Senior Director, Global Clinical Development, Neuroscience

About this role

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us .

The Senior Director Global Clinical Development, Neuroscience will be the main point of contact to prepare the clinical development plan, design clinical trials and lead the clinical development teams. Extensive experience in 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.

The Neuroscience 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 clinical strategy, and the design, execution, and interpretation of studies to select the most promising drug candidates for development.

Position Summary / Objective • Serve as the clinical point of accountability for the Clinical 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 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 program and clinical development teams

  Clinical Development Expertise & Strategy • Manages multiple/complex active programs concurrently across 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 Clinical 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 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 representative in regulatory interactions • Accountable for clinical contributions to clinical study reports (CSRs), regulatory reports, briefing books and submission documents

External Partnerships, Alliances, and Publications • Acts as a focal point for defining and establishing relationships with key investigators • Sits in team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies • Represents department in business development due diligence and partner alliance management as appropriate; sits on JDC/JRC/JSC as appropriate • Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.)

Leadership and Matrix Management • May be responsible for managing Clinical Trial Physicians and Clinical Scientists, attracting, developing and retaining top talent; ensures appropriate training and mentoring of other physicians and scientists • 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 a therapeutic area • Fellowship/specialty training in relevant therapeutic area preferred

Experience Requirements • 7+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting • Extensive experience in clinical trial design and execution, biomarker development, and development strat

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