Director of Translational Medicine job in Gaithersburg, USA

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Job type: Permanent

Discipline: Biological Sciences, Immunology

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Director of Translational Medicine with a pharmaceutical company located in Gaithersburg, MD.

Job Responsibilities:

Develop strategy to incorporate the most appropriate TM approaches into early and late stage clinical studies
Define diagnostic approaches to be incorporated into vaccine studies and assure the outcome and analytic approaches are appropriate
Define humoral, cellular and functional immunologic assays to be used in early and late stage clinical studies
Interface between R&D and Clinical Immunology and external vendors to assure assays are fit-for-purpose and valid for their intended use
Assure the diagnostic and immunologic assays that are used in clinical studies are appropriate for agreed-upon endpoints and objectives of the study
Assure the analytic approach, including data display, SAP, TLFs, are appropriate for the selected assays
Author relevant sections of clinical, regulatory and peer-review documents
Serve as the internal expert on translational medicine approach to be used in our vaccine studies
Responsible for external communication of the diagnostic and immunologic approach and interpretation of results
Oversee vendor qualification, selection, and tech transfer of assays

Skills and Requirements:

Advanced degree (Doctorate, or similar degree) in Life Sciences, Biology, or similar discipline
7 + years experience in infectious disease/vaccine development required with demonstrated experience with assays for diagnosing infectious diseases and measuring humoral, cellular and functional immune responses
Demonstrated experience in communicating and working together collaboratively with key stakeholders in the disease community such as clinicians, researchers, and vendors
Proven ability to thrive in a fast-paced, multidisciplinary environment while remaining flexible, creative, proactive, resourceful and efficient
Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
Excellent understanding of translational medicine, drug development and regulatory issues is desirable
Diplomacy and professionalism, able to command respect from peers, and capable of highly independent work as well as being a team player and role model
Excellent verbal and written communication skills, allowing for an open and effective dialogue throughout the company, and for effectively representing the company externally
Strong problem-solving ability and attention to timelines, detail and quality are critical to success
Highly motivated and results-oriented individual with the flexibility and creativity to excel in and contribute to multiple projects simultaneously in a rapidly growing company
Must have the passion and ability to forge and nurture key partnerships and collaborations with the external scientific community, including academia, governmental organizations, nonprofit organizations and CROs

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at 617-903-7746.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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