Senior Director Quantitative Clinical Pharmacology Lead
About The Position
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior 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 OBJECTIVE: The Senior Director manages strategic, scientific and operational aspects of multiple oncology/immuno-oncology programs from the clinical pharmacology perspective. Serves as the Global Clinical Pharmacology Lead for assets across phases 1-4 of development. Works closely with functional experts across the R D organization, such QS, Research, Biostatistics, Regulatory Affairs, DMPK, Pharm Sci, and Clinical Science providing leadership and guidance in clinical pharmacology activities. Assists in departmental management through program reviews and collaborative decision-making. Supervises and mentors junior staff providing professional and career development
Requirements
- Ph.D w/ or Pharm D. w/ 16+ years or M.S. w/ 18+ years or B.S. w/ 16+ years of experience in pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience.
Responsibilities
- Provides scientific and strategic leadership as the Clinical Pharmacology Lead for multiple oncology/immuno-oncology programs on Global Program Teams and associated scientific and operational sub-teams.
- Responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in collaboration with key partner functions (e.g., QS and DMPK).
- Ensures that M&S plans are fully integrated with the overall clinical pharmacology plans to enable Model-Informed Drug Development (MIDD).
- Works closely with colleagues in QS to ensure strategic integration of advanced modeling and simulation approaches (e.g., QSP, MBMA) across the development continuum to inform internal decisions and external regulatory interactions.
- Creates or assists in the preparation of protocol synopses, oversees program execution including protocol conduct, data analysis and reporting.
- Responsible for clinical pharmacology summary documents (such as IB, CTA, CTD Module 2 documents, product labeling).
- Oversee and/or independently perform PK/PD analyses including the interpretation of PK/PD data and associated statistical analyses in close partnership with external CRO partners.
- Maintains a high standard for good clinical practice, compliance and ethics.
- Mentors junior staff to ensure they value scientific excellence.
- Represents Clinical Pharmacology in meetings with global regulatory agencies for his/her assigned programs.
- Participates as a member of Business Development due diligence, when required.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
