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About the Role
Bristol Myers Squibb's 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, and flexibility. This role will transform the lives of patients and the careers of those who do it.
Responsibilities
- 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
- Serve as a Clinical Trial Physician for clinical trials
- Develop and implement the clinical development strategy
- Analyze, interpret, and leverage clinical trial data towards further clinical development
- Serve as principal functional author for Regulatory submissions, Clinical Study Reports, and scientific publications
- Independently synthesize and/or contribute to plans based on emerging data and input from relevant functions
- Design and develop clinical studies and research plans in support of asset strategy
- Manage multiple/complex programs concurrently across clinical lifecycles
- Accountable for clinical contribution to the development of indication strategy
- Partner with Worldwide Patient Safety physicians in the ongoing review and interpretation of safety data
- Provide clinical leadership and disease area expertise into integrated disease area strategies
- Partner closely with KOLs in specific indications
- Evaluate strategic options against a given Target Product Profile (TPP)
- Collaborate with Global Development Operations/Global Compliance Group to develop asset level risk management plan
- Resolve issues with Quality/Clinical Scientists, and bring it to the Clinical Development Team as needed
- Set executional priorities and partner 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
- Liaise with Clinical Scientists, Translational & Discovery Scientists, and Development Teams to define dose and schedule, indications, and patient selection
- Ad-hoc involvement in various departmental or enterprise initiatives
- Present and/or articulate clinical strategy to senior leadership and to support progression of portfolio
- Serve as primary clinical representative in regulatory interactions
- Accountable for clinical contributions to clinical study reports (CSRs), regulatory reports, briefing books and submission documents
- Act as a focal point for defining and establishing relationships with key investigators
- Sit in team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies
- Represent department in business development due diligence and partner alliance management as appropriate
- Sit on JDC/JRC/JSC as appropriate
- May be responsible for managing Clinical Trial Physicians and Clinical Scientists, attracting, developing and retaining top talent
- Ensure appropriate training and mentoring of other physicians and scientists
- Champion a quality-focused mindset and ensure adherence to GCP and compliance obligations for clinical conduct
Requirements
- Extensive experience in clinical development in neuropsychiatric indications is a requirement
- Experience in formulation development in neuropsychiatry is a plus
- 7+ years of relevant experience in translational and/or clinical research in an industry or biotech setting
- Extensive experience in clinical trial design and execution, and development strategy in pharmaceutical industry or biotech
- 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
- Domestic and International travel may be required
Skills
- Clinical development strategy
- Clinical trial data analysis and interpretation
- Regulatory submissions
- Clinical Study Reports
- Scientific publications
- Clinical study design
- Research plans
- Asset strategy
- Indication strategy
- Safety data review and interpretation
- Disease area expertise
- Integrated disease area strategies
- Key Opinion Leader (KOL) engagement
- Target Product Profile (TPP) evaluation
- Risk management planning
- Executional delivery of studies
- Top line data analysis
- Dose and schedule definition
- Patient selection
- Biomarker qualification and implementation
- Clinical strategy presentation
- Regulatory interactions
- Investigator relationship management
- Alliance management
- Business development due diligence
- Matrix leadership
- Talent attraction, development, and retention
- Mentoring
- GCP compliance
Location
- Remote
Work Type
- Full-time
- Remote-by-design
Experience Level
- Senior Director
- 7+ years of relevant experience
Education Level
- MD or MD/PhD
- Deep clinical development expertise in psychiatry
- Fellowship/specialty training in relevant therapeutic area preferred
Benefits
- Comprehensive benefits
About the Company
- Bristol Myers Squibb is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.
- Our purpose-driven culture inspires us to do meaningful work that transforms lives.
- We offer opportunities for growth and a supportive environment that values inclusion, wellbeing, and flexibility.
Equal Opportunity
- We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
- 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.
- Data Protection: We will never request payments, financial information, or social security numbers during our application or recruitment process.
- Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.