Associate Director, Cell Therapy - Late Stage Translational Development

Location
Seattle, WA, United States
Posted
Sep 21, 2020
Ref
R1526679
Required Education
Doctorate/PHD/MD
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.

Translational Research is part of the Research and Early Development organization at Bristol-Myers Squibb and leads early stage clinical, pharmacological and translational research and development activities for the immuno-oncology and cellular therapy pipeline and supports the late stage portfolio for regulatory, translational development and life cycle management of cellular therapies. Translational Development is in the process of organizing a late translational group to support multiple disease areas of interest including multiple myeloma, lymphoma, CLL and other hematological malignancies. This group will integrate scientific and business insights of multiple functions and lead the development and execution of translational strategies as well as hold accountability of the use and presentation of translational data in global regulatory submissions and health authority interactions to maximize the potential of BMS cellular therapies.

The successful candidate will have responsibility for directing the scientific aspects of clinical drug development programs through translational research and correlative studies in cellular therapy. The candidate will be part of the translational group based in Seattle, WA and will lead a group of translational scientists who manage clinical studies and execute translational strategies in multiple myeloma, lymphoma and CLL for approval or life-cycle management. Key responsibilities of this role are to act as liaison across multiple global submission teams and will be accountable for the submission activities and deliverables from translational endpoints as well as to develop and manage execution of translational and correlative strategies with translational scientists, computational biology, and cross-functional disease teams.

Responsibilities and Expectations:
  • In-depth knowledge of fundamentals of immunology, immune oncology, and tumor biology in solid and hematological malignancies
  • Utilization of translational based approaches to develop new concepts and mechanism of action hypotheses identifying distinguishing characteristic of BMS compounds alone and in combination with other therapies
  • Knowledge of biomarker discovery and development: assay development/validation, clinical discovery of biomarkers, MoA research, knowledge of platforms
  • Supervise scientific and technical staff, including oversight and management of CROs and academic collaborators
  • Manage internal projects in cell therapy drug development, including cross-functional collaborations with translational and clinical leads in multiple therapeutic and research areas
  • Guide translational scientists and project team members to critically analyze, interpret, report experimental results; draw appropriate conclusions and design next steps
  • Serve on internal project teams and committees as scientific functional lead
  • Communicate regularly and prepare and make presentations within the department, externally, and to internal governance committees as required.
  • Contribute to the writing of investigator brochures, IND applications, clinical protocols, regulatory annual reports, and other regulatory documents when appropriate
  • Support regulatory submissions, regulatory interactions, write/review translational sections for regulatory response and answer to regulatory queries


Qualifications:
  • PhD or MD with at least 12 years of relevant work experience, including a minimum of 10 years of experience in clinical drug development in an industry setting and experience with regulatory filings
  • Strong background in clinical biomarker discovery and analysis, research tools, platforms and assays with strong knowledge in immunology, tumor biology, and hematologic malignancies desired
  • Excellent communication, managerial, and interpersonal skills evidenced by strong ability to interact with and manage research scientists, project teams, outside collaborators and commercial vendors
  • Ability to work effectively and collaboratively in a highly matrixed organization
  • Competence in analysis and solving of problems, and the ability to prioritize and make tradeoffs to achieve goals
  • Strong written communication capabilities with experience in developing documents such as primary manuscripts/publications/reviews, disease strategies, regulatory submissions, strategic communications
  • Proven scientific/project leadership expertise (working in teams, managing collaborations, people/projects)
  • Detail-oriented with the ability to identify and implement creative solutions


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.