Translational Development at BMS

Translational Development (TD) 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 pipeline. The Translational Development team supports the late-stage portfolio for regulatory, development and life cycle management. Translational Development at BMS has a long-standing history of scientific rigor as evidenced by our peer-reviewed publications, delivery of drug approvals, strong academic collaborations and talent development. Our areas of focus include but are not limited to Hematology, Oncology, Immunology, Cardiovascular and Neuroscience. 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.

Position Summary

Reporting to the Program Management Lead, the incumbent will be part of the late development translational group based in NJ and will be responsible for writing scientific documents including 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 abstracts, posters, manuscript and other scientific communications arising from the group.

Technical Skills

• In-depth understanding of hematological malignancies or solid tumors or Neuroscience disorders especially the clinical landscape, evolving therapy, competitive scenarios
• Strong understanding of clinical, translational and mechanistic data with BMS assets and novel agents
• 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
• Familiarity and working knowledge of CARA, VERITY or other documentation systems
• 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
• Ability to synthesize complex scientific and business problems into strategy and tactics
• Basic understanding of IP, contracting terms and provisions

Responsibilities

• Ensure timely delivery for the TD writing book of work such as pre-clinical reports, and Translational biomarker reports across the disease areas
• In conjunction with TD scientists, establish annual publication goals, 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 TD Program Manager(s) on status of publications
• Supports regulatory submissions, regulatory interactions, writes translational sections for regulatory response and answers to regulatory queries for the TD group in conjunction with biomarker lead(s)
• Collaborate with TD 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 TD 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

Qualifications

• Masters or PhD in Hematology/Oncology/Neuroscience or related field with 6-8 years in industry or an academic setting
• 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

Other Attributes

• 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

#LI-Hybrid

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Madison - Giralda - NJ - US: $170,880 - $207,061Princeton - NJ - US: $170,880 - $207,061

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.