Senior Director, Early Clinical Development (MD) - Neuroscience

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The Senior Director will be the clinical lead to progress multiple early clinical assets from first-in-human through proof-of-concept and will prepare the clinical development plan, design clinical trials and lead the clinical development teams. Extensive experience in early clinical development of neurodegenerative and/or neuropsychiatric indications is a requirement. Demonstrated expertise in basic research related to neurodegeneration and/or neuropsychiatry is a plus.

Functional Area Description

The Early Clinical Development function is part of a global scientific organization dedicated to initial evaluations of new molecules, biomarkers, and mechanistic hypotheses in humans. The group drives early clinical strategy, and the design, execution, and interpretation of studies to select the most promising drug candidates for later development.

Position Summary / Objective

• Serve as the clinical point of accountability for the Development Team and responsible for the overall clinical development plan for asset(s) in one or more indication(s)

• Demonstrate matrix leadership to develop, motivate and achieve results through teams; enable development of a resilient attitude, embrace change and have an unwavering commitment to organizational People Strategy

• Ensure studies are designed to meet regulatory, quality, medical, and access goals

Position Responsibilities

Medical Monitoring

• Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept by

  • Articulating clinical development strategy

  • Analyzing, interpreting, and acting on clinical trial data towards development

  • Serving as principal functional author for Regulatory submissions, study reports, and publications 

• Independently synthesizes and/or contributes to plans (e.g., trial design, development strategy, regulatory strategy) based on merging data and multi-functional input

• Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies

 Clinical Development Expertise & Strategy

• Manages multiple/complex active programs concurrently across early development clinical lifecycles

• Accountable for clinical contribution to the development of indication strategy

• Partners with Worldwide Patient Safety physicians in the ongoing review of safety data

• Provides clinical leadership and disease area expertise into integrated disease area strategies

• Partners closely with KOLs in specific indications

• Evaluates strategic options against a given Target Product Profile (TPP)

• Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/Clinical Scientists, and raises to Development Team as needed

• Sets executional priorities and partners with Clinical Scientists to support executional delivery of studies

• Accountable for top line data with support of Clinical Scientists and Statisticians

• Liaises with Clinical Scientists, Translational & Discovery Scientists, and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)

• Liaises with other functions (e.g., Thematic Research Centers and Translational Medicine) and apply foresight and prioritize translational ob