The Senior Manager, Clinical Pharmacology role sits within Quantitative Clinical Pharmacology and Biosimilar Sciences (QPB), part of Global Early Clinical Development (GEC). This position plays an important role in supporting early clinical development programs by contributing to integrated clinical pharmacology strategies, study design, and data interpretation.
Working under the guidance of experienced leaders, this role operates at the program level, collaborating closely with clinical teams, Pharmacometrics (PMX), and Translational & Precision Medicine (TPM). The position offers a strong opportunity to build depth in clinical pharmacology while progressively developing scientific judgment, independence, and leadership capability.
This role is also expected to help bring modern, data‑driven approaches into day‑to‑day clinical pharmacology work, including the thoughtful use of AI‑enabled analytics and advanced data science tools to enhance efficiency, insight generation, and innovation across QPB and GEC.
This role can be based out of West Chester, PA or Parsippany, NJ and will follow a hybrid schedule.
Job Responsibilities and Duties:
• Support clinical pharmacology activities for assigned programs across the entire development lifespan, contributing to integrated clinical and regulatory strategies aligned with program objectives.
• Contribute to the planning, execution, analysis, and interpretation of clinical pharmacology studies, including first‑in‑human and other Phase 1 trials.
• Contribute to dose selection, dose escalation, and exposure–response understanding by integrating clinical PK/PD data with quantitative insights developed in collaboration with Pharmacometrics.
• Partner with Translational & Precision Medicine colleagues to align biomarkers, mechanistic insights, and translational strategies with early clinical development plans.
• Support preparation of clinical pharmacology content for key documents, including clinical development plans, protocols, investigator brochures, clinical study reports, and regulatory submissions.
• Leverage emerging analytical approaches, including AI‑enabled and advanced data science tools, to improve data interpretation, efficiency, and innovation in clinical pharmacology deliverables.
• Contribute to a collaborative team culture within QPB and GEC, sharing knowledge and continuously developing technical and scientific capabilities.