By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAbout the role:The Utilities Technician is responsible for the operation, maintenance, and troubleshooting of plant equipment that supports utilities including but not limited to high-pressure steam boilers; chillers; heating/cooling air handling units; process wastewater treatment systems; water purification system (water softening and carbon bed filtration, reverse osmosis, continuous deionization equipment, sanitary pumps, multi-effect distillation equipment); tank mixers; air compressors and dryers; and chilled water distribution systems under minimum supervision of the utilities supervisor in rotation shift environment.
Performs corrective maintenance and routine preventative maintenance on plant utilities equipment following Standard Operating Procedures (SOPs) as necessary. Completing work orders, logs and forms following cGMP documentation practices and Quality Standards in a Pharmaceutical Manufacturing facility is mandatory. This senior position is responsible for performing daily checks and maintenance on facility equipment and systems while adhering to cGMP standards and corporate safety policies.
How will you contribute:Perform preventive, corrective and predictive maintenance of all associated equipment.Operate and maintain various equipment through routine inspection and review.All work must be completed in accordance with cGMPs, SOPs, job plans, and company policies.Read, understand, and follow related SOPs and job/work plans.Ensure that forms and work order documentation are completed with accurate information.Responds to calls and conduct repairs throughout the facility. May be assigned to escort a contractor performing work on the premises.Provide support for the start-up of new equipment to ensure it meets all mechanical design specifications.Develop a proficiency in three or more advanced maintenance technologies and understand how to apply technology to improve equipment reliability, e.g., alignment, balancing, thermography, oil analysis, ultrasound, or vibration monitoring.Must follow safety rules and ensure compliance with GA state and federal EPA regulations and laws.Collect and Analyze daily WWTP as per procedurePerform chemical / parameter adjustment in WWTP as need it to maintain the system in compliancePerform Disposal of Hazardous WasteRespond to urgent and emergency work orders for the utilities department as needed.Responsible for closing assigned work orders in the CMMS (JDE, Maximo, SAP).Attend required Instructor Lead Training and planned team meetingsDemonstrate continuous progress with respect to increasing job knowledge and proficiency in technical understanding/problem-solving.Order and Maintain chemical inventoryKeeps designated area 5S'd. (Safety, Sort, Shine, Standardize, Sustain)Ability to teach basic activities and work execution to other technicians.Maintain a positive, professional, and customer-oriented attitude. Communicate any concerns related to safe work practices, hostile work environment, sexual harassment or any other type of employee misconduct directly to their supervisor, or management.This position will receive general instruction on routine work with detailed instruction on new assignments. Often will be assigned to work with a less experienced, utilities or maintenance technician.Primarily interacts with Plant Engineering Department personnel. Moderate interaction with other departments.May perform other duties as assigned.Provide a limited level of troubleshooting, diagnostic, and repair of building systems, equipment, and equipment components. Manufacturing equipment vessels, mixers, valves, and pumps.Operate general laboratory equipment to assess the analytical status of the utilities process.What you bring to Takeda:Typically requires a high school diploma or GED plus 8+ years of related industrial related experience. Pharmaceutical, utilities, and/or WWTP experience preferred.Two-year certificate in a technical field such as HVAC, building trades or building utilities program, or equivalent military experience is preferred.5-6 years of experience in the maintenance trades is preferredAbility to read and understand technical manuals and wiring schematicsMust have good customer service skills and promote a teamwork environmentMust have GA Industrial Wastewater Operator license or higher (or ability to get it within 90 days of employment)Ability to effectively communicate ideas through verbal and written form.Ability to read and understand procedures, schematics, and job blueprints.Familiar with CMMS, SAP, JDE, and or MaximoMust be able to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.Excellent technical troubleshooting/problem solving skills are a must. Must be knowledgeable with respect to the operation and maintenance of various utility systems including DAF, Centrifuge, Aeration Basins, Blowers, Pumps and others.Familiarity with Microsoft Office Applications, SCADA, process control software, and other computer base applicationsImportant Considerations:At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.Work in a cold, wet environment.Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.May be exposed to sunlight and heat.May be exposed to dust, gases, and fumes.May be required to stand and walk frequently while evaluating utilities equipment.May be around moving equipment and machinery.May climb up and into large tanks for inspection.May work in a loud area that requires hearing protection and other protective equipment to be worn.May be required to work or be assigned to a different shift as needed.Must be able to work 12-hour shifts and rotate(2/2/3) with assigned shifts.Overtime may be required at times.Requires performing activities within the plant utilities equipment, mechanical work, and computer-based activities.May be required to lift up to 50 pounds when managing chemicals.No travel is expected with this position.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ #ZR1 #LI-MA1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - GA - Social Circle - Hwy 278U.S. Hourly Wage Range:
$27.55 - $43.26
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - GA - Social Circle - Hwy 278Worker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
No Read LessBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAre you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
Here, you will be a necessary contributor to our inspiring, bold mission.
GOALS:
Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.
In close collaboration with Clinical Operations Program Lead(s):
Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.
The assigned clinical studies may be of low to medium level of complexity. More than one study and/or more than one program may be assigned.
ACCOUNTABILITIES:
Accountable for planning and operational strategy and execution for assigned clinical trials.
o Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.
o Challenges study team to ensure operational feasibility, inclusive of patient and site burden.
o Validates budget and ensures impacts are adequately addressed.
o Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy.
o Challenges study team to ensure timelines meet the needs of the clinical development plan.
o Ensure new team members and vendors are appropriately onboarded.
During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place.
Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly.
Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs.
Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.
Specific areas of sponsor oversight include, but are not limited to:
o Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring.
o Review and endorsement of relevant study plans, as applicable.
o Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes.
o Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study.
o Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies.
In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.
Ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.
EDUCATION AND EXPERIENCE:
BS/BA required, preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience.
Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.
5 or more years’ experience in pharmaceutical industry and/or clinical research organization, including 3 or more years clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA).
Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.
Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
Demonstrated successful experience in project/program management and matrix leadership.
Good communication skills.
Excellent teamwork, organizational, interpersonal, and problem-solving skills.
Fluent business English (oral and written).
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - VirtualU.S. Base Salary Range:
$103,500.00 - $162,690.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.#LI-Remote
Read LessBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Quantitative Clinical Pharmacology Lead in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
POSITION OBJECTIVES:
Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
Our Data and Quantitative Sciences group (DQS) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.
As part of DQS, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the pharmacometrics lead to drive a MIDD path within each project.
Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management. Possesses primary responsibility for dosage selection and generation of causality evidence.
Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives.
Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.
Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data and Quantitative Sciences (DQS) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.
POSITION ACCOUNTABILITIES:
Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams.
Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK).
Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches (e.g., QSP, MBMA) to inform internal decisions and external regulatory interactions.
Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions.
Oversees and/or independently performs PK, PD, and pharmacometric analyses including the interpretation of PK/PD data in close partnership with DQS and external partners.
Maintains a high standard for good clinical practice, compliance, and ethics.
Provides mentorship to junior staff, acts as a cross functional leader and may manage a sub-team within a TA.
Participates as a member of Business Development due diligence, when requested.
Leads infrastructure initiatives and/ or cross-functional best practice initiatives.
Demonstrates leadership in scientific societies and cross-industry consortiums related to the clinical pharmacology discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Desired education qualifications and equivalencies and desired minimum years industry experience:
Pharm D. or PhD with 8+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD
MS with 12+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD
Desired technical skills:
Extensive knowledge and experience with design, analysis, and reporting of clinical pharmacology studies.
Specialized clinical pharmacology expertise in multiple therapeutic areas, development phases, and/or different regions.
Experience in leading and driving the scoping and implementation of MIDD within projects.
Hands-on expertise/knowledge in application of advanced knowledge in integration of multiple data sources (PK/PD/Efficacy/Safety/biomarkers/RWE/RWD) across the asset to drive dose selection, optimized trial design, and quantitative decision making.
Experience in regulatory submission and approvals of at least one original/major NDA/CTDs or multiple supplemental NDA/CTDs (global or regional).
Experience in representing the QCP function in interactions with global or regional regulatory agencies at significant development milestones such as EoP2, pre-submission, and pediatric development plan (PIP and PWR).
Strong knowledge of allied fields critical for drug development, such as statistics, drug metabolism, pharmacology, toxicology, bioanalysis, and pharmaceutical science.
Ability to evaluate Benefit-Risk associated with project decisions, effectively manage GPT expectations and influence TA strategies.
Leadership in cross functional decision to optimize the likelihood of drug R&D success and utilization of the quantitative decision-making framework.
Drives efficiency using innovative processes and methodologies.
Accelerates regional development and filings through innovation (regional QCP).
Desired behavioral competencies:
Independently executes QCP deliverables and provides solutions to complex issues.
Consistently delivers with high quality and efficiency.
Elevates knowledge and enhances the capability of others.
Communicates effectively and influences in cross-functional teams.
Inspires commitment and enables cross-function collaboration.
Communicates success stories and shares learning across QCP.
Focuses on priorities and delivers on commitments.
This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
#LI-JV2
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MAU.S. Base Salary Range:
$177,000.00 - $278,080.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read LessBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAre you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Lead Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
Here, you will be a necessary contributor to our inspiring, bold mission.
GOALS:
Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s):
Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.The assigned clinical studies may be high complexity and/or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned.
ACCOUNTABILITIES:
Accountable for planning and operational strategy and execution for assigned clinical trials.Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.Challenges study team to ensure operational feasibility, inclusive of patient and site burdenValidates budget and ensures impacts are adequately addressed.Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy.Challenges study team to ensure timelines meet the needs of the clinical development plan.Ensure new team members and vendors are appropriately onboarded.During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place.Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly.Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs.Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.Specific areas of sponsor oversight include, but are not limited to:Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoringReview and endorsement of relevant study plans, as applicableStudy team meeting management and attendance when necessary; regular review of meeting agendas and minutesReview of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the studyDocumented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategiesIn partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.Ensure studies are “inspection ready” at all time; may be involved in regulatory inspections by preparing for and/or attending the inspections.Represent the Lead Clinical Study Manager role in functional initiatives or working groups. Help with onboarding and mentoring of new or junior CSMs.May assist the program COPL in his/her role, as requiredEDUCATION AND EXPERIENCE:
BS/BA required preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience.Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight. Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.Demonstrated excellence in project/program management and matrix leadership.Excellent communication skills.Excellent teamwork, organizational, interpersonal, and problem-solving skills.Fluent business English (oral and written).TRAVEL REQUIREMENTS:
Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - VirtualU.S. Base Salary Range:
$116,000.00 - $182,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.#LI-Remote
Read LessBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description Objective / Purpose: This Associate Director, Data Validation Engineer (DVE) role will work on Clinical Trial Reporting activities to deliver data listings and visualizations to facilitate the delivery of high-quality data in a timely manner, leading to statistical analysis and submission to regulatory authorities. This role partners with Clinical Data Management and works with Takeda study teams to develop listings and visualizations specifications, build and/or oversee implementation of data review objectives/artifacts for clinical trials to support the overall data review plan. In addition, this role will utilize and contribute to the development of libraries for listings and visualizations including functions and transformation templates for reuse for study level validation tasks. DVEs are responsible for maintaining, testing and documentation of programming tasks and ensuring compliance with trial master file requirements. This role operates in compliance with Takeda SOPs and processes while working closely with Clinical Data Operations Functions and others to enhance existing processes. Accountabilities: Provides clinical trial reporting expertise and leadership in support of global development programs as well as post-marketing registration and non-registration studies. Drives strategy with preferred vendors to ensure compliance to regulations and standards for associated technologies and development programs to ensure regulatory submission compliance. Partners with Data Configuration Engineer, and Clinical Data Standards teams in the development of standard and study specific data cleaning/quality checks, study status metrics, visualizations and monitoring reports. Organizes Clinical Trial Reporting activities for assigned clinical studies and non-clinical data cleaning activities Foster and ensure close collaboration with study team members (e.g., EDC Developers, Data Configuration engineer, Clinical Operations, Clinical Data Managers, Statistical Programmers, Statisticians and other stakeholders) in the clinical data lifecycle and in the development /maintenance/governance of standard data review objectives and libraries Assists with oversight of Functional Service Provider (FSP) resource allocation and strategic vendor partnerships to effectively deliver on internal and/or outsourced projects. Might be responsible for direct line management of employees. Establishes and maintains productive partnerships within Clinical Data Operations & Standards (CDOS), functional leaders across R&D, and third-party service providers. Responsible for the review, development, maintenance and optimization of processes to ensure that clinical trial reporting activities are in compliance with regulatory and company requirements Training and mentoring staff on key activities and processes. Recognizes development needs and identifies/creates development opportunities within team Supports the development of the clinical trial reporting talent base and identifies development needs within the area of responsibility Contribute to the enablement of technology strategies that support clinical program activities (e.g., Cross Function Data Review and Cleaning). Show influential strategic, execution and delivery leadership both within Takeda and outside of Takeda with vendors and partners. Participates in oversight to Global Development Operations technology vendors to ensure that they meet regulatory requirements and on delivery of accurate and efficient solutions to support therapeutic area management of global development programs. Represent function during internal audits and regulatory inspection in collaboration with Quality Assurance and GCP & Operational Excellence organizations. Confirm archival and inspection readiness of clinical trial reporting Trial Master File (TMF) documents Ensure compliance with own Learning Curricula, corporate and/or GxP requirements. Education & CompetenciesBS/BA in a health-related, life science area or technology-related fields. Minimum of 8+ years of drug development experience. 6+ years of project management and leadership experience Previous experience leading programming teams and influencing senior-level management and key stakeholders is a plus Experience in programming listings and/or visualizations with any of the following Veeva CDB, Elluminate and JReview Knowledge of clinical database systems (Metadata Rave, Veeva) and experience with any of these languages: CQL, SQL, SAS, R, Python Knowledge of data structures and data flow between clinical data management systems, vendor devices, and CDR. Experience with managing vendors and implementation clinical technologies: (e.g., Elluminate, Veeva CDB, CluePoint, Jreview, SAS, R, RShiny) Operational experience in pharmaceutical drug development with exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Knowledge of FDA and ICH regulations and industry standards and quality control principles as well as best practices related to computer system validation, electronic records and signatures and data privacy. Experience managing cross functional projects and developing successful partnerships within and across functional areas Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policyTakeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - VirtualU.S. Base Salary Range:
$154,400.00 - $242,550.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.#LI-Remote
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Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Vice President , Global Clinical Lead - Solid Tumor in our Cambridge office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
OBJECTIVES:
Responsible for leading as the Global Clinical Lead a large solid tumor oncology franchise that encompass multiple late stage and early phase programs . Ensures ongoing review and agreement of the Therapy Area Strategy and associated documents formulated by the OTAU leader prior to their review and approval by appropriate governance committees. Oversees the development and execution of the Integrated Disease Area Strategy (IDAS) and overall Integrated Global Development Plan (IGDP). Responsible for review of synopses, other relevant clinical study documents and critical Study Results. Provide leadership and oversight of specific OTAU related programs and if applicable other indication specific clinical leads. Responsible for providing guidance to TA leaders on regional specificities within Therapeutic Area.
ACCOUNTABILITIES:
Clinical Development team participation and leadership Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies.Consistent with the Takeda R&D Oncology Therapeutic Area Unit strategy, goals and objectives, this leader will partner with the other key functions and leaders and members of Oncology Precision and Translational Medicine, Oncology Portfolio Strategy Group, Global Regulatory Affairs, Quantitative and Clinical Pharmacology, other R&D Functional Line Oncology Therapeutic Area Leads, Global Product Launch Strategy Oncology Franchise Leads, Regional Oncology Franchise Leads, Oncology Drug Development Unit (DDU) and other Oncology extended leadership, to drive the alignment on global clinical research and development strategy as related to internal and external pipeline and non-pipeline initiatives for the Takeda R&D Oncology Community across all regionsPart of the Oncology Clinical Sciences Leadership Team providing key input in strategic planning and connectivity for the overall Oncology Clinical Sciences group Leads the Global Development Team (US, EU, and others) managing both the US/EU Development Team and the Japan/ China Development team for assigned compounds. In some cases may lead the US/EU Development Team but more likely will oversee the study physician and/or clinical scientist leads responsible for leading the team. Emphasis will be on insuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles.Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.Responsible for high impact global decisions: interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need.Accountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are appropriately briefed.Providing strategic input into global development strategies and plans for all compounds in OTAU. Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities)Primary interface with Medical Affairs team for strategy and to support of product commercial effortsContributing to the creation and maintenance of regional KOL networkProviding recommendations for GDT leader nominations and reviewers of external compounds as part of business development effortsLiaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementationSynopsis / Protocol Development, Study Execution, & Study Interpretation Consistent with membership of the Clinical Review Board Committee, responsible for critical review of synopses, protocols, IBs and relevant clinical documents relating to studies in assigned compounds. Trial Medical Monitoring Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds.External Interactions Oversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds. Responsible for evaluation of external interactions in the context of overall development strategies using complex problem solving in the region but in context of a global environment.Proactive identification of challenges and development of contingency plans as appropriate.Due Diligence, Business Development and Alliance Projects Responsible for evaluation of potential business development opportunities in the region but with the context of a global environment. Conducts due diligence evaluations, of clinical development plans for potential alliances and or in-licensing opportunities. Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner.Assigns and manages clinical science staff who are involved in many of these activities.Leadership, Task Force Participation, Upper Management Accountability Interacts directly with research division based on pertinent clinical and development expertise and in all aspects relating to assigned compound in regional area. Leads TGRD internal teams and global cross-functional teams. Works with functional leadership to prioritize projects within the therapeutic area.Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Experience
MD or combined MD/PhD or internationally recognized equivalent with minimum 15 years pharmaceutical research experience, including minimum 10 years late phase clinical development experience with a focus on medical oncology Clinical Training and Clinical Experience in Hematology/Oncology and/or Medical Oncology especially in solid tumor malignancies Strong depth of scientific and clinical understanding and experience in cancer biology especially in immune based therapies.Experience in conducting and/ or leading multiple clinical trials involving immune based therapies Proven experience in successfully leading and supervising direct reports including several physicians, physician scientists, scientists within a clinical development team in a global matrix environment.Demonstrated ability to foster a high-performance culture and build organizational capabilities.Strong leadership commitment to diversity, equity and inclusion, with experience in creating an inclusive and collaborative team environment that leverages diverse perspectives.Previous experience in successfully leading several clinical development team/matrix team with responsibility for Global studies in multiple regions. Clinical Development experience beyond US/EUSolid and Multiple experience in preparing and interacting with multiple regulatory agencies including FDA, EMA, and others Multiple NDA/MAA submission experienceProven ability to lead and manage highly trained medical, scientific, and technical professionals.Superior communication, strategic, interpersonal and negotiating skillsEnterprise level leadership with the ability to inspire, motivate and drive resultsExcellent communication both verbally and in writing and influencing skills, with the ability to engage, inspire, and influence stakeholders at all levels, including executive management and external partners.Ability to proactively predict issues and solve problemsAbility to drive decision-making within a multi-disciplinary, multi-regional, matrix teamsDiplomacy and positive influencing abilities across multinational business culturesTRAVEL REQUIREMENTS:
Willingness to travel to various meetings or client sites, including overnight trips. Several international travels may be required.Requires approximately 25-35 % travel.Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
#LI-JT1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MAU.S. Base Salary Range:
$321,000.00 - $504,460.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less