Associate Medical Affairs Operations Director

Summary/Job Purpose

The Associate Medical Affairs Operations Director plays an integral role in supporting the Medical Affairs Operations team. This position provides operational and scientific support of key initiatives to ensure their successful implementation. The Associate Medical Affairs Operations Director contributes to key aspects of the investigator sponsored trial (IST) program and is responsible for activities associated with the activation, tracking, and reporting of study-related information. This role provides an outstanding opportunity to work in a cross-functional environment. This role interfaces with Regulatory Affairs, Global Clinical Supply Chain, Drug Safety, Information Technology, Compliance and Legal departments. Strong communication skills, attention to detail, and the ability to learn and master skills are essential to success. Opportunities for direct ownership over key business processes may be provided to outstanding performers.

Essential Duties And Responsibilities

• Provide strategic leadership and tactical management to global medical affairs programs as it relates to research management, process, cross-functional operational integration, and forward-looking operational planning.
• Lead, interact, collaborate and integrate processes with functional area peers within Medical Affairs, Clinical Development, Drug Supply, Regulatory, Translational Research, Compliance and Legal to activate studies in a manner consistent with relevant SOPs and processes.
• Provide operational expertise and support for the Investigator Sponsored Trial (IST) program with functional area oversight to ensure quality of work and appropriate compliance with regulatory requirements.
• Maintain Med. Affairs Operations internal assets/records and develop reports as needed.
• Ensure all IST program records are kept up to date and accessible for team use and audit-readiness.
• Evaluate and execute solutions to address operational unmet needs within Medical Affairs Operations, for example, how to connect forecast drug shipments, data read-outs, milestones and payments with IST System data.
• Assist with the budget negotiation process for Medical Affairs Operations projects, including Fair Market Value (FMV) assessment for all IST budgets and amendments. Facilitate work to define or refine related processes, where necessary.
• Work with Legal Department and business partners to develop and negotiate payment schedules for ISTs and other Medical research projects.
• Review and assist in the writing or revision of department or cross functional process manuals.
• Evaluate and confirm all IST invoices as per company policy and perform payment assessments required for budget reconciliation upon IST closure or IST amendment.
• Support IST activation workflow in accordance with the IST SOP and defined business processes.
• Assist with other duties related to the operations of the IST program, including facilitation and management of cross-functional work-streams.
• Assist with other duties related to the Medical Affairs Operations function.

Supervisory Responsibilities

None

Education/Experience

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

• Bachelors in a scientific discipline or equivalent degree with a minimum of 11 years of relevant clinical, scientific and/or industry medical affairs; or, equivalent combination of education and experience.
• Experience in Oncology strongly preferred.

Experience/The Ideal For Successful Entry Into Job

• Experience working in clinical trial development, research management, and/or investigator-initiated research programs.
• Experience working with a Medical Affairs research program preferred; Familiarity with clinical research terminology required.
• Direct experience