Senior Director, Global Clinical Development, Neuroscience

Bristol Myers Squibb • Princeton, NJ

4d • $313,200 - $379,524 • Hybrid

About The Position

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.

Requirements

• MD or MD/PhD and deep clinical expertise in a therapeutic area
• 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
• 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

Nice To Haves

• Demonstrated expertise in basic research related to neurodegeneration and/or neuropsychiatry
• Fellowship/specialty training in relevant therapeutic area preferred

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 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
• 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
• 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
• Serves as primary clinical representative in regulatory interactions
• Accountable for clinical contributions to clinical study reports (CSRs), regulatory reports, briefing books and submission documents
• 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
• 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

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off
• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree