Clinical Development Lead - Cardiovascular
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.
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 navigating the overall clinical development plan for complex programs that have a large impact on the business Ensures clinical 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)
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, to seek input into the design, execution, analysis and reporting of studies.
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
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 11years of relevant experience
The Senior Director CDL has demonstrated leadership in the design and execution of multiple clinical trials having had 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.
Demonstrated success in formulating clinical development strategy across increasingly complex clinical programs with large impact on the business.
Able to ensure that the clinical program will result in a viable registrational strategy
Demonstrated success in designing and executing multiple clinical trials, with significant experience as a clinical leader.
Has achieved the knowledge base to serve as a a trusted internal expert in the therapeutic area, asset, indication, and clinical development, and is viewed as a peer by external academic collaborators and other KOLs.
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)
Interface across multiple functions to mediate conflict resolution, and champion an organizational culture to promote behaviors that lead to meaningful synergies and superior performance .
In addition the CDL should have all of the following experiences and capabilities:
Expertise in implementing scientific methods to test hypotheses, design, analyze, interpret and report results
Ability to recognize, articulate, and accept calculated risks to make informed decisions
Deep understanding of the fundamentals of protocol development and follow up, including but not limited to study monitoring, data collection and analysis, database cleaning and database lock
Understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements
Comfortable working in a fast-paced environment; ability to support multiple, complex, studies in parallel
Willing to work outside of a traditional functional environment, in a team unified around serving the assets
Willingness and ability to form strong, productive partnerships with external providers/thought leaders
Possess excellent communication skills and experience delivering effective presentations on both technical and non-technical subjects.
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
Minimum 3 years experience as a medical monitor with proven track record designing and overseeing clinical trials, ideally both early and late stage
Experience supervising CRO-driven studies
Experience with health authorities and regulatory submissions
Understanding of the clinical development process, and the role of non-R&D functions: commercial, health outcomes, access, medical
Proven ability to partner effectively with key internal and external stakeholders
Domestic and International travel may be required.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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