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About the Role
Bristol Myers Squibb is a purpose-driven company focused on discovering, developing, and delivering innovative medicines to prevail over serious diseases. We offer meaningful work, growth opportunities, and a supportive environment that values inclusion, wellbeing, and flexibility. This role serves as the Clinical Indication Lead for one or more indications of a given asset, accountable for clinical strategy and execution.
Responsibilities
- Owns and drives clinical development strategy across given asset indications, aligned to overall asset strategy, Target Product Profile (TPP), and relevant disease area strategy.
- May lead the Clinical Development Team(s) for given indication(s) depending on program structure.
- Provides clinical and disease area expertise to integrated disease area and portfolio and therapeutic level strategies.
- Represents Clinical as the internal and external authority for the indication/disease area, including regulatory interactions and Business Development support.
- Engages cross-functionally with internal leaders and partners with external investigators, key opinion leaders, and patient advocacy groups.
- Presents clinical strategy, data, and risk assessments to governance bodies, health authorities, and senior leadership.
- Leads a team of physicians and scientists in the design, execution, analysis, and interpretation of all clinical studies for given asset indication(s).
- Ensures studies meet regulatory, quality, medical, and access objectives and are aligned with target label indications.
- Ensures high quality, timely delivery of innovative protocols and data packages for CSRs and Regulatory Filings; implements quality assurance plans.
- Accountable for clinical content and data quality for CSRs, trial documents, regulatory submissions, briefing books, and publications.
- Oversees trial progress, proactively identifies and mitigates risk, and provides regular status and risk updates to senior management.
- Champions quality, compliance, and GCP adherence across all clinical activities, partnering with Development Operations and Compliance as needed.
- Sets priorities aligned to program objectives and works with Clinical Asset leadership to ensure appropriate budget/resourcing.
- Attracts, develops, and retains top clinical talent through effective leadership, mentoring, and training.
- Fosters a culture of scientific excellence, collaboration, innovation, and accountability.
Requirements
- Advanced degree in Life Sciences required (PhD, PharmD, MS, RN, MD or related field, MD).
- Deep clinical and therapeutic area expertise with advanced knowledge of drug development, competitive landscape, and health authority expectations.
- 8+ years of relevant experience, including leadership in the design and execution of multiple clinical trials.
- Demonstrated success in people leadership and/or matrix leadership roles.
- International and domestic travel required.
Location
- International
- Domestic
Work Type
- Site-Essential
- Site-by-Design
- Field-Based
- Remote-by-Design
Experience Level
- Senior Director
- 8+ years of relevant experience
- Leadership experience
Education Level
- Advanced degree in Life Sciences (PhD, PharmD, MS, RN, MD or related field, MD)
Benefits
- Comprehensive benefits
About the Company
- 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.
Equal Opportunity
- BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
- Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
- Bristol Myers Squibb is Disability Confident – Employer
- BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.