Director, Quantitative Clinical Pharmacology (QCP) Lead
Takeda
June 26, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Clinical Research and Development
Director, Quantitative Clinical Pharmacology Lead (Hybrid) — Cambridge, MA
Position Objectives / Summary
- Lead clinical pharmacology strategy from pre-FIH through lifecycle management; partner with pharmacometrics to drive Model-Informed Drug Development (MIDD).
Responsibilities
- Lead strategic, scientific, and operational aspects of multiple drug development projects (dosage selection and causality evidence) from first-in-human through lifecycle management.
- Draft and execute clinical pharmacology plans with integration of modeling & simulation (M&S) in partnership 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 with global/regional regulators; author clinical pharmacology regulatory summary documents.
- Oversee and/or perform PK/PD and pharmacometric analyses and interpret PK/PD data with DQS and external partners.
- Maintain good clinical practice, compliance, and ethics; mentor junior staff; may lead a sub-team.
- Participate in BD due diligence (when requested) and lead cross-functional infrastructure/best-practice initiatives.
Qualifications / Skills
- PharmD or PhD with 8+ years (quantitative field) with exposure to clinical pharmacology/PK-PD; or MS with 12+ years.
- Extensive clinical pharmacology study design, analysis, and reporting.
- Experience leading MIDD scoping and implementation.
- Hands-on integration of PK/PD, efficacy/safety, biomarkers, RWE/RWD to support dose selection and quantitative decision-making.
- Regulatory submission experience (major NDA/CTD or supplemental NDA/CTDs).
- Strong knowledge of allied drug-development disciplines (statistics, DM, pharmacology, toxicology, bioanalysis, pharma science).
- Leadership in cross-functional decision-making and drug R&D success.
Benefits (as stated)
- U.S. base salary range: $177,000–$278,080; potential incentives; medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time and vacation.
Application Instructions
- No phone calls or recruiters please.
Position Objectives / Summary
- Lead clinical pharmacology strategy from pre-FIH through lifecycle management; partner with pharmacometrics to drive Model-Informed Drug Development (MIDD).
Responsibilities
- Lead strategic, scientific, and operational aspects of multiple drug development projects (dosage selection and causality evidence) from first-in-human through lifecycle management.
- Draft and execute clinical pharmacology plans with integration of modeling & simulation (M&S) in partnership 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 with global/regional regulators; author clinical pharmacology regulatory summary documents.
- Oversee and/or perform PK/PD and pharmacometric analyses and interpret PK/PD data with DQS and external partners.
- Maintain good clinical practice, compliance, and ethics; mentor junior staff; may lead a sub-team.
- Participate in BD due diligence (when requested) and lead cross-functional infrastructure/best-practice initiatives.
Qualifications / Skills
- PharmD or PhD with 8+ years (quantitative field) with exposure to clinical pharmacology/PK-PD; or MS with 12+ years.
- Extensive clinical pharmacology study design, analysis, and reporting.
- Experience leading MIDD scoping and implementation.
- Hands-on integration of PK/PD, efficacy/safety, biomarkers, RWE/RWD to support dose selection and quantitative decision-making.
- Regulatory submission experience (major NDA/CTD or supplemental NDA/CTDs).
- Strong knowledge of allied drug-development disciplines (statistics, DM, pharmacology, toxicology, bioanalysis, pharma science).
- Leadership in cross-functional decision-making and drug R&D success.
Benefits (as stated)
- U.S. base salary range: $177,000–$278,080; potential incentives; medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time and vacation.
Application Instructions
- No phone calls or recruiters please.