Senior Director, Global Clinical Development, Neuroscience

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.

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 strategy in pharmaceutical industry
• 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

Key Competency Requirements

• Excellent skills in clinical development strategy including the clinical components of regulatory submission(s)
• External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS
• Partner and interact with colleagues from across the development lifecycle

Travel Required

• Domestic and International travel may be required

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.

Compensation Overview:

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings athttps://careers.bms.com/benefits

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

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. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [email protected] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1604864 : Senior Director, Global Clinical Development, Neuroscience