Sr Director, Early Clinical Development, Neuroscience

Bristol Myers Squibb • Harvester, MO

2d • $313,200 - $425,060 • Hybrid

About The Position

The Senior Director sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. This role will focus on earlier stages of Clinical Development, dedicated to initial evaluations of new molecules, biomarkers, and mechanistic hypotheses in humans, with a focus on clinical strategy, and the design, execution, and interpretation of studies to select the most promising drug candidates.

Requirements

• Advanced degree(s) in relevant field: MD or MD/PhD and deep clinical expertise in neuroscience
• 7+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable
• 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 other colleagues from Clinical Development to assure a seamless transition into Phase II-III trials

Responsibilities

• Serve as the clinical point of oversight for a matrixed group of physicians in the neuroscience therapeutic area participating in evaluation and clinical development planning for assets within the research pipeline
• Oversee Global Clinical Physicians in a matrixed environment and manage the clinical aspects of Phase 1 trials in the neuroscience therapeutic area
• 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
• Oversees others and may at times serve as an independent Medical Monitor for Phase 1 clinical trials by: Articulating clinical development strategy, Analyzing, interpreting, and acting on clinical trial data, Independently synthesizes and/or contributes to plans (e.g., trial design, development strategy, regulatory strategy) based on emerging data and multi-functional input
• Supervises and participates in the design and development of clinical studies and research plans in support of asset strategy; clinical studies include first-in-human Phase I, biomarker qualification studies, and/or clinical pharmacology studies
• Sets executional priorities and partners with Global Clinical Scientists to support executional delivery of studies
• Oversees matrixed Global Clinical Physicians and participates in the clinical strategy planning for multiple/complex active programs concurrently within the research pipeline
• Accountable for clinical contribution to the development of indication strategy as well as initial clinical development plans
• Provides clinical leadership and disease area expertise into integrated disease area strategies
• Partners closely with KOLs in specific indications
• Liaises with Translational & Discovery Scientists, and Development Teams to define dose, indications, and patient selection (e.g., biomarker qualification and implementation)
• Liaises with other functions (e.g., Thematic Research Centers and Translational Medicine) to 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 oversight in regulatory interactions for development projects
• Responsible for supervising the Phase 1 and research based tasks of Global Clinical Physicians and Global Clinical Scientists in the organization who are leading the clinical aspects of Phase 1 trials as well as those who are planning clinical and translational strategy for research pipeline assets; attracting, developing and retaining top talent; ensures appropriate mentoring of Global Clinical Physicians and Global Clinical Scientists
• Given that much of this role will involve supervising team members who are not direct reports, the ability to lead by influence and example in a matrix based model is crucial
• 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: Director
• Education Level: Ph.D. or professional degree