University Code 32911 University Title Administrator 1, Research University Job Family Research & Innovation ORP Eligible Yes For more information on ORP, visit: Retirement Plans
Recruitment Pool All Applicants Recruitment Type Multi Title Scope of Search Regional Working Title Project Manager Position Number 592120 Is this employee on a H1B Visa? Position Type Staff Job Status Full-Time FLSA Indicator Exempt Employee Group University Employee Department Massey Cancer Center Organizational Overview
At VCU, we Make it Real through learning, research, creativity, service and discovery — the hallmarks of the VCU experience. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work. It’s a place of opportunity, where your success is supported and your career can thrive. VCU offers employees a generous leave package, career paths for advancement, competitive pay, and an opportunity to do mission-driven work.
Position Primary Purpose and General Responsibilities
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.
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 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
Preferred Hiring Standards Required Licenses/ Certifications Anticipated Hiring Range commensurate with experience Application Process/Additional Information Campus MCV and Monroe Park Campus Hours/Week 40 Normal Work Days/Hours M-F 8-5 Job Open Date 03/24/2021 Posting will close on or before Open Until Filled Yes Job Category Is this a restricted position? No Is this position eligible to participate in alternative work arrangements? Yes Sensitive Position No Resource Critical Yes Quick Link https://www.vcujobs.com/postings/104586 Posting Specific Questions
Required fields are indicated with an asterisk (*).
- * Please describe the contribution you have made to at least 3
(Open Ended Question)
- * Describe your experience developing and managing pre-IND
(Open Ended Question)
Required Documents Optional Documents
- Cover Letter/Letter of Application
- Other Document
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