Associate Director, Quantitative Clinical Pharmacology (QCP) Lead
Takeda
August 19, 2026
Remote friendly (Boston, MA)
United States
$154,400 - $242,550 USD yearly
Clinical Research and Development
Position Objectives:
- Global/regional Clinical Pharmacology Lead for multiple projects; drive clinical pharmacology strategy from pre-FIH through life-cycle management and enable MIDD.
Responsibilities:
- Lead strategic, scientific, and operational aspects of multiple drug development projects with independence; primary responsibility for dosage selection and generation of causality evidence.
- Integrate pharmacokinetic, pharmacodynamic, efficacy, and safety data from multiple sources to optimize dosing for different populations.
- Draft and execute clinical pharmacology plans, integrating M&S, in collaboration with pharmacometrics, statistics, and DMPK.
- Enable MIDD practices and modeling/simulation approaches (e.g., QSP, MBMA) for internal decisions and regulatory interactions.
- Represent Clinical Pharmacology in meetings with global/regional regulatory agencies; prepare clinical pharmacology summary documents for regulatory submissions.
- Oversee and/or independently perform PK, PD, and pharmacometric analyses; interpret PK/PD data with DSI and external partners.
- Maintain good clinical practice, compliance, and ethics; mentor junior staff.
- Participate in Business Development due diligence (when requested) and contribute to infrastructure/cross-functional best practices.
Qualifications (Education/Experience):
- PharmD or PhD with 5+ years in a quantitative field with exposure to clinical pharmacology/PK-PD.
- MS with 8+ years in a quantitative field with exposure to clinical pharmacology/PK-PD.
Technical/Skills:
- Advanced clinical pharmacology experience across early/late stage and post-marketing studies.
- Advanced knowledge of drug development process and cross-functional interfaces (pharmacometrics, statistics, drug safety, clinical sciences, outcomes, digital health, pharma/device, global regulatory affairs).
- Advanced regulatory knowledge for trial design, analysis, and submissions (ICH, FDA, EMA, etc.).
- Hands-on integration of PK/PD/efficacy/safety data for dose selection and decision-making.
Benefits (if applicable):
- U.S. based employees may be eligible for medical/dental/vision, 401(k) with match, disability, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits; up to 80 hours sick time/year; paid vacation accrual up to 120 hours for new hires.
Application instructions:
- Apply via the “Apply” button (acknowledge processing of application information per Takeda Privacy Notice and Terms of Use).
- Global/regional Clinical Pharmacology Lead for multiple projects; drive clinical pharmacology strategy from pre-FIH through life-cycle management and enable MIDD.
Responsibilities:
- Lead strategic, scientific, and operational aspects of multiple drug development projects with independence; primary responsibility for dosage selection and generation of causality evidence.
- Integrate pharmacokinetic, pharmacodynamic, efficacy, and safety data from multiple sources to optimize dosing for different populations.
- Draft and execute clinical pharmacology plans, integrating M&S, in collaboration with pharmacometrics, statistics, and DMPK.
- Enable MIDD practices and modeling/simulation approaches (e.g., QSP, MBMA) for internal decisions and regulatory interactions.
- Represent Clinical Pharmacology in meetings with global/regional regulatory agencies; prepare clinical pharmacology summary documents for regulatory submissions.
- Oversee and/or independently perform PK, PD, and pharmacometric analyses; interpret PK/PD data with DSI and external partners.
- Maintain good clinical practice, compliance, and ethics; mentor junior staff.
- Participate in Business Development due diligence (when requested) and contribute to infrastructure/cross-functional best practices.
Qualifications (Education/Experience):
- PharmD or PhD with 5+ years in a quantitative field with exposure to clinical pharmacology/PK-PD.
- MS with 8+ years in a quantitative field with exposure to clinical pharmacology/PK-PD.
Technical/Skills:
- Advanced clinical pharmacology experience across early/late stage and post-marketing studies.
- Advanced knowledge of drug development process and cross-functional interfaces (pharmacometrics, statistics, drug safety, clinical sciences, outcomes, digital health, pharma/device, global regulatory affairs).
- Advanced regulatory knowledge for trial design, analysis, and submissions (ICH, FDA, EMA, etc.).
- Hands-on integration of PK/PD/efficacy/safety data for dose selection and decision-making.
Benefits (if applicable):
- U.S. based employees may be eligible for medical/dental/vision, 401(k) with match, disability, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits; up to 80 hours sick time/year; paid vacation accrual up to 120 hours for new hires.
Application instructions:
- Apply via the “Apply” button (acknowledge processing of application information per Takeda Privacy Notice and Terms of Use).