ED, Early Clinical Development, Solid Tumors

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Position: ED, Early Clinical Development, Solid Tumors

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.

• This role will include above asset strategy work (i.e. supervising broad Early Clinical Development teams across several solid tumor asset teams)

• The Executive Director will set the Early Clinical Development strategy for solid tumor oncology assets

• The Executive Director may directly supervise the work of multiple Early Clinical Development physicians

• The role will be foundational in working with teams in Research and Drug Development to provide clinical support from discovery through POC transitions (ID1-ID4), 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 VP of Early Clinical Development and will be a member of the Early Clinical Development HOCT extended leadership team

Medical Monitoring:

• 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 Global Program Leads.

• 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 clinical strategy including dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)

• Presents and/or articulates clinical strategy to senior leadership across the enterprise 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 forums 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

Degree and Experience Requirements:

• Advanced degree(s) in relevant field: MD or MD/PhD and deep clinical expertise in a therapeutic area.

• Subspecialty fellowship training in Medical Oncology 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)

• 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

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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