Senior Director, Quantitative Clinical Pharmacology Lead

Takeda Pharmaceutical Company • Cambridge, MA

119d • $208,200 - $327,140 • Remote

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 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 lifechanging 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.

Requirements

• Ph.D. with 16+ years or Pharm D. with 16+ years or M.S. with 18+ years or B.S. with 16+ years of experience in pharmacometrics, clinical pharmacology, pharmacokinetics, or other relevant experience.

Responsibilities

• Manages strategic, scientific and operational aspects of multiple 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 as 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.
• Provides scientific and strategic leadership as the Clinical Pharmacology Lead for multiple 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.
• 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 across the development continuum.
• 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.
• Oversees and/or independently performs PK/PD analyses including the interpretation of PK/PD data and associated statistical analyses.
• 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 assigned programs.
• Participates as a member of Business Development due diligence, when required.

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time per calendar year
• Accrual of up to 120 hours of paid vacation for new hires

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree