Director of Translational Medicine

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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