Manager, Pharmaceutical Affairs 8/24/2016
The University of Chicago
JOB DESCRIPTIONAPPLY The Manager, Pharmaceutical Affairs oversees several areas of operations, including drug distribution, Investigational New Drug (IND) submissions, adverse event review and other issues related to collaborations with oncology research partners.
Responsibilities of the position include, but are not limited to:
1. Supervision and training of the project managers involved in drug distribution. Identify provision of study agent for each protocol. For agents supplied by industry, forecast and monitor supply requirements, develop distribution plan (obtain and review proposals, review budgets, and integrate into overall budgetary plan), review labels and labeling requirements, develop plan for meeting shipping requirements (regulatory documentation) and develop protocol ordering instructions and forms. Responsible for development and maintenance of relevant SOPs.
2. Pharmacovigilance: develop and maintain relevant standard operating procedures (SOPs), review expedited adverse event/IND safety reports, provide sponsor assessment of attribution for Alliance-held INDs to determine if expedited reporting to FDA is required, and submit expedited adverse event/IND safety reports to industry sponsors as required
3. Supervision of IND/IDE management: determining the need for an IND/IDE for a given trial, preparing initial IND submission, and supervising annual IND/IDE reporting. Develop and maintain SOPs for IND management. Recommend responses to FDA protocol review comments, compile responses to FDA, and facilitate FDA-required changes to protocols. Represent the Alliance in discussions and meetings with the FDA.
4. Protocol Development: Review and draft as needed, sections on drug ordering, and expedited adverse event reporting requirements.
5. Respond to questions from industry and Institutional Review Boards (IRBs) regarding drug supply, drug transfers, and assist with questions about informed consent modifications related to risk.
6. Review agreements between the Alliance and research partners for compatibility/consistency with protocols, Alliance policies and procedures and feasibility of deliverables.
7. Serve as a liaison to the Pharmacy Committee and Alliance disease and modality committees to assist in the development of clinical trials, as appropriate.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or status as an individual with disability.
The University of Chicago is an Affirmative Action / Equal Opportunity / Disabled / Veterans Employer.
Job seekers in need of a reasonable accommodation to complete the application process may contact Human Resources by calling 773-834-1841 or by emailing email@example.com with their request.