Director Non-Clinical Devlopment - Cell Therapy

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Director is a scientific leadership position within the department of Nonclinical Development. The position is based in Seattle, WA at the 400 North Dexter Avenue BMS site. In this role, he/she will be responsible for developing broad nonclinical strategy to advance BMS's internal and external portfolio of cell therapeutic medicines and other novel modalities. The individual will be the primary point of contact for the Immuno-oncology and Cell Therapy leadership teams based in Seattle. Additional responsibilities include management of the onsite cell therapy safety laboratory (2 FTE), which conducts a variety of in vitro experiments including T cell receptor selectivity, nonclinical species binding for CAR-T programs, and off-target assessment of binder. He/she will also be responsible to author toxicology documents, to develop nonclinical development strategies to address clinical, scientific or regulatory concerns, conduct due diligence of potential in-licensing candidates, and to participate in regulatory and industry meetings to shape the development of BMS therapeutic candidates.

Responsibilities will also include, but are not limited to, the following:

Lead nonclinical support of cell-based therapies, chiefly addressing questions around nonclinical safety but also in support of translational medicine and pharmacology concerns.

Contribute to departmental discussions and scientific strategy for developing novel therapeutic candidates/modalities and promote the highest standards of scientific excellence within the department and company.

Represent NCR&D on Project Teams and work cross-functionally with other scientific colleagues including scientists in translational development, discovery and clinical research to develop unique approaches to advancing medicines.

Represent BMS as a thought leader in the cell-based therapeutic space and toxicology in BMS, interact constructively with national regulatory authorities, and collaborate with industry consortia through publications and presentations at national meetings.

Provide scientifically and strategically sound nonclinical development plans to management and project teams. Proactively identify and address issues and liabilities that could impact the development/approval of therapeutic candidates.

Create and critically review protocols, monitor the conduct of studies and participate in the interpretation of study results and preparation of study reports. Lead, plan and execute additional toxicology studies as needed to explore toxicity identified in routine toxicology studies.

Write and critically review regulatory submission documents such as CTD sections for INDs and NDAs, Investigator Brochures, PIPs, briefing books, etc. to support clinical trials and drug registration globally. Participate in discussions with internal development teams and/or regulatory agencies to resolve issues and progress compounds to registration.

Manage and supervise the Cell Therapy Safety Laboratory and ensure timely delivery of high quality program impacting research products.

Lead multi-disciplinary project teams transitioning from discovery to development.

Skills/Knowledge/Experience Required:

Experience and expertise in developing cell-or gene-based therapies

Demonstrable record of scientific impact in toxicology and drug development with emphasis on immunomodulatory programs a plus

Strong leadership and management skills, of both individuals and teams

Experience in senior scientific leadership positions

Critical and creative thinking skills

Adeptness in state of the art in vitro and in vivo toxicological techniques for characterization of toxicity.

Extensive experience in preparing toxicology reports and regulatory submission documents for medicinal products.

Experience in face-to-face interactions with global regulatory agencies.

Expert knowledge and skills in toxicology drug development.

Strong written and verbal communication skills and computer proficiency.

Ability to work collaboratively with colleagues within NCD, in other Departments and on Project Teams.

Thorough understanding of GLP regulations.

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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1524663_EN

Updated: 2020-05-07 00:00:00.000 UTC

Location: Seattle,Washington

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com