Senior Director, Clinical Development Lead - Neuroscience

Bristol Myers Squibb•Needham, MA

17d•Hybrid

About The Position

The Clinical Development Lead (CDL) sits within Clinical Development, a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials. CDLs are matrix leaders and managers who lead, develop, motivate, and achieve results through teams; demonstrate a commitment to the development of a resilient attitude, embrace change, and have an unwavering commitment to our People Strategy. Serves as the clinical point of accountability for the Development Team and is responsible for the overall clinical development plan for asset(s) in one or more indication(s)/tumor type(s). Ensures studies are aligned with target label indications and are designed to meet regulatory, quality, medical, and access goals. Serves as a matrix leader to lead, develop, motivate, and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs).

Requirements

MD preferably with appropriate sub-specialty training as appropriate.
PhD, Pharm D, or other health-related scientific field with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge.
At least 9 years of relevant experience.
Demonstrated leadership in the design and execution of multiple clinical trials (e.g., significant experience as a senior clinical leader).
Able to synthesize internal and external data to produce a clinical strategy.
Able to ensure that the clinical program will result in a viable registrational strategy.
Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts.
Able to work with other stakeholders to ensure a robust enterprise-level strategy for asset(s) and indication(s) including early, late, and post-marketing development, as well as awareness of the enterprise disease area portfolio.
Demonstrated, sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent.
Verifiable track record of successful people management and development, or leadership in a matrix team (e.g., mentoring junior colleagues).
Demonstrated 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 Early Development who design and implement first-in-human through proof-of-concept trials and will to assure a seamless transition into late-stage development (Phase II-III trials).
Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables.

Responsibilities

Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication.
Responsible for managing clinical trial physician(s); attracting, developing, and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians.
May serve as CTP as necessary.
Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs. Should work to proactively partner with these roles.
Accountable for clinical content for CSRs, regulatory reports, briefing books, and submission documents.
Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct.
Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within the Business Development function.
Partners with Worldwide Patient Safety physicians in the ongoing review of safety data.
Serves as the (co-)leader of the cross-functional Clinical Development Team.
Provides clinical leadership and disease area expertise into integrated disease area strategies.
Partners closely with KOLs in specific indications.
Serves as Primary Clinical Representative in Regulatory interactions.
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/CS, and raises to DT as needed.
Sets executional priorities and partners with CTP and CS to support executional delivery of studies.
Accountable for top-line data with support of CTP, CS, and Statisticians.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
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.
Flexible time off (unlimited, with manager approval) for US Exempt Employees.
11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees).
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
Unlimited paid sick time (based on eligibility).
Up to 2 paid volunteer days per year (based on eligibility).
Summer hours flexibility (based on eligibility and location).
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
Annual Global Shutdown between Christmas and New Years Day.