Assistant Director Global External Research Global Medical Affairs
Location: North Chicago, Illinois
Industry: Pharmaceutical / Biotech
The Assistant Director, Global External Research plans and manages overall external the investigator research programs, and establishes consistent practices across all Therapeutic Areas. Plan and manage overall investigator initiated research (IIR) programs across all functional areas within budget, headcount and timelines. Acts as the research operations team for U.S affiliate to ensure tactical execution needs are met.
Key Responsibilities Include:
1.Manages team including performance management, growth planning, professional development as well as succession planning in the team. Provide leadership and guidance to the medical research support staff.
2.Operational chair for cross-functional scientific review committee responsible for evaluation of investigator initiated research proposals. Ensure committee composition and actions are aligned with the process and procedure requirements.
3.Forecast product supply requirements. Work with clinical drug supply management to manage inventories and ensures global shipment of product
4.Monitor the operations related systems and educational needs of internal and external stakeholders to maintain compliance with policies and procedures, as well as extremal healthcare law throughout the process
5.Champions operational excellence to provide continuous improvement of processes and sharing of best practices and participates in efforts to improve agility in research
6.Actively monitor the clinical and regulatory environment within the context of investigator initiated research and translate learning into strategy, policy and process, as needed
7.Ensure US affiliate needs are met for research execution including confidentiality disclosures, contracts, trial management system updates and documentation.
8.Approves study budgets, maintaining financial tracking and approves invoices
1.Minimum of a Bachelor's degree is required, with a preference for science or biomedical discipline
2.Master's degree, advanced education and/or training preferred
3.10-12 years of experience in Pharmaceutical industry.
4.Prior people management experience is required
5.Prior experience in investigator-initiated research and/or clinical study management is required
1.Security Clearance Not Required
2.Visa Candidates Not Considered
3.Base Salary is Competitive
5.Relocation Assistance Not Available
6.Not Overtime Eligible
7.Interview Travel Not Reimbursed
8.10+ to 15 years experience
9.Seniority Level - Mid-Senior
10.Management Experience Is Required
11.Minimum Education is a Bachelor's Degree
12.Willingness to Travel - Occasionally