Principal Scientist, Translational Research - CAR T Safety Testing & Reporting

Bristol Myers Squibb•Seattle, WA

10d•Onsite

About The Position

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. 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 . The Cell Therapy Thematic Research Center is one of BMS’s differentiated research platforms delivering innovative therapies to patients. Our mission is to drive leadership in the use of cellular therapies to harness the power of the immune system in treating hematologic malignancies, solid cancers, and autoimmune disease. More specifically, our discovery and translational scientists are focused on developing next-generation, engineered cell-based therapies. The team is committed to discovering and developing transformative therapies that harness the power of the immune system to improve patient outcomes. Position Summary: We are seeking a highly collaborative and detail-oriented scientist with deep expertise in immunology, molecular/cell biology, virology, and/or cell therapy research . In this role, you will lead routine and event-driven safety testing to evaluate risks associated with gene-modified CAR T products in accordance with study protocols and regulatory guidelines. The scope includes early- and late-stage clinical programs as well as post-marketing settings. You will with internal and external stakeholders across multiple assets and platforms. Responsibilities also include providing operational oversight of sample and case tracking and follow-up, o ptimizing testing strategies and assay services, performing data analysis, interpretation, data management and reporting, and supporting responses to regulatory inquiries.

Requirements

Bachelor’s Degree 8+ years of academic and / or industry experience
Or Master’s Degree 6+ years of academic and / or industry experience
Or Ph.D. or equivalent advanced degree in Life Sciences 4+ of academic and / or industry experience

Nice To Haves

Ph.D. with 7+ years of combined postdoc training, clinical research, and industry or biotech experience, with expertise in immunology, molecular/cell biology, virology, and/or cell therapy research.
Exceptional communication, interpersonal, and scientific writing skills, with proven ability to work collaboratively and adaptively in a highly matrixed environment and under tight timelines.
Highly organized, detail-oriented, and scientific driven, with meticulous attention to data tracking and data management.
Solid understanding of regulatory framework and requirements, including experience in drafting and reviewing regulatory documents and developing translational strategies.
Demonstrated ability to build strong relationships with internal and cross-functional stakeholders; CRO experience and knowledge of CLIA/GCLP practices are a plus.

Responsibilities

Execute cell therapy safety testing across assets in alignment with translational strategy, clinical development plan, and medical affair objectives.
Communicate testing strategy, cumulated data, and milestones to cross-functional stakeholders, and engage with technical, scientific, medical/clinical, patient safety, and operational experts to align, revise, and incorporate testing plans.
Track details associated with patient safety events on sample collection and testing for clinical and commercial settings to ensure timely testing and data delivery.
Streamline testing processes and optimize assay services across; drive process improvement with cross-functional dialogue and operational engagement.
Critically review, analyze, and interpret, safety test data, lead communication and reporting go internal and external stakeholders in clinical and commercial settings.
Participate in reporting safety testing data in regulatory documents and contribute to responses to inquiries from health authorities and health care professionals.
Build partnerships in a matrix environment, influence project strategies, and provide expertise in data analysis, reporting and interpretation.
Must be able to set and understand priorities in a fast-paced matrixed environment, must be a team player with a collaborative spirit and work style, and capable of building and maintaining networks within and outside the organization.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

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