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The Clinical Trial Lead, I&N will be responsible for the day-to-day oversight of the MEG BoW which provides scientific expertise necessary to design and deliver Medical Affairs Sponsored Trials, execute on the ISR book of work, and co-develop Integrated Evidence Plan
The Clinical Trial Lead for assigned asset is responsible for driving the development, tracking, and maintenance of the Integrated Evidence Plan, provide oversight of Investigator Sponsored Research (ISR) Book of Work
Key Responsibilities
Clinical Scientist on assigned MASTs, ensuring quality execution of deliverables for all phases of assigned MASTs (start-up/conduct/closure), through activities such as:
Protocol design concept sheet, Protocol and ICF development
Site-facing activities
CRA training materials
Data quality activities; ensure consistent, quality data review across trial teams
Investigator Meetings, SIVs, Advisory Board, and Study committee (e.g., DMC) activities
Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, regulatory responses)
Develop IEP that reflects asset strategy, market priorities, and medical data generation support in partnership with cross functional teams including (but not limited to) GDD, Translational Development, & HEOR
Develop Areas of Interest based on key open data questions identified in the IEP with market input in collaboration with WWM
Identify ISR studies at risk for failing to meet timelines and negotiate mitigation plans with key internal stakeholders and investigators
Assist in reviews of concepts through RFP process, including providing context for ongoing book of work, area of interest development, and upcoming data read outs
MEG representative at AIMs for assigned asset and AIMs working team lead
Qualifications & Experience
Degree in Life Sciences (MD, PhD, Pharm D, MS, RN, or other scientific field preferred) with at least 2 years’ experience with clinical trial oversight
Demonstrated proficiency in driving and managing company-sponsored clinical trials and leading teams (e.g., Clinical Scientist team lead)
Demonstrated track record of leadership in a complex, matrix environment. Experience delivering successful results in a variety of business situations.
Excellent communication skills and experience with difficult discussions.
Successful track record of leading through influence and working across complex, global organizational matrices
Able to analyze, interpret, and present data
Ability to self-supervise, and act independently to identify/resolve program level issues
Proficient critical thinking, problem-solving, decision-making skills, oral and written communication skills
Strong leadership presence
Commitment to Quality
Adaptable / Flexible
Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally
Promotes a culture of scientific excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality, and effective communication
#LI-Hybrid
New York, New York
Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. The company offers drugs in oncology, immunoscience, cardiovascular, and fibrotic diseases. The company’s products include Opdivo, a biological product for anti-cancer indications; Eliquis, an oral inhibitor targeted at stroke prevention in adult patients with non-valvular atrial fibrillation, and the prevention and treatment of venous thromboembolic disorders; and Orencia, a biological product for adult patients with moderately to severely active RA and prostate-specific antigen, as well as reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis.
It also provides Sprycel, a tyrosine kinase inhibitor for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia; Yervoy, a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma; Empliciti, a humanized monoclonal antibody for the treatment of multiple myeloma; and Baraclude, an oral antiviral agent for the treatment of chronic hepatitis B. In addition, the company offers Reyataz, a protease inhibitor for the treatment of human immunodeficiency virus (HIV) and Evotaz; Sustiva franchise, a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV; and Daklinza NS5A replication complex inhibitor, Sunvepra NS3 protease inhibitor, and Beclabuvir NS5B inhibitor. It sells products to wholesalers, retail pharmacies, hospitals, government entities, and medical profession. It has collaboration agreements with Nektar Therapeutics; Janssen Pharmaceuticals, Inc.; Biocartis Group NV.; and FameWave Ltd.
The company was formerly known as Bristol-Myers Company and changed its name to Bristol-Myers Squibb Company in 1989. Bristol-Myers Squibb Company was founded in 1887 and is headquartered in New York, New York.