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Executive Director, Early Clinical Development, Cardiovascular Diseases job in Summit at Bristol-Myers Squibb

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Executive Director, Early Clinical Development, Cardiovascular Diseases at Bristol-Myers Squibb

Executive Director, Early Clinical Development, Cardiovascular Diseases

Bristol-Myers Squibb Summit, NJ Full-Time

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 DescriptionThe 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

/ ObjectiveThis 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 indicationsThe Executive Director may directly supervise the work of multiple Early Clinical Development physiciansThe 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 assessmentsThe 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 leadershipThe 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 teamPosition



Responsibilities

Medical Monitoring Oversees and/or serves as Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept byArticulating clinical development strategyAnalyzing, interpreting, and acting on Clinical Trial data towards developmentServing as principal functional author for Regulatory submissions, study reports, and publicationsStrategy and ExecutionOversees 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 studiesStrategic 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 inputParticipates and/or sit in governing body of formal protocol review and provide approval as appropriateContributes to overall strategy for specific disease / indications while ensuring an overall portfolio viewLiaises 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 portfolioLeads search and evaluation activities on business development due diligence efforts, and provides advice to strategic transactions groupKey member of Early Clinical Development Leadership Team; chairs forum as requiredChairs departmental Staff Meetings and represents governance meetings on an ad hoc basisBuilds a franchise reputation that attracts innovators to bring their ideas to BMSLeadership and Matrix ManagementMay be responsible for managing Early Clinical Development Physicians, and attracting, developing and retaining top talent; ensures appropriate training and mentoring of Early Clinical Development PhysiciansChampions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conductEstablishes an effective and ethical culture that encourages teamwork, peer review, promotes cooperation and provides a supportive cultureDevelops a culture that values diversity of thought, supports coaching, fosters accountability and integrity, and promotes process excellence and continuous improvementOversees team budget and headcountStakeholder Engagement and CommunicationLiaises 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 needsSignificant 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 portfolioInvolvement 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 appropriateRepresents department in business development due diligence and partner alliance management as appropriate; sits on JDC/JRC/JSC as appropriateAccountable for clinical/technical and decisional quality; oversees accuracy, clarity, and utility of materials and reports in business development recommendations arising from collaborationTrack record of contributions to field (e.g., publications, patents, keynote participation in conferences etc.); leadership/faculty roles within relevant professional/scientific/medical societiesDegree



Requirements

Advanced degree(s) in relevant field: MD or MD/PhD and deep clinical expertise in a therapeutic areaSubspecialty fellowship training in applicable therapeutic area preferredExperience



Requirements

10+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicableExtensive experience in clinical trial design, leadership, and development strategy in pharmaceutical industryComprehensive understanding of pharmaceutical discovery, development and commercializationLeadership 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 submissionsDeep understanding of biology, targets and translational scienceExtensive experience of work with health authorities at all levelsProven differentiated ability to support and manage across the totality of the spectrum including development of registrational and non-registrational trialsProven ability to execute the BMS R&D People Strategy, and lead and develop a matrix teamHighly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through RegulatoryComfortable with cross-functional drug and product development teams and management in a matrix environmentMust be skilled at interacting externally and at speaking engagementsMust be skilled at attracting, developing, and retaining skilled professionalsTravel RequiredDomestic and International travel may be requiredAround 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.Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to [ Email address blocked ] - Click here to apply to Executive Director, Early Clinical Development, Cardiovascular Diseases. Visitcareers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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