Executive Director, Early Clinical Development, Cardiovascular Diseases
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.
Functional Area Description
The Early Clinical Development function is part of a global scientific organization dedicated to initial evaluations of new molecules, biomarkers, and mechanistic hypotheses in humans. The group drives early clinical strategy, and the design, execution, and interpretation of studies to select the most promising drug candidates for later development.
Position Summary / Objective
- This role will include above disease / indication strategy work (i.e. supervising broad Early Clinical Development teams across several Development teams, as well as Disease / Indication Strategy teams etc.)
- The Executive Director will set the Early Clinical Development strategy for assets or indications
- The Executive Director may directly supervise the work of multiple Early Clinical Development physicians
- The role will be foundational in working with teams in R&ED and GDD to support GT2 through GT5 and POC transitions, providing insights into biology, translational elements as well as overall benefit risk assessments
- The role includes support of cross portfolio activities in line with Clinical Excellence, including e.g. Protocol Review Committee, support of Business Development activities and Quality and Compliance leadership
- The role will report directly to the Head of Early Clinical Development, ICF or HOCT and will deputize as required, and will be a core member of the Early Clinical Development, ICF or HOCT executive leadership team
- Oversees and/or serves as Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept by
- Articulating clinical development strategy
- Analyzing, interpreting, and acting on Clinical Trial data towards development
- Serving as principal functional author for Regulatory submissions, study reports, and publications
Strategy and Execution
- Oversees and/or designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies
- Strategic management of multiple/complex active early development programs in partnership with Early Development Program Leadership (EDPL)
- Independently synthesizes and/or contributes to plans (e.g., trial design, development strategy, regulatory strategy) based on merging data and multi-functional input
- Participates and/or sit in governing body of formal protocol review and provide approval as appropriate
- Contributes to overall strategy for specific disease / indications while ensuring an overall portfolio view
- Liaises with leadership and upper management in Clinical Scientists, Discovery and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)
- Presents and/or articulates clinical strategy to senior leadership and to support progression of portfolio
- Leads search and evaluation activities on business development due diligence efforts, and provides advice to strategic transactions group
- Key member of Early Clinical Development Leadership Team; chairs forum as required
- Chairs departmental Staff Meetings and represents governance meetings on an ad hoc basis
- Builds a franchise reputation that attracts innovators to bring their ideas to BMS
Leadership and Matrix Management
- May be responsible for managing Early Clinical Development Physicians, and attracting, developing and retaining top talent; ensures appropriate training and mentoring of Early Clinical Development Physicians
- Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
- Establishes an effective and ethical culture that encourages teamwork, peer review, promotes cooperation and provides a supportive culture
- Develops a culture that values diversity of thought, supports coaching, fosters accountability and integrity, and promotes process excellence and continuous improvement
- Oversees team budget and headcount
Stakeholder Engagement and Communication
- Liaises with leadership and upper management of functions (e.g., Thematic Research Centers (TRCs) and Translational Medicine) and apply foresight and prioritize translational objectives in anticipation of development needs
- Significant contribution and leadership to teams from discovery (e.g., TRCs) through commercialization and/or within department (e.g., line management) and/or via external alliances for development and progression of portfolio
- Involvement or delegated involvement in various departmental or enterprise initiatives (e.g., committees, sub-teams etc.)
- Represents R&ED to board of directors/investor/external forums as appropriate
- Represents department in business development due diligence and partner alliance management as appropriate; sits on JDC/JRC/JSC as appropriate
- Accountable for clinical/technical and decisional quality; oversees accuracy, clarity, and utility of materials and reports in business development recommendations arising from collaboration
- Track record of contributions to field (e.g., publications, patents, keynote participation in conferences etc.); leadership/faculty roles within relevant professional/scientific/medical societies
- Advanced degree(s) in relevant field: MD or MD/PhD and deep clinical expertise in a therapeutic area
- Subspecialty fellowship training in applicable therapeutic area preferred
- 10+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable
- Extensive experience in clinical trial design, leadership, and development strategy in pharmaceutical industry
- Comprehensive understanding of pharmaceutical discovery, development and commercialization
- Leadership experience required (e.g. managed a team, led a cross-functional team or involved in asset level decisions with senior level leaders and governance)
Key Competency Requirements
- Proven track record in managing complex clinical programs leading to regulatory submissions
- Deep understanding of biology, targets and translational science
- Extensive experience of work with health authorities at all levels
- Proven differentiated ability to support and manage across the totality of the spectrum including development of registrational and non-registrational trials
- Proven ability to execute the BMS R&D People Strategy, and lead and develop a matrix team
- Highly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through Regulatory
- Comfortable with cross-functional drug and product development teams and management in a matrix environment
- Must be skilled at interacting externally and at speaking engagements
- Must be skilled at attracting, developing, and retaining skilled professionals
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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