Sr Director, Early Clinical Development, Neuroscience

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The Senior Director sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. This role will focus on earlier stages of Clinical Development, dedicated to initial evaluations of new molecules, biomarkers, and mechanistic hypotheses in humans, with a focus on clinical strategy, and the design, execution, and interpretation of studies to select the most promising drug candidates.

Position Summary / Objective

• Serve as the clinical point of oversight for a matrixed group of physicians in the neuroscience therapeutic area participating in evaluation and clinical development planning for assets within the research pipeline
• Oversee Global Clinical Physicians in a matrixed environment and manage the clinical aspects of Phase 1 trials in the neuroscience therapeutic area
• 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

Early Phase Trials

• Oversees others and may at times serve as an independent Medical Monitor for Phase 1 clinical trials by:
  • Articulating clinical development strategy
  • Analyzing, interpreting, and acting on clinical trial data
• Independently synthesizes and/or contributes to plans (e.g., trial design, development strategy, regulatory strategy) based on emerging data and multi-functional input
• Supervises and participates in the design and development of clinical studies and research plans in support of asset strategy; clinical studies include first-in-human Phase I, biomarker qualification studies, and/or clinical pharmacology studies
• Sets executional priorities and partners with Global Clinical Scientists to support executional delivery of studies

Clinical Development Expertise & Strategy for Research Pipeline Assets

• Oversees matrixed Global Clinical Physicians and participates in the clinical strategy planning for multiple/complex active programs concurrently within the research pipeline
• Accountable for clinical contribution to the development of indication strategy as well as initial clinical development plans
• Provides clinical leadership and disease area expertise into integrated disease area strategies
• Partners closely with KOLs in specific indications
• Liaises with Translational & Discovery Scientists, and Development Teams to define dose, indications, and patient selection (e.g., biomarker qualification and implementation)
• Liaises with other functions (e.g., Thematic Research Centers and Translational Medicine) to prioritize translational objectives in anticipation of development needs
• Ad-Hoc involvement in various departmental or enterprise initiatives (e.g., committees, sub-teams etc.)
• Presents and/or articulates clinical strategy to senior leadership and to support progression of portfolio

Health Authority Interactions

• Serves as primary clinical oversight in regulatory interactions for development projects

Leadership and Matrix Management

• Responsible for supervising the Phase 1 and research based tasks of Global Clinical Physicians and Global Clinical Scientists in the organization who are leading the clinical aspects of Phase 1 trials as well as those who are planning clinical and translational strategy for research pipeline assets; attracting, developing and retaining top talent; ensures appropriate mentoring of Global Clinical Physicians and Global Clinical Scientists
• Given that much of this role will involve supervising team members who are not direct reports, the ability to lead by influence and example in a matrix based model is crucial
• Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct

Degree Requirements

• Advanced degree(s) in relevant field: MD or MD/PhD and deep clinical expertise in neuroscience

Experience Requirements

• 7+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including…