Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

When you join BMS, you are joining a diverse, high-achieving team united by a common mission.

The Clinical Pharmacology, Pharmacometrics, Disposition and Bioanalysis (CPP-DB) team at BMS is responsible for the pharmacology and pharmacometric support for all pipeline assets throughout the clinical development lifecycle. Composed of pharmacologists, pharmacometricians, and mechanistic modelers, this group oversees the pharmacokinetic evaluation, pharmacometric exposure-response evaluation, quantitative systems pharmacology modeling, physiologically based pharmacokinetic modeling and model based meta-analysis of assets covering all platforms of therapies, including small molecules, traditional and complex biologics and next gen cell therapies. All therapeutic areas are supported. The CP&P team interacts with discovery and translational scientists, project leadership, early development, late development and commercial colleagues to optimize dosing, formulation, delivery and combination strategies to enable faster and more effective drug development informed by core scientific principals and data.

Here, you’ll get the chance to grow and thrive through opportunities that are uncommon in scale and scope. You’ll pursue innovative ideas while advancing professionally alongside some of the brightest minds in biopharma.

The CPP-DB Team is seeking a Senior Scientist, Nonclinical DMPK Writer to join their group. This writer will work in partnership with nonclinical DMPK project leads who are responsible for preparation and review of regulatory submission documents and study reports within the CPP-DB department. The applicant will be assigned to work on multiple programs, across therapeutic areas and modalities, including small molecules, large molecules and cell therapies. Success in this role will require a broad scientific knowledge base, excellent organizational and communications skills in addition to the ability to author high quality regulatory documents for health authority submission. This is a great opportunity for the right candidate to be exposed to many aspects of drug development in a fast paced and exciting environment as we bring novel therapeutics to patients.

• With guidance, partner with DMPK and Bioanalytical Leads to author, review and track scientific summaries and regulatory documents and submissions, including: written and tabulated summaries for IND, NDA, and CTD applications to Health Authorities; Investigator Brochures (IBs); regulatory responses; etc.

• Work on multiple projects across all modalities including small molecule, large molecule and cell therapies.

• Team with DMPK and Bioanalytical Leads in addressing Health Authority questions pertaining to nonclinical pharmacokinetics and bioanalytical support of nonclinical and clinical studies.

• Complete regular document updates such as IB, DSUR, ODAR etc.

• As needed, prepare reports for DMPK studies conducted by or on behalf of BMS.

• Be an expert user of the templates for nonclinical documents that are consistent with FDA and ICH guidelines and with electronic submissions guidelines.

• Work with Document publishing and regulatory department to initiate, maintain and contribute to the authoring, review, and approval process for documents within an electronic publishing system.

• Participate in submission team meetings and manage timelines for submissions.

• Attend department meetings as needed to remain aware of upcoming needs for writing support.

• Adhere to departmental and corporate SOPs and work practices.

• Other duties/responsibilities as assigned, which may include particular assignment to large molecule immunogenicity support and leading the authoring of Immunogenicity Risk Assessments in the department.

• BA/BS with 10+ years or MS degree with 8+ years in biology, chemistry or related sciences or 5+ years of scientific writing experience, or related experience; or PhD in biology, chemistry or related sciences with 2+ years of scientific writing experience

• First-hand experience as lead author on writing documents for Pharmacokinetics and Bioanalytical to be submitted to global regulatory agencies such as those listed above

• Strong PC experience: Microsoft Office Suite experience required including Microsoft Word, Excel, and Outlook; Training on in-house document repository system will be provided but experience working with Microsoft specialized templates and style guides for formatting is preferred

• Must be a self-starter who is flexible and adaptable to changing project priorities and work assignments

• Must have strong interpersonal skills, be a team player, be able to self-advocate and willing to work in an environment where individual initiative and accountability are required

• Careful attention to detail and quality are essential

• Excellent scientific written and verbal communication skills required

#li-hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.