Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Scientific Director/Scientific Director of Quantitative Clinical Pharmacology in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Scientific Director/Scientific Director of Quantitative Clinical Pharmacology working on the Translational Research and Early Clinical (TREC) team, you will be empowered to lead for multiple programs at various stages of discovery, development and/or commercialization (small molecules, biologics, and other modalities like stem cell therapy) and a typical day will include:
- The Associate Scientific Director/Scientific Director manages strategic, scientific and operational aspects of programs from the clinical pharmacology perspective.
- Serves as the clinical pharmacology program lead for compounds in Phase 1-4 clinical studies. Works closely with functional experts across the R&D organization, such QS, DMPK, Research, Pharm Sci, TBR, 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.
- Co-leads cross-functional efforts
- Provides representation and leadership on strategic and operational cross-functional teams.
- Responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in collaboration with QS and DMPK. Ensures that M&S plans are fully integrated with the overall clinical pharmacology plans.
- Works closely with colleagues in QS to ensure appropriate quantitative support for the program is achieved.
- Creates or assists in the preparation of protocol synopses, oversees program execution including protocol conduct, data analysis, resolution of internal decision points and external regulatory interactions.
- Responsible for clinical pharmacology summary documents (such as IB, CTA).
- Performs PK/PD analyses or guides such analyses as appropriate.
- Maintains a high standard for good clinical practice, compliance and ethics.
- Mentors junior staff to ensure they value scientific excellence.
- Represents Takeda QCP in meetings with regulatory agencies and Health Authorities.
- When required participates as a member of Business Development due diligence.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Ph.D. or equivalent degree + 5-7 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience.
- Pharm.D. +7 years of clinical pharmacology, pharmacokinetic, pharmacometrics, or other relevant experience
- M.S. +10 years of clinical pharmacology, pharmacokinetic, pharmacometrics, or other relevant experience.
- B.S. + 15 years of clinical pharmacology, pharmacokinetic, pharmacometrics, other relevant experience.
- Educational degree in a relevant scientific area, e.g., Pharmacology, Pharmacometrics, Pharmacokinetics, Pharmacodynamics, Drug Metabolism, Pharmacy, or other related area.
- Demonstrated scientific and technical expertise through publications, patents, awards/honors or credibility at professional societies. Strong knowledge of allied fields critical for drug development, such as drug metabolism, pharmacology, toxicology, bioanalytical chemistry, and pharmaceutical science.
- Demonstrated experience with design and analysis of clinical pharmacology studies.
- Excellent understanding of and interests in PK/PD, modeling and simulation, and use of clinical biomarkers for decision making.
- Effective at building alliances across functions.
- Excellent interpersonal communication skills, able to drive global collaborations in cross-functional, multi-cultural organizations.
- Routine demands of an office based environment
- Access to transportation to attend various meetings held in proximity to the Takeda offices.
- Able to attend meetings at investigator, vendor or regulatory agency sites.
- Some international travel may be required.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.