Associate Director, Medical Affairs Operations

Role Summary

Associate Director, Medical Affairs Operations. Lead key operational functions within Medical Affairs, including Congress Planning & Logistics, Grants operations, Publications Planning operations, and Medical Information. Develop and implement best practices to deliver on key priorities in support of the Medical Affairs strategy, operational efficiency, and execution. Serve as a key member of the Business Operations team spanning Commercial, Medical Affairs, Patient Advocacy, and Access, with potential to support related functions as needed.

Responsibilities

• Contribute to the development and implementation of medical strategies, plans, and initiatives to support product lifecycle management and address unmet medical needs.
• Contribute to the development and execution of medical plans, ensuring alignment with overall company objectives and regulatory requirements.
• Develop and implement processes, tools, and training to enhance operational effectiveness within Medical Affairs.
• Establish governance frameworks and ensure alignment with internal policies and external regulations.
• Partner with cross-functional teams to drive medical strategy execution and optimize workflows.
• Lead metrics tracking, reporting, and continuous improvement initiatives across Medical Affairs.
• Support digital innovation and system integration for Medical Affairs functions.
• Lead operational planning and execution of medical congresses, symposia, and scientific meetings.
• Collaborate across functions to oversee logistics for Denali’s participation, including internal meetings, exhibit booths, scientific presentations, and investigator meetings.
• Partner with cross-functional teams to ensure compliant presence and impactful engagement at congresses.
• Manage vendors and agencies supporting congress logistics, ensuring adherence to budgets, timelines, and compliance standards.
• Track and report metrics related to congress participation, insights, and scientific impact.
• Lead the management and oversight of independent medical education grants, investigator-initiated studies, sponsorships, exhibits, and charitable donations.
• Ensure grant processes adhere to internal policies and external compliance requirements.
• Collaborate with Medical Affairs leadership to assess funding priorities and make recommendations.
• Work with multiple functional stakeholders to ensure contracts are executed and paid in a timely manner, including tracking the process and reporting on data.

Qualifications

• BA or BS in Health Sciences or related discipline; PhD/MD/MBA is a plus.
• Around 7 years of biotechnology operations experience with preferred Medical Affairs operations background.
• Strong aptitude and interest in science, drug development process, and commercialization pathways in biopharma.
• Knowledge of pharmaceutical industry regulations (FDA, EMA, ICH) and compliance frameworks.
• Ability to develop and implement operational best practices in a fast-paced environment.
• Excellent project management skills and ability to drive cross-functional collaboration.
• Strong analytical, strategic thinking, and problem-solving skills.
• Effective communication with internal and external stakeholders.
• Ability to prioritize and adapt in a fast-paced growth environment.
• Curiosity, strong work ethic, and a sense of humor.

Skills

• Project management
• Cross-functional collaboration
• Operational governance and compliance
• Data analysis and metrics reporting
• Strategic planning
• Vendor and stakeholder management
• Medical affairs processes and grants administration

Education

• BA/BS in Health Sciences or related field. Doctorate or advanced degree is a plus.

Additional Requirements

• No specific travel or physical requirements were stated as mandatory beyond standard congress participation expectations.