What are the responsibilities and job description for the Director/Sr. Director, Clinical Pharmacology position at Stratacuity: Proven Scientific Placement?
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.
Key Responsibilities
- 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.
Qualifications
- 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.