Clinical Development Lead

Profile

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.

Job Title

Clinical Development Lead (CDL)

Division

R&D / Global Drug Development

Functional Area Description

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.

Position Summary / Objective


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)


Position 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


Degree 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


Experience 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)


Key Competency Requirements


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


Travel Required

Domestic and International travel may be required.

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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