Clinical Development Leader (CDL)

Drug Dev and Preclinical Studies

icon-location-marker Jersey City - NJ - US
Posted 45 days ago Full_time R1522008

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary

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.

Responsibilities

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

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 the resources to pursue their goals, both at work and in their personal lives.