Director, Medical Affairs and Product Launch Operations

Role Summary

Director, Medical Affairs and Product Launch Operations responsible for leading key operational functions within Medical Affairs, including Congress Planning & Logistics, Grants operations, Publications Planning operations, and Medical Information. Develops and implements best practices to deliver on priorities in support of Medical Affairs strategy, operational efficiency, and product launches. Serves as a key member of the Business Operations team spanning Commercial, Medical Affairs, Patient Advocacy, and Access, with flexibility to support related functions as needed.

Responsibilities

• Support development and execution of Medical Affairs strategies and medical plans aligned with objectives, product lifecycle needs, and regulatory requirements.
• Design, implement, and continuously improve Medical Affairs operational processes, tools, training, and governance frameworks.
• Partner cross-functionally with Compliance, Legal, Commercial, Advocacy, R&D, Market Access, and Field Medical to execute medical strategy and optimize workflows.
• Lead metrics definition, tracking, reporting, and continuous improvement initiatives across Medical Affairs activities.
• Drive digital innovation, systems integration, and operational enablement for Medical Affairs functions.
• Lead end-to-end planning and execution of medical congresses, symposia, and scientific meetings, ensuring compliant and impactful engagement.
• Oversee vendors, agencies, budgets, logistics, and cross-functional coordination for congress participation and related activities.
• Manage grants, funding, and sponsorship programs (e.g., IME, IIS, exhibits, charitable donations), ensuring compliance, prioritization, contracting, and timely payment.
• Serve as program director and operational lead for cross-functional product launch execution.

Qualifications

• Required: BA or BS in Health Sciences or related discipline. PhD/MD/MBA/MS is a plus.
• Required: Minimum of 10 years of biotechnology operations experience, with experience in Medical Affairs operations preferred.
• Required: Strong aptitude and interest in science, drug development process and commercialization pathways in biopharma.
• Required: Knowledge of pharmaceutical industry regulations (FDA, EMA, ICH) and compliance frameworks.
• Required: Proven ability to develop and implement operational best practices in a fast-paced environment.
• Required: Excellent project management skills and ability to drive cross-functional collaboration.
• Required: Strong analytical, strategic thinking, and problem-solving skills.
• Required: Ability to communicate effectively with internal and external stakeholders.
• Required: Ability to prioritize and adapt in a fast-paced growth environment.
• Required: Curiosity, strong work ethic, and a sense of humor.

Education

• BA or BS in Health Sciences or related discipline; advanced degrees (PhD/MD/MBA/MS) considered a plus.