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Job description
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.
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.