Job Summary

This position is responsible for providing strategic and operational expertise and leadership over the Therapeutic Development team. This position will manage cross-functional operations and will contribute to long term strategy in advancing the company’s drug candidates in clinical development. In addition, this individual will work closely with the Sr. VP of Research to position pre-clinical compounds for IND filing and FIH studies. This position requires experience and knowledge in all aspects and phases of drug development and reports to the EVP &Chief Medical Officer.

Essential Functions and Duties

•This position is of key strategic importance to the Company. The successful candidate will be expected to develop and implement drug development programs across a variety of therapeutic areas. It demands in-depth knowledge of functional areas including drug development regulations, business strategies and a deep understanding of the company’s goals and mission.
•This individual oversees the direction and planning of drug and diagnostic product development and coordinates the therapeutic development team. Each product manager oversees a cross-functional team that is responsible for product development from first-in-human through the clinical development cycle to NDA/BLA or equivalent registration
filing.
•Is also responsible for diagnostic product development, whether as a stand-alone product or in conjunction with a drug candidate.
•Identifies needs for specific projects and programs and coordinates with other area managers to assure successful execution. Assures adequate resources and expertise are available for each product, product manager and cross-functional team.
•Coordinates and collaborates with research, regulatory, medical/clinical affairs business development and other functional areas.
•Identifies any issues that may delay a product or project and recommends appropriate actions.
•Selects, develops, supervises and evaluates personnel to ensure the efficient operation of therapeutic and diagnostic product development.
•Assures accurate timelines and budgets for each product in development.
•Collaborates with internal and external experts to assure smooth transitions for each product through each stage of development.
Qualifications

Education/Experience
•PhD or other advanced degree preferred but not required.

Experience
•12+ years of experience in the diagnostic, pharmaceutical, and/or biotech sectors with a focus on drug development, biomarkers, pharmacogenomics, and/or personalized medicine.
•12+ years of project management experience

Knowledge, Skills and Abilities
•Demonstrated strong leadership capabilities
•Demonstrated ability to interact internally and externally with executive level management
•Demonstrated negotiation skills
•Excellent communication skills; written and verbal

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