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 team, you will be empowered to manage strategic, scientific and operational aspects of multiple drug development programs from the clinical pharmacology perspective, and a typical day will include:
- The Associate Scientific Director/Scientific Director manages strategic, scientific and operational aspects of multiple drug development 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.
- 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 (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.
CORE ELEMENTS RELATED TO THIS ROLE
- This role will be expected to be the primary point of accountability in QCP at the asset level for assigned programs and will provide scientific and strategic input as the Clinical Pharmacology Lead on the respective Global Program Teams and associated scientific and operational sub-teams.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Demonstrated expertise in application of PK/PD, modeling and simulation, and use of clinical biomarkers for decision making.
- 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.
- Effective at building alliances across functions.
- Excellent interpersonal communication skills, able to drive global collaborations in cross-functional, multi-cultural organizations.
- Excellent oral and written communication skills, including writing, reviewing and editing scientific documents.
- Ability to effectively influence colleagues and multi-disciplinary project teams.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Associate Scientific Director Level: Ph.D or Pharm D. w/ 10+ years or M.S. w/ +12 years or B.S. w/ +15 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience.
- Scientific Director Level: Ph.D w/ or Pharm D. w/ 12+ years or M.S. w/ 14+ years or B.S. w/ 16+ years of experience in pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience.
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.