Stratacuity: Proven Scientific Placement
Director/Sr. Director, Clinical Pharmacology
Stratacuity: Proven Scientific Placement, Waltham, Massachusetts, United States, 02254
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.
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.
Benefits
Medical insurance
Vision insurance
401(k)
Paid maternity leave
Disability insurance
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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.
Benefits
Medical insurance
Vision insurance
401(k)
Paid maternity leave
Disability insurance
#J-18808-Ljbffr