Senior Director, Global Clinical Development, Neuroscience
Bristol-Myers Squibb
- Location
- Princeton NJ, US
- Work model
- On-Site
- Level
- Staff
- H-1B history
- 57 approvals (FY2023)
- Posted
- 18h ago
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.,