Director, Quantitative Clinical Pharmacology (QCP) Lead
Takeda
August 30, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Clinical Research and Development
POSITION OBJECTIVES
Lead Quantitative Clinical Pharmacology (QCP) strategy and Model-Informed Drug Development (MIDD) across multiple drug development projects (from pre-FIH through lifecycle management).
RESPONSIBILITIES / POSITION ACCOUNTABILITIES
- Provide scientific/strategic leadership as Global or Regional Clinical Pharmacology Lead; draft and execute clinical pharmacology plans with M&S integration.
- Enable MIDD using modeling/simulation approaches (e.g., QSP, MBMA) to support internal decisions and regulatory interactions.
- Represent Clinical Pharmacology to global/regional regulatory agencies; prepare clinical pharmacology summary documents for submissions.
- Oversee and/or perform PK/PD and pharmacometric analyses; interpret PK/PD data with DQS and external partners.
- Maintain high standards for GCP, compliance, and ethics; mentor junior staff; act as cross-functional leader and may manage a sub-team.
- Participate in Business Development due diligence (when requested); lead infrastructure and cross-functional best-practice initiatives.
- Lead cross-industry scientific society/consortium engagement.
QUALIFICATIONS
- PharmD or PhD with 8+ years quantitative experience with exposure to clinical pharmacology/PK-PD.
- MS with 12+ years quantitative experience with exposure to clinical pharmacology/PK-PD.
DESIRED TECHNICAL SKILLS
- Clinical pharmacology study design/analysis/reporting.
- MIDD leadership and integration of multi-source data (PK/PD/efficacy/safety/biomarkers/RWE/RWD) for dose selection and trial design.
- Regulatory submission/approvals experience (NDA/CTD).
- QCP representation at key milestones (e.g., EoP2, pre-submission; pediatric PIP/PWR).
- Knowledge of statistics, drug metabolism, pharmacology, toxicology, bioanalysis, pharmaceutical science.
DESIRED BEHAVIORAL COMPETENCIES
- Independently executes; solves complex issues; communicates/influences cross-functionally; delivers high-quality outcomes; prioritizes commitments.
WORK ARRANGEMENT
- Hybrid.
COMPENSATION & BENEFITS (explicitly stated)
- Eligible for medical/dental/vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
APPLICATION INSTRUCTIONS
- No Phone Calls or Recruiters Please.
Lead Quantitative Clinical Pharmacology (QCP) strategy and Model-Informed Drug Development (MIDD) across multiple drug development projects (from pre-FIH through lifecycle management).
RESPONSIBILITIES / POSITION ACCOUNTABILITIES
- Provide scientific/strategic leadership as Global or Regional Clinical Pharmacology Lead; draft and execute clinical pharmacology plans with M&S integration.
- Enable MIDD using modeling/simulation approaches (e.g., QSP, MBMA) to support internal decisions and regulatory interactions.
- Represent Clinical Pharmacology to global/regional regulatory agencies; prepare clinical pharmacology summary documents for submissions.
- Oversee and/or perform PK/PD and pharmacometric analyses; interpret PK/PD data with DQS and external partners.
- Maintain high standards for GCP, compliance, and ethics; mentor junior staff; act as cross-functional leader and may manage a sub-team.
- Participate in Business Development due diligence (when requested); lead infrastructure and cross-functional best-practice initiatives.
- Lead cross-industry scientific society/consortium engagement.
QUALIFICATIONS
- PharmD or PhD with 8+ years quantitative experience with exposure to clinical pharmacology/PK-PD.
- MS with 12+ years quantitative experience with exposure to clinical pharmacology/PK-PD.
DESIRED TECHNICAL SKILLS
- Clinical pharmacology study design/analysis/reporting.
- MIDD leadership and integration of multi-source data (PK/PD/efficacy/safety/biomarkers/RWE/RWD) for dose selection and trial design.
- Regulatory submission/approvals experience (NDA/CTD).
- QCP representation at key milestones (e.g., EoP2, pre-submission; pediatric PIP/PWR).
- Knowledge of statistics, drug metabolism, pharmacology, toxicology, bioanalysis, pharmaceutical science.
DESIRED BEHAVIORAL COMPETENCIES
- Independently executes; solves complex issues; communicates/influences cross-functionally; delivers high-quality outcomes; prioritizes commitments.
WORK ARRANGEMENT
- Hybrid.
COMPENSATION & BENEFITS (explicitly stated)
- Eligible for medical/dental/vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
APPLICATION INSTRUCTIONS
- No Phone Calls or Recruiters Please.