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.
Bristol Myers Squibb is an integrated global biopharmaceutical company engaged primarily in the discovery, development, and commercialization of novel therapies in the areas of hematology/oncology, cardiovascular and inflammatory diseases through innovative small molecule, biologicals and cell therapy approaches.
BMS R&D is at a critical and exciting phase of development. As it expands and integrates its portfolio with recent and exciting new acquisitions, there is an opportunity for a science-driven, dynamic and ambitious individual to aid in leading our writing efforts as part of the Hematology Translational Medicine group at our site in Summit, New Jersey.
Hematology Translational Medicine at BMS
Translational Medicine (TM) is part of the Global Research and Early Development organization in BMS and leads mid- to late-stage clinical, pharmacological, and translational research and development activities for the BMS hematology pipeline. The Translational Medicine team supports the late-stage portfolio for regulatory, translational development and life cycle management. Translational Medicine Hematology at BMS has a long-standing history of scientific rigor as evidenced by our peer-reviewed publications, delivery of drug approvals including Revlimid, Pomalyst, Idhifa, Inrebic, Onureg and Reblozyl, strong academic collaborations and talent development. Our areas of focus include but are not limited to multiple myeloma, acute myeloid leukemia/MDS, lymphoma and erythroid disorders. This group integrates scientific learnings from the lab and clinic as well as business insights of multiple functions and leads the development of translational strategies at the franchise level.
Reporting to the Scientific Director / Scientific Senior Director Translational Medicine, the incumbent will be part of the late translational group based in Summit, NJ and will be responsible for writing scientific documents including abstracts, posters, manuscripts, biomarker reports, regulatory documents (eg, non-clinical summaries, translational portions of clinical/pharmacology summaries, briefing books, CSRs, investigator brochures) in conjunction with Translational scientists. This individual will also contribute to communication of key TM data for internal and external presentations related to translational strategies across multiple diseases for approval or life-cycle management. Key responsibilities of this role are to communicate TM data to internal and external audiences effectively and accurately.
- In-depth understanding of hematological malignancies and/or solid tumors especially the clinical landscape, evolving therapy, competitive scenarios
- Strong understanding of clinical, translational and mechanistic data with BMS assets and novel agents in hematology
- Strong background in writing and in communication strategy development, disease and or brand planning, regulatory documents preparation for in-line and late-stage development compounds in disease areas, preferably in hematology
- Understanding of late-stage drug and translational development processes
- Proven ability to work with global disease teams to develop strategies to support life cycle management efforts tailored to regional markets (i.e, US, EU, CAN)
- Strong verbal and written communication skills with experience in developing written documents such as primary manuscripts/publications/reviews, disease strategies, mechanism slides, regulatory submissions, strategic communications, literature/market/pt segment analyses
- Proven scientific/project leadership expertise (working in teams, managing people/projects)
- Ability to synthesize complex scientific and business problems into strategy and tactics
- Basic understanding of IP, contracting terms and provisions
- Provide oversight and ensure timely delivery for the Heme TM publications book of work including manuscripts, congress abstracts/posters/orals, pre-clinical reports, and Translational biomarker reports across areas of focus (eg, multiple myeloma, lymphoma, myeloid, erythroid disorders)
- In conjunction with TM scientists, establish annual publication goals, a pan-heme TM publication plan with priority rankings, and estimated timelines for submission, with focus to ensure all deadlines for regulatory submissions/requests are met. Routinely interact with TM Program Manager(s) on status of Heme publications
- Supports regulatory submissions, regulatory interactions, writes translational sections for regulatory response and answers to regulatory queries for the TM group in conjunction with biomarker lead(s)
- Collaborate with Heme TM scientists and representatives of other functions (eg, Clinical, Non-Clinical Development, Pharmacology, Drug Metabolism & Pharmacokinetics) as needed to execute publications/reports/regulatory documents
- Collaborate with TM Scientists and review data to determine the appropriate tabular and textual formats to ensure clarity, logic and order of presentation. Provide suggestions to improve flow and clarity of narrative and presentation of data
- Engage with Writers and other functions (eg, SciCom, Regulatory, Medical Affairs, Clinical, NCD) outside of TM as needed to stay current on writing SOPs, platforms, resources, and company guidelines
- Communicates regularly and prepares and makes presentations within the department and externally as required
- Participate in recruitment and hiring of new writers as needed
- PhD in Hematology/Oncology or related field with 6-8 years in industry or an academic setting
- Strong background in cancer biology, especially hematological cancers
- Ability to manage scientific collaborations and projects
- Proven written and oral communication skills
- Ability to interpret data and craft key communication points from tables, listings, graphs
- Ability to clearly organize presentations of data into a clear narrative
- Experience with regulatory submissions (eg, IND, NDA/sNDA) required
- Effective team building and teamwork skills with multiple functions
- Detail-oriented with the ability to identify and implement creative solutions
- Ability to prioritize and manage time efficiently
- Some experience with supervision and mentoring of scientific staff is desirable
- Highly detail-oriented with excellent record keeping and organizational skills
- Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced dynamic environment
- Able to anticipate problems at project level
- Proven track record of scientific approach to complex problem solving
- Demonstrate in-depth, scientific-directed, innovative thinking
- Recognizes interrelationships of facts/factors, processes, and systems
- Recognize risk and propose contingency plans
- Independently (or using collaborations) develop scientific direction for assignments
- Recognize cross-functional issues
- Communicates within the larger organization
- Develops constructive relationships across organization to achieve the goals of the function and the business through leadership roles on cross-functional/divisional teams
- Communicates within the larger organization and external community
- Provides expert guidance to multi-disciplinary teams and senior management
Around 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.