Sr. Manager, Clinical PharmacologyTalent Groups • Waltham, MA, US
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Sr. Manager, Clinical Pharmacology
Talent Groups • Waltham, MA, US
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionPhD / PharmD with 3–4+ years industry experience Strong PK / PD and modeling expertise; Phoenix proficiency required Experience with small molecules, DMPK, ADME, and CNS therapeutics preferred. Knowledge of FDA guidance and direct regulatory interaction experience.
Location : Hybrid – Waltham, MA (3 days onsite)
We are seeking an experienced Clinical Pharmacology Lead to support CNS programs within the Clinical Pharmacology, DMPK, and BA team. The role focuses on dose selection, PK / PD modeling, clinical study support, and regulatory submissions. The ideal candidate brings strong quantitative skills, hands-on modeling experience, and the ability to work independently in a highly matrixed environment.
Key Responsibilities :
- Lead clinical pharmacology strategy for clinical programs.
- Support study design, protocols, analysis plans, and regulatory submissions.
- Conduct / oversee PK (NCA), exposure–response, simulations, and population PK / PD modeling.
- Present model-based strategies to internal teams and regulatory agencies.
- Contribute to IND / NDA documents and FDA interactions.
Requirements :
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Sr Clinical Pharmacology Manager • Waltham, MA, US
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