M2M Assistant Director

Position Primary Purpose and General ResponsibilitiesMassey 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, drugs and biologics manufacture (GMP), pre-IND meetings and all other interactions with FDA. In collaboration with MCC members, collect, collate, organize, prepare and submit pre-IND and IND applications to the FDA.
Other duties include:

• Serve as a liaison between basic research faculty and clinical faculty when a project is potentially moving from bench to bedside. Provide advice to MCC members on the drug development pipeline from initial laboratory research through an IND application filing.
• In collaboration with MCC members, establish a drug/biologic development plan for each project to include a timeline and milestones. Define and monitor at all stages development key next steps and the corresponding go/no go decisions.
• Prioritize, in consultation with the M2M committee, the various M2M projects. Assist M2M project leaders to prepare written reports and oral presentations to MCC M2M committee.
• In collaboration with MCC members and VCU Purchasing, write statements of work and contract specifications to solicit and procure contracts with contract research organizations (CRO) to conduct needed studies and manufacture drug. Be responsible for CRO contract negotiations making sure that the CROs are providing their deliverables in a timely fashion.
• Facilitate interactions with Massey's external consultants as well as with the NCI NExT program
• Coordinate interactions among the Sponsor/Investigator, project team, clinical team, and regulatory team to ensure that the IND application, clinical protocol, informed consent form, investigator's brochure are all harmonized and compliant with all federal, VCU, and MCC regulatory requirements. As clinical studies proceed, work with the above stakeholders to ensure that needed changes to the above documents are reported to the FDA in a timely fashion.
• Work with Massey Office of Research Development and Massey members with writing SBIR and STTR grant applications.
• Manage the M2M pilot project competition. This includes preparing announcements, , scheduling review meeting, preparing materials for the meeting, drafting letters with results and monitoring assigned index for expenditures.
• Assist MCC director and ADs for basic and translational research with identifying funds to finance M2M projects.
• Serve as a liaison between MCC members and VCU Innovation Gateway and VCU Ventures, and assist with invention disclosures, intellectual property protection, MTAs, CDAs, licensing, commercialization, and start-up activity.

Minimum Hiring Standards

• 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 1 approved IND applications
• A minimum of 5 years of experience developing and managing pre-IND studies (eg, target identification and validation, lead development, formulation, , 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
• 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