Director, Quantitative Clinical Pharmacology (QCP) Lead
Takeda
August 08, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Clinical Research and Development
Position Accountabilities (Global/Regional Clinical Pharmacology Lead):
- Lead strategic, scientific, and operational aspects of multiple drug development projects with independence (from first-in-human through lifecycle), including dosage selection and causality evidence.
- Draft and execute clinical pharmacology plans, integrating Model-Informed Drug Development (MIDD) and modeling/simulation (e.g., QSP, MBMA) with pharmacometrics, statistics, and DMPK.
- Enable MIDD practices to inform internal decisions and regulatory interactions.
- Represent Clinical Pharmacology with global/regional regulatory agencies; prepare clinical pharmacology regulatory summary documents.
- Oversee and/or conduct PK/PD and pharmacometric analyses; interpret PK/PD data with DQS and external partners.
- Maintain good clinical practice, compliance, and ethics; mentor junior staff; may manage a sub-team.
- Lead infrastructure/cross-functional best-practice initiatives; may support Business Development due diligence.
- Participate in scientific societies/consortia (ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, DIA).
Qualifications:
- PharmD or PhD with 8+ years in quantitative field (clinical pharmacology/PK-PD exposure).
- MS with 12+ years in quantitative field (clinical pharmacology/PK-PD exposure).
Required/Preferred Skills:
- Design/analyze/report clinical pharmacology studies; expertise across therapeutic areas/phases/regions.
- Experience scoping/implementing MIDD; integrate PK/PD/efficacy/safety/biomarkers/RWE/RWD for dose selection and trial design.
- Regulatory experience with NDA/CTDs and agency milestone interactions (EoP2, pre-submission, PIP/PWR).
- Strong knowledge of statistics, drug metabolism, pharmacology, toxicology, bioanalysis, and pharma science; benefit-risk evaluation; cross-functional leadership.
Desired Behavioral Competencies:
- Independently execute deliverables; high-quality/efficient delivery; effective cross-functional communication/influence.
Work Mode: Hybrid.
Compensation/Benefits (Boston, MA):
- Base salary range: $177,000.00–$278,080.00; medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid time off, sick time, and up to 120 hours paid vacation for new hires.
Application Instructions:
- No phone calls or recruiters please.
- Lead strategic, scientific, and operational aspects of multiple drug development projects with independence (from first-in-human through lifecycle), including dosage selection and causality evidence.
- Draft and execute clinical pharmacology plans, integrating Model-Informed Drug Development (MIDD) and modeling/simulation (e.g., QSP, MBMA) with pharmacometrics, statistics, and DMPK.
- Enable MIDD practices to inform internal decisions and regulatory interactions.
- Represent Clinical Pharmacology with global/regional regulatory agencies; prepare clinical pharmacology regulatory summary documents.
- Oversee and/or conduct PK/PD and pharmacometric analyses; interpret PK/PD data with DQS and external partners.
- Maintain good clinical practice, compliance, and ethics; mentor junior staff; may manage a sub-team.
- Lead infrastructure/cross-functional best-practice initiatives; may support Business Development due diligence.
- Participate in scientific societies/consortia (ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, DIA).
Qualifications:
- PharmD or PhD with 8+ years in quantitative field (clinical pharmacology/PK-PD exposure).
- MS with 12+ years in quantitative field (clinical pharmacology/PK-PD exposure).
Required/Preferred Skills:
- Design/analyze/report clinical pharmacology studies; expertise across therapeutic areas/phases/regions.
- Experience scoping/implementing MIDD; integrate PK/PD/efficacy/safety/biomarkers/RWE/RWD for dose selection and trial design.
- Regulatory experience with NDA/CTDs and agency milestone interactions (EoP2, pre-submission, PIP/PWR).
- Strong knowledge of statistics, drug metabolism, pharmacology, toxicology, bioanalysis, and pharma science; benefit-risk evaluation; cross-functional leadership.
Desired Behavioral Competencies:
- Independently execute deliverables; high-quality/efficient delivery; effective cross-functional communication/influence.
Work Mode: Hybrid.
Compensation/Benefits (Boston, MA):
- Base salary range: $177,000.00–$278,080.00; medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid time off, sick time, and up to 120 hours paid vacation for new hires.
Application Instructions:
- No phone calls or recruiters please.