Manager, Pharmaceutical Affairs

May 25, 2017
Institution Type
Four-Year Institution
About The Unit: The Alliance for Clinical Trials in Oncology is a National Clinical Trials Network Group sponsored by the National Cancer Institute (NCI). The Alliance Office at the University of Chicago is responsible for Alliance protocol development, regulatory affairs and management of administrative operations for the Alliance.

Unit Job Summary: 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.

Unit Education: Doctoral degree in a field of study relevant to the research being conducted required.

Unit Experience: A minimum of five years of related experience required. (A minimum of seven years of related experience for the BSD) required. Experience facilitating and promoting a research project or contributing to the scientific direction of a research resource (core facility) required. Supervisory experience preferred.

Unit Job Function Competencies: Advanced knowledge in relevant scientific field required. Advanced knowledge of research techniques or methods required. Knowledge of regulatory policies and procedures required. Analytical skills required. Problem-solving skills required. Attention to detail required. Organizational skills required. Excellent verbal and written communication skills required. Ability to work independently and as part of a team required. Excellent interpersonal skills required. Willingness to meet deadlines required. Ability to train others required. Knowledge of Microsoft Office required. Ability to travel to meetings 1-3 times per year required. Experience working with clinical trials in strongly preferred. Experience as a pharmacist is preferred. Oncology experience preferred.

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