Bristol Myers Squibb Company

Precision Medicine Technical Lead, Associate Director

Location
Jersey City, NJ, United States
Posted
Aug 30, 2020
Ref
R1526841
Required Education
Masters Degree/MBA
Position Type
Full time
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.

Precision Medicine:

Precision Medicine is part of the Research and Early Development organization in BMS and leads internal and external diagnostic development activities to support multiple disease areas of interest including hematological malignancies, inflammatory disease programs and solid tumor indications. The team will integrate scientific and business insights of multiple functions to provide innovative solutions that will make precision medicine a reality for the patients and physicians we serve.

Summary:

The position will be part of the Precision Medicine group based in Summit, NJ and will be a lead scientist responsible for developing, validating and testing diagnostic assays for use in clinical trials. This role will have key responsibility to act as the precision medicine technical lead in Drug Development Project teams for specific precision medicine programs.

Desired Technical Skills:

  • Ability to lead diagnostic technology and biomarker development projects
  • Strong knowledge of various diagnostic technologies; such as, IHC, ELISAs, Next Generation Sequencing, FISH, RT-PCR, ddPCR and other emerging technologies
  • Experience with CAR-T therapies and their associated assays and safety assessments
  • Experience performing due diligence of vendors, technologies and assays
  • Experience collaborating and/or monitoring clinical trial sites
  • Broad understanding of drug discovery & development
  • Knowledge of biomarker discovery and development and assay development/validation
  • Authoring of precision medicine portions of clinical protocols, drug study reports, regulatory submissions
  • Proven scientific/leadership expertise (working in teams, managing people/projects)
  • Strong verbal and written communication skills
  • Ability to think strategically to find solutions and mitigation strategies to complex problems and then execute them
  • Basic understanding of IP, contracting terms and provisions

Responsibilities:
  • Represents Precision Medicine in Project Team, other cross-functional teams as needed
  • Responsible for delivery of diagnostic programs
  • Responsible for the precision medicine sections of clinical protocols in trials and represents precision medicine plans at key review meetings and plans execution
  • Responsible for technical oversight of external diagnostic programs
  • Creates SOW and interfaces with CRO for execution of services
  • Supports regulatory submissions, regulatory interactions, writes precision medicine sections for regulatory response and answers to regulatory queries.
  • Communicates regularly and prepares and makes presentations within the department and externally as required

Qualifications:
  • Proven track record of development of in vitro diagnostics is a must (Class II and Class III (preferred))
  • Experience participating in regulatory meetings (diagnostic and drug (plus))
  • Significant experience writing, reviewing and overseeing execution of validation protocols
  • Significant experience in reviewing submission documentation for technical accuracy and completeness
  • Extensive experience working with external partners
    • Experience performing due diligence and auditing of vendors and technologies is a plus
  • Proven risk management skills
    • Able to anticipate problems at project level and put mitigation plans into place
  • Extensive experience in clinical development process and validation in an industry setting
  • Extensive knowledge and understanding of ISO13485, GMP and extensive design control understanding a must
  • Ability to manage scientific collaborations and contracted research
  • Proven written and oral communication skills
  • 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:
  • Innovative spirit, thinking and desire to advance precision medicine to find solutions for our patients and increase the value proposition of our pipeline
  • Strong focus on quality and compliance
  • Proven track record of scientific approach to complex problem solving
  • Demonstrated in-depth, scientific-directed thinking
  • Acts as a resource to peers in developing new, innovative approaches to experimental design
  • 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

Requirements & Education:

M.S. with 13+ years relevant experience or 11+ years Ph.D. in molecular biology, biochemistry, chemistry or a related life science. Candidate must be detail-oriented with excellent record keeping and organization skills. Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast paced dynamic environment.

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.