Sr Director, Early Clinical Development, Neuroscience

About the role

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.

Responsibilities

• 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.

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

• Early Phase Trials:

  • Articulate clinical development strategy.

  • Analyze, interpret, and act on clinical trial data.

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

  • Supervise and participate 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.

  • Set executional priorities and partner with Global Clinical Scientists to support executional delivery of studies.

• Clinical Development Expertise & Strategy for Research Pipeline Assets:

  • Oversee matrixed Global Clinical Physicians and participate 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.

  • Provide clinical leadership and disease area expertise into integrated disease area strategies.

  • Partner closely with KOLs in specific indications.

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

  • Liaise 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.).

  • Present and/or articulate clinical strategy to senior leadership and support progression of portfolio.

• Health Authority Interactions:

  • Serve 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.

  • Absorb and 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.

  • Champion a quality-focused mindset and ensure adherence to GCP and compliance obligations for clinical conduct.

Qualifications

• Advanced degree(s) in relevant field.

• MD or MD/PhD and deep clinical expertise in neuroscience.

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

• Extensive experience in clinical trial design and execution, biomarker development, and development strategy in pharmaceutical industry.

• Deep understanding of pharmaceutical discovery, development and commercialization.

• Track record of mentorship and/or management and/or matrix leadership.

• Demonstrated leadership abilities in a matrix environment.

Skills

• Excellent skills in clinical development strategy including the clinical components of regulatory submission(s).

• External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMSP.

• Partner and interact with other colleagues from Clinical Development to assure a seamless transition into Phase II-III trials.

Benefits

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.