At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Position:
Clinical Development Lead Functional Area Description
Clinical Development is a global organization dedicated to the efficient design and execution of innovative drug development clinical programs that deliver meaningful new treatment options to patients.
Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials through the combination of strong scientific and clinical expertise and strategic leadership to ensure safe and effective use of BMS products.
A CDL is a scientific and clinical leader who serves as the clinical point of accountability of the Development Team and responsible for the overall clinical development plan for an asset or assets in one or more indications/tumor types. Integrates input from Clinical Trial Physicians (CTPs), Clinical Scientists (CSs), statistics, regulatory, operations, safety, outcomes research, medical, commercial, translational medicine, and other experts both internal and external to BMS. Ensures that studies are aligned with target label indications and are properly designed and conducted to meet regulatory, quality, medical and access goals.
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. Position Summary / Objective
- Serves as a manager to Clinical Trial Physicians (CTPs).
- Serves as the Primary Clinical representative for the relevant asset and/or indication(s) on the Development Teams.
- Is expected to be able to represent Clinical Development in both internal and external forums as the consulted authority for the disease area, including within BD function.
- Partner pro-actively with the Clinical Scientists, Early Clinical Program Leads as well as other GDD Clinical Development Leads.
- 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 CSs 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.
- 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
- Partners with GPV&E 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 GCO/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
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. Experience Requirements
Key Competency Requirements
- 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.
Domestic & International travel may be required / occasionally
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.