Additional Information
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Job Description
FUNCTION:
Clinical Pharmacology Sciences
This position is an onsite role that could be located at our Foster City, CA headquarters or our Parsippany, NJ facility.
POSITION OVERVIEW:
With significant independence, you will lead a broad portfolio of multiple, complex clinical pharmacology strategies and studies for an assigned disease or portfolio (7-8 programs) in the Inflammation therapeutic area, spanning first-in-human through approval and post-marketing activities. Working in close partnership with other Clinical Pharmacology Sciences groups and cross-functional R&D partners, you will develop and execute clinical pharmacology strategies and plans, lead or oversee multiple Clinical Pharmacology Study Teams (CPSTs), and routinely represent Clinical Pharmacology in governance forums, leadership discussions, and selected health authority interactions. You will serve as a senior scientific leader with deep expertise across drug development, bringing strategic direction to complex programs while influencing portfolio decisions, key trade-offs, and long-range plans.
EXAMPLE RESPONSIBILITIES:
Lead the design and conduct of a broad portfolio of multiple, complex clinical pharmacology strategies and studies for an assigned disease or portfolio in the inflammation therapeutic area.
Author, oversee, and evolve clinical pharmacology strategies and plans, including Clinical Pharmacology Plans (CPPs) in partnership with members responsible for bioanalysis, pharmacometrics, regulatory, clinical development, etc. for assigned products or portfolios
Lead or oversee multiple CPSTs and provide matrix leadership across project teams responsible for the largest and most complex products.
Act as the Clinical Pharmacology lead on highly complex projects and advise leadership teams and steering committees on overall clinical pharmacology strategy, key decision points, trade-offs, and risks.
Provide strategic direction for clinical pharmacology study design, study execution, PK-PD and related analyses, interpretation, and reporting in support of clinical development and regulatory submissions.
Represent Clinical Pharmacology in Product Strategy Teams, governance and decision-making forums, and selected health authority interactions as needed.
Develop and manage resource plans, budgets, priorities, and external support models for the assigned area.
Build and maintain thought leader and external relationships that inform short- and long-range R&D and clinical pharmacology strategies.
Coach senior colleagues and cross-functional partners, and raise standards across projects and teams through clear expectations, strong stakeholder management, and effective matrix leadership.
Identify and lead strategic initiatives that improve methodologies, processes, practices, or ways of working across multiple teams.