Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Scientific Director/Scientific Director
on our Oncology Quantitative Translational Science team 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.
- The Associate Scientific Director/Scientific 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
- 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.
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.
- Knowledge of tumor immunology with demonstrated experience in the development of immuno-oncology therapies and novel therapeutic modalities (e.g., bi-specifics, ADCs, cellular therapies) is highly desirable.
- 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
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.