Senior Director, Early Clinical Development (MD) - Neuroscience

Bristol Myers SquibbUxbridge - GBonsiteSalary not postedView the original posting at Bristol Myers Squibb ↗

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Job Description The Senior Director, Global Clinical Development, Neuroscience will own the clinical strategy for one or more neuropsychiatry programs. Extensive experience in clinical development in neuropsychiatric indications is a requirement. Experience in formulation development in 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 teamwork Ensure studies are designed to meet Regulatory, Quality, medical, and access goals Position Responsibilities Medical Monitoring Serves as a Clinical Trial Physician for clinical trials by Developing and implementing the clinical development strategy Analyzing, interpreting, and leveraging clinical trial data towards further clinical development Serving as principal functional author for Regulatory submissions, Clinical Study Reports, and scientific publications Independently synthesizes and/or contributes to plans (e.g., trial design, development strategy, regulatory strategy) based on emerging data and input from relevant functions 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 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 and interpretation 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 brings it to the Clinical Development Team as needed Sets executional priorities and partners with Clinical Scientists and Clinical Trial Physicians 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) 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 est

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