Transforming Patients' Lives through Science
We are seeking a highly experienced and visionary leader to serve as the Head of Late Clinical Development Oncology. This critical role will oversee the entire late development oncology portfolio at BMS, leading an organization of physicians at different levels of experience.
The ideal candidate will have significant clinical research and drug development expertise and leadership experience (10 years or greater) in oncology. They will possess a deep understanding of early-stage through late-stage drug development issues and challenges, as well as extensive experience designing and conducting innovative Phase 2 and Phase 3 clinical trials within related areas of focus.
The successful candidate will also have significant successful global drug filing expertise and regulatory interaction experience (i.e., NDA, ODAC, oral explanation, etc.). Additionally, they will have knowledge, experience, and successful professional relationships with external oncology thought leaders.
We offer a unique opportunity for professionals who share our passion for transforming patients' lives through science. Our inclusive culture promotes diversity in clinical trials, and our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.
Key Responsibilities:
* Serving as a talent champion for BMS and building, recruiting, developing, and retaining a world-class organization of oncology and immuno-oncology clinical development professionals
* Creating and articulating a vision for an innovative and expert Clinical Development organization that enables the design and execution of clinical research plans with both speed and rigor across a broad oncology/immune oncology portfolio
* Supervising the development, clinical components of execution, clinical monitoring, interpretation, and analysis of all clinical trials and protocols in late-stage development and life cycle management (with registrational intent)
* Interfacing with key thought leaders and experts in oncology and immuno-oncology drug development
* Managing all clinical components of regulatory documents, including filings for initial registration and LCM indications
* Serving as the organization's senior expert on oncology clinical development and partnering strategically with the Early Clinical Development team to ensure a seamless transition from Phase 1 to Phase 2
* Partnering with key matrix stakeholders to advise the Head of Integrated Oncology on critical development decisions and oncology portfolio management
* Providing strategic insight and clinical functional expertise to our business development group; accountable for clinical development planning and clinical due diligence for all post-proof-concept assets under consideration for in-licensing or acquisition
* Representing BMS in critical discussions with health authorities in the interpretation of clinical data, clinical trial design experiments, and safety and efficacy profiles of our compounds
* Effectively collaborating with global cross-functional matrix leaders within the organization, while supporting and enhancing the matrix structure of Development Teams
* Developing and promoting a workplace culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability
Requirements:
* MD (Board-certified in oncology preferred)
* Significant clinical research and drug development expertise and leadership experience (10 years or greater) in oncology
* Deep understanding of early-stage through late-stage drug development issues and challenges
* Extensive experience designing and conducting innovative Phase 2 and Phase 3 clinical trials within related areas of focus
* Significant successful global drug filing expertise and regulatory interaction experience (i.e., NDA, ODAC, oral explanation, etc.)
* Knowledge, experience, and successful professional relationships with external oncology thought leaders
* Successful experience building, leading, and motivating teams of clinical research professionals, including MDs, PhDs, and/or PharmDs
* Documented success navigating and delivering results within a highly matrixed work environment; effective cross-business unit and divisional collaboration a must (i.e., partnering across all aspects of research, development, and early commercial)
* Global experience and ability to interface with clinical development leaders across Europe, Asia, Latin America, and US is required
* Knowledge or experience in immuno-oncology is desired
* Experience interacting with business development and licensing, particularly helping to evaluate the technical and franchise aspects for potential in-licensing opportunities that shape the oncology strategy is important
Travel: Domestic and international travel required