Global Medical Lead, Rx to OTC Switch

About the role

Leads global medical strategy for Rx-to-OTC switch programs, including regulatory input, insights, and due diligence for new assets, supporting both global and country/regional teams.

Drives execution of country-specific medical plans across development and lifecycle stages, collaborating cross-functionally and aligning local roadmaps with global strategy.

Mentors and uplifts emerging talent while pushing their own growth and influence.

Embeds sustainability, access, and social impact into every decision.

Models the challenger mindset: questions complexity, acts with integrity, and makes things radically simple.

Helps shape a culture that's ambitious, collaborative, and serious about recognition and belonging.

Responsibilities

• Lead and execute global medical strategies for Rx-to-OTC switch programs in partnership with cross-functional teams (science, regulatory, commercial).
• Serve as medical lead for clinical and behavioral studies (e.g., label comprehension, actual use), ensuring regulatory compliance and high-quality delivery.
• Lead medical input into regulatory interactions and submissions, including health authority meetings and NDA documentation.
• Develop and implement benefit-risk strategies and support regulatory maintenance activities (e.g., PSUR, RMP).
• Drive country/regional medical strategy execution aligned with global switch objectives and local market dynamics.
• Lead external engagement (e.g., KOLs, advisory boards) and publication strategies to support program success.
• Support pipeline growth through medical due diligence and insights on future Rx-to-OTC switch opportunities.

Requirements

• 7+ years in clinical research with medical affairs experience; exposure to Rx-to-OTC switch programs and consumer studies preferred.
• Experience in clinical development and/or medical affairs, including contribution to regulatory submissions (e.g., NDA).
• Background in switch product development and global or regional roles.
• Experience leading clinical and consumer behavior studies relevant to OTC switch.
• Exposure to regulatory/advisory committee meetings and engagement with KOLs/SMEs.
• Proven ability to lead cross-functional projects with strong strategic and analytical skills.
• Strong leadership, communication, and stakeholder engagement capabilities.

Qualifications

Commensurate with experience.

Skills

Strategic thinking, cross-functional collaboration, regulatory expertise, medical knowledge, leadership, communication, stakeholder engagement.

Benefits

Opella is an equal opportunity and affirmative action employer.

Pay

$150,000.00 - $210,000.00

Schedule

Full-time