Director​/Sr. Director, Clinical Pharmacology

Director/Sr. Director, Clinical Pharmacology

Our Waltham based client is seeking a dynamic Director/Sr. Director, Clinical Pharmacology to lead the scientific and strategic direction of clinical pharmacology across their development pipeline. This role is pivotal in shaping both early- and late-stage clinical programs, driving dose selection, study design, PK/PD analysis, and quantitative modeling. You’ll collaborate cross-functionally with Clinical Development, Translational Medicine, Data Sciences, DMPK, Regulatory Affairs, Nonclinical Safety, and external partners to ensure scientific rigor and regulatory success.

• Strategy & Leadership
  :
  Define and execute clinical pharmacology plans across Phase 1–3 programs; guide dose exploration and exposure–response strategies.
• Study Design & Analysis
  :
  Lead early-phase studies (SAD/MAD, food-effect, bioavailability, DDI, QTc, renal/hepatic impairment); oversee PK/PD analysis and reporting.
• Modeling & Simulation
  :
  Drive quantitative pharmacology activities including population PK, exposure–response, and PBPK modeling; translate data into actionable recommendations.
• Cross-Functional Collaboration
  :
  Partner with internal teams to align on objectives, contribute to biomarker strategies, and represent clinical pharmacology on governance committees.
• Regulatory Strategy
  :
  Lead clinical pharmacology input for INDs, CTAs, NDAs/BLAs; engage with FDA, EMA, and NMPA on dose selection and modeling strategies.
• Team Leadership
  :
  Build and mentor a high-performing team; oversee CROs and external partners; establish best practices and internal standards.

• Master’s degree in pharmacology, pharmaceutical sciences, biomedical sciences, or related field required;
  PhD preferred.
• 10–15+ years of clinical pharmacology experience in biotech, pharma, or CRO settings.
• Proven expertise in early-phase study design and quantitative pharmacology.
• Strong track record supporting regulatory filings and agency interactions.
• Hands‑on experience with PK/PD analysis and modeling tools.
• Exceptional communication, leadership, and problem‑solving skills.
• Ability to thrive in a fast‑paced, global, high‑growth environment.

• Medical insurance
• Vision insurance
• 401(k)
• Paid maternity leave
• Disability insurance