Clinical Development Lead - Neuroscience

Bristol Myers Squibb • Madison, MA

4d • $313,200 - $425,060

About The Position

The Clinical Development Lead sits within Clinical Development, which is 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
• CDL has demonstrated leadership in the design and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader), and exhibits all of the following attributes:
• 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
• CDL has 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)
• CDL has 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 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

• 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.

What This Job Offers

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