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Massey Cancer Center is seeking qualified applicants to manage the development, coordination and implementation of all Massey Molecules to Medicine (M2M) projects at all levels including drug discovery, early preclinical, IND-guided advanced preclinical (both GLP and non-GLP), drugs and biologics manufacture (GMP), pre-IND meetings and all other regulatory interactions with FDA. In collaboration with MCC members, collect, collate, organize, prepare and submit pre-IND and IND applications to the FDA. This position will include providing training, developing project plans, coordinating project meetings, prioritizing projects, writing statements of work, identifying funds, and tracking and monitoring all projects.
Candidates with the following experience and skills are encouraged to apply:
• Ph.D., PharmD, M.D., M.S. or B.S. degree in biology, chemistry, life sciences, or pharmaceutical sciences.
• Substantial contribution to the development of a minimum of 3 approved IND applications
• Expert knowledge of 21CFR Part 300, FDA guidance documents, and ICH guidance documents.
• A minimum of 5 years of experience developing and managing pre-IND studies (eg, target identification, target validation, lead development, formulation, methods validation, ADME, toxicology)
• A minimum of 5 years of experience writing pre-IND meeting requests and IND applications including the following sections: general investigational plan; investigator brochure; chemistry, manufacturing and control information; and pharmacology and toxicology information
• Active pharmaceutical ingredient experience includes small molecules or biologics
• Strong time management and organizational skills with the ability to adjust priorities as needed
• Ability to handle simultaneously multiple projects
• Must be able to work both independently and collaboratively
• Detail oriented with excellent verbal, written, and interpersonal skills