatening diseases and will develop strong knowledge of the Dyne programs (scientific and clinical data, patient population, market environment, etc.). The Program Manager is adept at operating in cross-functional matrix teams, developing effective relationships based on mutual trust and effective communication and thrives in a fast-paced, patient-focused environment. This role is based in Waltham, MA without the possibility of being fully remote. Primary Responsibilities Include: Lead the operations of one or more high performing cross-functional team, with focus on both the "what", such as priorities, goal achievement, and resources, and the "how" of maintaining a challenging, collaborative, and sustainable team environment Partner with the PTL to identify short, medium, and long-term team priorities and propose path to address Drive execution of the established and aligned Program vision and strategy for bringing a life-changing medicine to patients in need Facilitate creation & maintenance of core program strategy documents including Target Product Profile (TPP), Clinical Development Plan, Regulatory Strategy, and Supply Strategy in collaboration with cross-functional representatives Ensure that non-clinical, clinical, regulatory, and commercial strategies and plans are aligned with the TPP and the overall Program Strategy Inspire development of an efficient plan to achieve development strategy, optimizing for quality, speed and cost Accountable for creation and maintenance of detailed cross-functional plans and effective visual summaries thereof to instill awareness, accountability and achievement Maintain clear and open communication with Program Team, Dyne Senior Leadership, and other stakeholders regarding program status, priorities, risks and needs, and facilitate appropriate strategic decision-making Keep abreast of emerging developments regarding research and development in the fields of muscle diseases and oligonucleotide drug discovery and development Foster a culture of collaboration, innovation, discovery, and cutting-edge research culture focused on scientific excellence, open communication, and continual improvement Education and Skills Requirements: Bachelor's degree in science or related field; Advanced degree in a scientific discipline or MBA preferred 10+ years of relevant experience in biotech/pharmaceutical industry in positions of increasing responsibility in drug development Exceptional communication skills (verbal, written, presentation) and ability to communicate with across a broad group of stakeholders and teams Proficient with SharePoint, Microsoft Teams, Smartsheet and other PM management workspace collaboration tools. Expert at cross-functional teamwork and influencing without direct authority Demonstrated experience in working with highly effective teams and guiding teams and organizations in making complex and high-stakes data-driven decisions Proven ability to establish and maintain credible and trust-based relationships Outstanding sense of urgency and ability to help pace the team's work in highly competitive environment Orientation towards collective achievement and team credit, combined with individual sense of responsibility and accountability for teamwork and product Comfort with ambiguity and ability to provide steadiness and consistency in environment of shifting priorities Ability to lead by influence complex and ambitious projects in a cross-functional team environment and high-pressure circumstances Comfortable in a results-driven, highly accountable environment where you can make a clear impact Team player who listens effectively and invites response and discussion A collaborator who communicates in an open, clear, complete, timely and consistent manner The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Company Overview: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. Role Summary: The Senior Director, Clinical Development will have primary responsibility for the design and oversight of Duchenne Muscular Dystrophy (DMD) clinical studies within an integrated development strategy, including both in-house development and potential strategic partnerships to augment the internally developed pipeline. This position will provide comprehensive leadership of the development process from pre-IND through to NDA and Phase IV programs. The Senior Director, Clinical Development will be responsible and accountable for the development of the medical aspects of DMD studies within the clinical program. This role will be responsible for delivering quality and timely medical input and interpretation on specific program data in fulfilment of the program and study objectives, working in partnership with Regulatory Affairs and Pharmacovigilance in providing medical support for pharmacovigilance activities, responses to regulatory agency queries, and development. This role is based in Waltham, MA without the possibility of being fully remote. Primary Responsibilities Include: Lead DMD Clinical Development study teams across planning, design, development, and implementation of clinical trials Provide Clinical Development guidance for clinical programs, including strategy, planning, execution, and completion of clinical trials according to all applicable regulations and guidance Develop and implement effective, timely, and cost-efficient clinical studies to establish the safety and efficacy of drug candidate compounds to achieve approval in the US and other countries Develop knowledge of disease mechanisms to select biomarkers, pharmacodynamic endpoints, functional outcome measures, and patient stratification considerations Actively contribute to Clinical Development and study team meetings to ensure close collaboration and alignment with key cross-functional stakeholders Serve as study Medical Monitor and medical representative to investigators, advisors, and regulatory agencies, as needed Coordinate with the Research group to assure smooth transition of development candidates/programs from research into development, including guidance on decisions that have clinical components and implications Collaborate with Pharmacovigilance to manage timely reporting of safety signals to regulatory agencies Collaborate with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance, maintaining the highest quality clinical programs, following GCP and ICH guidelines and the Company's standard operating procedures Maintain accountability for all relevant timelines, resources, and deliverables working closely with functional counterparts and colleagues on the integration of product and Clinical Development plans Develop and contribute to key documents including protocols, investigator brochures, and informed consent forms Develop and implement SOPs for clinical trials and related activities, as required Review presentations and publications (regulatory submissions, original peer-reviewed articles, abstracts) Select between outsourcing and in-house approaches for Clinical Development capabilities and work closely with the Clinical Operations team to implement choices Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other departments and third parties, such as CROs and external vendors, in order to ensure study objectives and timelines are accomplished Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians Support the Vice President, DMD Clinical Development with strategic development and implementation of integrated development plans, and provide timely updates on clinical studies and relevant workstreams Provide leadership and mentorship to Clinical Development team members, managing matrix and direct line reports Interface with departments within and outside of R&D including Regulatory Affairs, Legal, Finance, and Medical Affairs Identify, manage, and interface with external collaborators and key opinion leaders to create Clinical Development strategies for a novel class of therapeutics Develop and maintain professional relationships with academic and community-based study sites Education and Skills Requirements: Doctor of Medicine (MD), Master of Science in Nursing (MSN) or Doctor of Nursing Practice (DNP) with a strong scientific background and a specialty in neurology or neuroscience training highly preferred Minimum of 8 years of pharmaceutical industry experience Experience leading a clinical development program(s) in Neurology/ Neuromuscular disorders Experience with all aspects of designing, executing, monitoring, and managing clinical trials from inception to completion across all phases of development Robust regulatory experience with Pre-INDs, INDs, CTAs, EOP2 meetings and NDA/BLAs/MAA, both US and ex-US Proven track record of drug development with Phase 1 through 3 trial experience preferred Experience managing significant accelerations and challenges in clinical programs Strong knowledge of FDA and ICH regulations Thorough knowledge of clinical medicine, clinical pharmacology and associated disciplines Expert knowledge of Good Clinical Practice (GCP) Experience in a small to mid-sized biotech company is preferred Significant experience in communicating/presenting key/complex information to department/functional lead(s)/senior management Readiness to "roll up the sleeves" to contribute to team efforts Excellent writing skills with a track record of publications and polished presentation skills to influence internal and external audiences Ability to develop creative approaches to processes, practices, services, business models, and strategy Ability to translate basic science into a product development plan that will maximize the product's commercial opportunity Ability to work successfully in a matrix environment and effectively build consensus Communication skills (written and verbal), which are equally effective internally and externally, with large and small audiences, and one-on-ones Ability to effectively lead cross-functional meetings, and meetings with senior leaders to drive successful outcomes Ability to collaborate with and inspire high-performance clinical development team The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Company Overview: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. Role Summary: Medical Science Liaisons (MSLs) are the field-based extension of our Medical Affairs team. MSLs are scientifically trained professionals who possess strong clinical and/or scientific backgrounds whose role is to be a resource of balanced, impartial, and scientifically rigorous information to our patients, clinical study sites, study personnel and Key Opinion Leaders (KOLs). The Executive Director of the U.S. MSL team will be responsible for leading a team of U.S.-based MSLs that will facilitate enrollment in company sponsored studies, engage with clinical study sites, study personnel, KOLs, and other health care providers with scientific exchange and clinical support for investigational products. The MSL Team Leader will pair the changing needs of healthcare professionals with available Dyne resources. The U.S. MSL Team Leader will work under the guidance of the Global Head of Medical Affairs and in close collaboration with the Global Medical Affairs Leads (GMALs), EU Medical Affairs team, Clinical Operations, Clinical Development teams and Patient Advocacy. This role is based in the U.S. Primary Responsibilities Include: Build, train and lead an agile U.S. MSL Team and ensure strategic alignment with all field activities globally Stimulate and motivate people and teams to develop and execute medical excellence and medical leadership Develop and demonstrate a thorough working knowledge of Company, investigational products, and disease state, as well as competitors and treatment landscape Develop strategic and tactical KOL plans to enhance awareness of Dyne within the medical community and educate healthcare professionals on Dyne's platform and portfolio Involvement in the scientific and medical communication strategy and in any non-promotional material review as per procedure until market authorization (MA) is granted. Once the MA is granted, this person is responsible for the scientific review of any promotional material Ensure the dissemination of transparent, fair-balanced medical, scientific, and clinical information, knowledge, and literature, within corporate guidelines, for healthcare provider education in a timely, compliant, ethical, and customer-focused manner Ensure MSL team serves as liaison between clinical investigators and internal stakeholders in support of clinical research activities (e.g., company sponsored, investigator initiated studies) Develop, maintain, and manage collaborations with regional and national KOLs, investigators, study staff (site staff and CRO staff) Identify and build collaborations with KOLs for medical education and potential clinical research opportunities Think strategically to translate medical/clinical insights of treatment paradigms into growth opportunities, process improvement and driving competitive advantage Provide field-based medical and scientific support to answer unsolicited questions about Company, investigational products, and associated disease states Deliver high quality educational presentations in a variety of settings and obtain feedback that can be disseminated throughout the organization Participate in therapeutic advisory groups or Steering Committees and internal project teams, as appropriate Gather and disseminate competitive intelligence from multiple sources, internally and externally Attend regional / local conferences on Company's behalf to provide feedback on current landscape, competitive landscape and continued cultivation of relationships Provide feedback on specific sites and regional trends/thoughts/paradigms to identify and/or inform potential protocol amendments, accrual barriers, patient/study subject identification Complete accurate and timely administrative reports, projects, and other required documentation Education and Skills Requirements: Advanced scientific degree or equivalent required (e.g., MD, PhD, RN, PharmD, MA) Clinical experience within neuromuscular disorders (e.g., DMD, DM1) preferred; rare disease experience considered 5+ years experience as an MSL; preferably 3+ years as an MSL team leader (regional or national) Experience with relationship building and expanding a company's reach Ability to operate with ambiguity and thrive in an ever-changing environment Very high level of learning agility and communication skills encompassing: Strong comprehension of investigational products and a solid understanding of the neuromuscular space, including new data as it becomes available Ability to cultivate and maintain relationships with national, regional, and local KOLs to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through to requests from thought-leaders Professional communications (written, verbal, presentation, and listening) to cultivate and nurture strong working relationships with internal and external colleagues Demonstrated ability to work effectively on multi-disciplinary teams in order to achieve desired outcomes Demonstrated understanding of pharmaceutical industry practices, as well as standard medical practices in therapeutic area(s) of concentration and broad therapeutic competency (e.g., keeps current with new information and trends in the field) Ability to work independently, within a home office while efficiently managing a team, including the team's time and priorities Must conduct oneself in a highly professional and ethical manner; Demonstrated ability to liaise with CRO, Company Clin Ops, and Study Medical Monitor to provide site recommendations based on prior knowledge of territory/investigators/allied health; participate in SIVs Ability to leverage past relationships in neuromuscular disorders to ensure interest and commitment from sites/investigators for study enrollment and open communication re: feedback to Company Must be willing to travel extensively and occasionally on weekends The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Company Overview: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. Role Summary: The Senior Director, Program Management (PM) is a critical role within the cross-functional development team responsible for facilitating and driving execution across the wide spectrum of activities required for successful development of one or more molecules. The PM partners closely with Program Team Leader (PTL) and functional subject matter experts to ensure that plans are in place with appropriate detail and risk awareness to assure successful achievement of the goals of the development team. The PM ensures integration of these detailed functional plans into a holistic, cohesive and comprehensive program plan that achieves the strategic goals of the development program. Given the inherent uncertainty associated with drug development in rare disorders, the PM maintains an agile mindset in order to effectively incorporate and react to emerging data and course-correct as conditions dictate. Working in close partnership with PTL, the PM effectively frames and facilitates discussions with team members and external experts to elicit clear recommendations and decisions by fully engaging with team members to consider multiple options with a focus on impact on quality, time and cost. Their influencing and engagement skills allow them to work with a highly motivated team and manage stakeholders at all levels of the company. This individual is passionate about developing and commercializing life-transforming therapies for patients with severe and life-threatening diseases and will develop strong knowledge of the Dyne programs (scientific and clinical data, patient population, market environment, etc.). The Program Manager is adept at operating in cross-functional matrix teams, developing effective relationships based on mutual trust and effective communication and thrives in a fast-paced, patient-focused environment. This role is based in Waltham, MA without the possibility of being fully remote. Primary Responsibilities Include: Lead the operations of one or more high performing cross-functional team, with focus on both the "what", such as priorities, goal achievement, and resources, and the "how" of maintaining a challenging, collaborative, and sustainable team environment Partner with the PTL to identify short, medium, and long-term team priorities and propose path to address Drive execution of the established and aligned Program vision and strategy for bringing a life-changing medicine to patients in need Facilitate creation & maintenance of core program strategy documents including Target Product Profile (TPP), Clinical Development Plan, Regulatory Strategy, and Supply Strategy in collaboration with cross-functional representatives Ensure that non-clinical, clinical, regulatory, and commercial strategies and plans are aligned with the TPP and the overall Program Strategy Inspire development of an efficient plan to achieve development strategy, optimizing for quality, speed and cost Ensure that program decisions are made in a timely, clear and efficient manner through interactions with the PTL, Program Team members, governance forums and other key stakeholders Accountable for creation and maintenance of detailed cross-functional plans and effective visual summaries thereof to instill awareness, accountability and achievement Maintain clear and open communication with Program Team, Dyne Senior Leadership, and other stakeholders regarding program status, priorities, risks and needs, and facilitate appropriate strategic decision-making Keep abreast of emerging developments regarding research and development in the fields of muscle diseases and oligonucleotide drug discovery and development Foster a culture of collaboration, innovation, discovery, and cutting-edge research culture focused on scientific excellence, open communication, and continual improvement Education and Skills Requirements: Proven and respected team member with: Bachelor's degree in science or related field; Advanced degree in a scientific discipline or MBA preferred 8-12+ years of relevant experience in biotech/pharmaceutical industry in positions of increasing responsibility in drug development Experience with late-stage clinical development and commercial stage programs required Experience with neuromuscular diseases a plus Exceptional communication skills (verbal, written, presentation) and ability to communicate with across a broad group of stakeholders and teams Proficient with SharePoint, Microsoft Teams, Smartsheet and other PM management workspace collaboration tools. Expert at cross-functional teamwork and influencing without direct authority Demonstrated experience in working with highly effective teams and guiding teams and organizations in making complex and high-stakes data-driven decisions Proven ability to establish and maintain credible and trust-based relationships Outstanding sense of urgency and ability to help pace the team's work in highly competitive environment Orientation towards collective achievement and team credit, combined with individual sense of responsibility and accountability for teamwork and product Comfort with ambiguity and ability to provide steadiness and consistency in environment of shifting priorities Ability to lead by influence complex and ambitious projects in a cross-functional team environment and high-pressure circumstances Comfortable in a results-driven, highly accountable environment where you can make a clear impact Team player who listens effectively and invites response and discussion A collaborator who communicates in an open, clear, complete, timely and consistent manner The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Company Overview: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. Role Summary: The Director of Supply Chain Planning is responsible for end-to-end inventory and production planning across Dyne's external supply network. This includes long-range planning (LRP), ensuring uninterrupted clinical supply, and supporting commercial launch readiness through scenario-based planning and risk assessments. This strategic role is critical in executing current planning activities and shaping future supply chain capabilities. The Director collaborates cross-functionally with Process Development, Research, CMC, Quality, Clinical Operations, and Commercial teams. It is an opportunity to help shape the future of Dyne's supply chain function during a critical period of growth and innovation.
This role is based in Waltham, MA without the possibility of being fully remote. Primary Responsibilities Include: Collaborate with cross-functional partners in CMC, Logistics, Quality, Clinical Operations, and Commercial to develop and maintain a reliable demand and supply plan, ensure uninterrupted product availability for patients, support commercial readiness, and align with the company's business objectives. Maintain an understanding of external manufacturing site capacities, capabilities, and supply risks. Identify and implement opportunities to optimize supply chain processes and drive efficiencies. Lead scenario planning to evaluate alternative demand and supply assumptions and inform risk mitigation strategies. Lead monthly demand and supply planning meetings with cross functional team members as part of our drive to a formal Integrated Business Planning / Sales and Operations Planning process. Perform analysis of Dyne portfolio, including inventory projections, supply performance and risks. Integrate with other global planning processes to monitor key performance indicators (KPIs) and analyze supply chain data to identify opportunities for improvement and cost savings. Author Supply Chain-related standard operating procedures (SOPs) and work instructions. Manage relationships with third-party suppliers and vendors to ensure timely delivery of materials and components. Ensure compliance with regulatory requirements and quality standards in supply chain operations. Education and Skills Requirements: Bachelor's degree in Supply Chain, Business, Engineering, or a related field; advanced degree preferred. Minimum of 10 years of relevant experience in a biotech, pharmaceutical, or life sciences environment. Ability to effectively plan, prioritize, execute, follow up and anticipate challenges. Experience managing complex schedules and priorities in dynamic pharmaceutical, biotech or related environments. Ability to work, influence, and gain agreement across multiple functions. Strong analytical, problem solving and critical thinking skills. Strong knowledge of supply chain best practices, inventory management, and demand forecasting. Proficiency in advanced Excel functions and familiarity with planning and analytics tools such as Smartsheet, Visio, ERP systems (e.g., SAP, Oracle), and Power BI. Collaborative work style to be part of a team to identify process gaps and develop solutions. Excellent interpersonal, verbal, and written communication skills. Experience in supply chain, drug development, project management, and/or pharmaceutical manufacturing/packaging. In-depth working knowledge of regulations relating to clinical manufacturing, packaging and distribution activities (CGMP, GCP). APICS or CSCMP certification a plus. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Company Overview: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. Role Summary: The Senior Director, Drug Safety and Pharmacovigilance will play a key leadership role in characterizing the safety profiles of Dyne products and mitigating and communicating their risks throughout the product lifecycle (from First-In-Human to post-marketing). This role will provide short- and long-term strategic leadership of safety surveillance for Dyne's clinical development programs, including resource planning and long-range capability development to ensure high quality characterization of the safety profiles of Dyne molecules and compliance with all applicable US and foreign legal and regulatory requirements for pharmacovigilance, signal management and risk management. This role will oversee cross-functional Signal Detection and Safety Surveillance Teams, guiding the analysis, interpretation and presentation of safety data to stakeholders as needed. This role also contributes to the safety content of regulatory and study documents and collaborates actively with colleagues in numerous cross-functional departments. This role is based in Waltham, MA without the possibility of being fully remote. Primary Responsibilities Include: Conduct and/or oversee activities related to signal detection and evaluation, risk classification, management and communication, including leadership of Signal Detection and Safety Surveillance Teams, as part of continuous benefit-risk evaluation throughout the lifecycle of Dyne products from First-in-Human (FIH) to post-marketing Review safety data of non-clinical studies and from other sources to inform clinical development safety monitoring strategies and plans, including identification of safety-related biomarkers Contribute to the Safety Governance process through the preparation and presentation of safety data and provision of recommendations for review and approval by the Safety Management Committee Perform medical review of ICSRs in Dyne's Global Safety Database including but not limited to case narrative, MedDRA coding, causality, company comment and queries Develop Aggregate Safety Reports (ASR) such as Development Safety Update Report (DSUR), and responses to health authorities' requests for safety information Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), IB Reference Safety Information (RSI), Clinical Study Reports (CSR), Summary of Clinical Safety (SCS), Integrated Clinical Safety (ICS), Publications, and other relevant documents Provide strategic guidance and draft responses to safety-related requests and questions from Health Authorities Assist in planning the Pharmacovigilance Department budget, develop short-term and long-term goals for the department in accordance with overall Company and Development strategies Review safety content of scientific publications such as posters, abstracts, and manuscripts. Participate in cross-functional projects and teams Engage with external consultants and advisors as needed to inform interpretation of emerging safety signals. Serve as an exemplary leader, mentor, and trainer Education and Skills Requirements: MD is required Minimum 12 years' experience as a safety physician with the biotechnology / pharmaceutical industry, leading drug safety & pharmacovigilance, including cross-functional team leadership for signal detection, evaluation, risk classification and management, and communication, for products across multiple stages of development Experience with safety data visualization tools and other technologies supporting safety surveillance Excellent verbal communication and presentation skills with ability to write clearly and concisely, and to formulate science-based arguments in addressing questions regarding safety from Health Authorities and other parties, and in characterization of the safety profiles of Dyne molecules in development Experience in authoring DSUR and other aggregate safety reports Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines, and other local/global safety regulations, and ability to integrate relevant aspects of these documents into safety surveillance and reporting Line management / direct reports experience is strongly preferred In-depth understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies Strong knowledge of statistical methods used in PV Proven abilities to lead significant process improvements in PS Exceptional interpersonal skills and understanding of team dynamics. Understanding and application of pharmacology, chemistry and non-clinical toxicology to effectively inform the conduct of safety surveillance Ability to thrive in a fast-paced environment while providing appropriate attention to detail. Ability to effectively present recommendations / opinions in group environment both internally and externally The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Company Overview: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. Role Summary: The Clinical Operations Study Lead ensures that clinical strategies are translated into operational plans and executed in line with clinical development plans (CDPs). This position is responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives including aligning operational execution activities with agreed upon project priorities, timing, budget, and quality requirements. This position ensures study conduct adheres to all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Dyne's policies ad SOPs. This individual may be responsible for one highly complex or multiple medium complexity clinical studies. This role is expected to require up to 20% travel, including international travel. This role is based in Waltham, MA without the possibility of being a fully remote role. Primary Responsibilities Include: Manage all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance applicable SOPs, guidelines and regulations Develop study level operational strategy and clinical operations plans in support of execution of the Program-level objectives/CDP Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities Support the selection, oversight, and management of CROs and other vendors Monitor and assess vendor performance against contractual operational deliverables. Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors Provide oversight of study scope, quality, timelines and budget with the internal Dyne functional leads, CRO and vendors to ensure project objectives remain on track Lead cross-functional teams and manage study team in partnership with the CRO Participate in a site engagement program to builds solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities Responsible for planning and conducting investigator meetings together with the CRO Partner with the CRO to ensure patient enrollment strategies are carried out effectively and on time Coordinate and participate in proactive data monitoring activities to ensure quality and completeness of study data Evaluate issues, interpret data, and suggest and implement solutions and mitigation as required Create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate Provide ongoing oversight, maintenance and evaluate completeness of the TMF by performing periodic QC reviews to ensures the TMF and study is always "inspection ready" Prepare high-quality reports (financial, project, etc.) for senior management on program status and issues as required Provide management, oversight, coaching, mentoring, and development to team of indirect reports supporting the clinical trials team and cross-functional teams Education and Skills Requirements: Undergraduate degree in a scientific or health related discipline. Advanced scientific or business degree or equivalent experience desirable Minimum of 8 years of clinical trial management experience in conducting Phase I-III global clinical trials, preferably with both a sponsor company and CRO managing outsourced clinical trials within quality, timeline and budget expectations. Prior site and/or monitoring experience is advantageous Experience across several complex therapeutic areas; neuromuscular or muscle disease experience preferred. Experience with rare disease and/or pediatric trials also preferred Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, US/EU patient data privacy laws Understand clinical study budgets, accruals and forecasting Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously Enjoy building relationships with KOLs and site personnel with a willingness to travel to establish and build relationships Experience in vendor selection and overseeing studies being managed by a CRO Ability to successfully engage and work collaboratively with clinical operations team members/colleagues and other functions, including Medical Affairs and Commercial, as necessary Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Independently motivated, detail oriented and good problem-solving ability (think outside of the box mentality) Excellent communication skills The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
