Bristol Myers Squibb Clinical Trial Lead, External Clinical Collaborations, Oncology Clinical Development in Princeton, New Jersey
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
** The Grade/Level of the Role Will be Determined by the Qualifications and Experience of the Chosen Candidate **
Responsibility for execution of clinical collaborations between a BMS development compound and another company’s asset:
Be accountable for the design, execution, and analyses of appropriate clinical trials to test scientific hypotheses and enable further development of combinations.
Lead individual collaborations, including managing input from other members of the Matrix team (Clinical Operations, Regulatory, Translational Medicine, GBS and Clinical Pharmacology)
Implementation of clinical collaboration once agreement executed.
Monitor progress of combination trials with BMS assets under clinical collaborations, and analyze and report ongoing progress and outcomes within his/her scope to I-O Development teams and Governance bodies
In collaboration with GRS and GPVE, monitor safety of collaboration trials and prepare regulatory documents as needed
Work with publications and medical to develop publication plans for each collaboration and lead authoring and review of abstracts, presentations, and manuscripts
Active contributor on Business Development (BD) and External engagement activities:
Represent Clinical Oncology at select Bio and scientific conference meetings with external companies
Together with Alliance Management, establish strong partnership and interfaces with existing collaboration
Together with BD Search and Evaluation, evaluate incoming clinical collaboration proposals and participate in active searches for collaboration partners to address areas of strategic importance
Participate in clinical contributions for due diligences, M&A analyses, and clinical development plan (CDP) generation Work closely with key BD partners (Alliance Management, Finance, S&E, etc.) to ensure execution and overall quality of External Collaborations and related relationships.
Represent Oncology Clinical Development in both internal and external forums.
Be familiar with and potentially contribute to the development plans of programs within assigned FDT(s) and their current statuses
Assess, navigate and integrate inputs from key internal disciplines and stakeholders, especially functional and clinical Program Leads.
Participate in internal cross-functional working groups
May also provide medical and scientific expertise to BMS colleagues in drug discovery, labeling, regulatory, outcomes research, and marketing/commercial departments.
Desired Background and Experience
Substantial clinical research experience (relevant academic research experience could potentially substitute)
Has a 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
Has a history of handling multiple, complex, studies in parallel
Has a history of prior meaningful participation in regulatory submissions
Has a history of strong interactions with thought leaders
Has a history of successful external stakeholders management
Proven ability to work within and potentially lead a matrix team
Performs as an individual contributor
MD preferably with a background in clinical oncology; PhD, Pharm D or other health related scientific field with a deep understanding and direct experience in oncology clinical development. At least 6years of relevant experience.
This position will be based in the Princeton, NJ area.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.