Associate Medical Affairs Operations Director

Role Summary

The Associate Medical Affairs Operations Director provides operational and scientific support for key Medical Affairs initiatives, including the Investigator Sponsored Trial (IST) program. This role supports activation, tracking, and reporting of study information and collaborates across Regulatory Affairs, Global Clinical Supply Chain, Drug Safety, IT, Compliance, and Legal.

Responsibilities

• Provide strategic leadership and tactical management to global medical affairs programs related to research management, process, cross-functional operational integration, and forward-looking operational planning
• Lead, interact, collaborate and integrate processes with peers within Medical Affairs, Clinical Development, Drug Supply, Regulatory, Translational Research, Compliance and Legal to activate studies in line with SOPs
• Provide operational expertise and support for the IST program with oversight to ensure quality and regulatory compliance
• Maintain Med. Affairs Operations internal assets/records and develop reports as needed
• Ensure IST program records are up to date and accessible for team use and audit-readiness
• Evaluate and implement solutions to address operational unmet needs within Medical Affairs Operations, e.g., linking forecast drug shipments, data read-outs, milestones and payments with IST data
• Assist with budget negotiations for Medical Affairs Operations projects, including FMV assessments for IST budgets and amendments
• Work with Legal and partners to develop and negotiate payment schedules for ISTs and other Medical research projects
• Review and assist in writing or revision of department or cross-functional process manuals
• Evaluate and confirm IST invoices per policy and perform payment assessments for budget reconciliation on IST closure or amendment
• Support IST activation workflow in accordance with IST SOP and processes
• Assist with other IST operations duties, including cross-functional work-stream facilitation and management
• Assist with other duties related to the Medical Affairs Operations function

Qualifications

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

Experience

• Experience in clinical trial development, research management, and/or investigator-initiated research programs
• Experience with Medical Affairs research programs; familiarity with clinical research terminology
• Direct experience with oncology clinical trials preferred
• Strong analytical and organizational skills with attention to detail
• Strong project management and communication skills
• Ability to provide strategic oversight while managing day-to-day activities across diverse projects
• Ability to work with internal and external customers to implement action plans

Skills

• Exceptional communication skills, both oral and written, with ability to influence stakeholders
• Excellent organizational and time management skills; ability to collaborate with cross-functional teams
• Ability to work independently and in teams
• Change agility and positive attitude, proactive adaptation during rapid change or uncertainty
• Ability to work well under pressure
• Strong analytical skills
• Advanced MS Office skills

Education

• See Qualifications for education requirements

Additional Requirements

• Travel up to 10-20% of the time, including overnight and infrequent weekend travel for congresses/meetings