Senior Director, Global Medical Affairs – Inborn Errors of Metabolism

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the development and execution of launch strategies and preparation activities for all medical affairs deliverables.

• Manage global medical affairs planning and activities through collaboration with US and international teams.

• Collaborate closely with medical excellence and operations teams.

• Formulate and propel the strategic vision for assigned assets.

• Contribute to shaping the target reimbursable product profile.

• Direct the annual data gap analysis and adapt the product data generation plan throughout the asset lifecycle.

• Supervise the global evidence generation review process for Phase IIIB and IV programs, Investigator Sponsored Studies, and non-interventional studies.

• Manage the development of core content and communication strategy plans.

• Create Global Publication Plans.

• Facilitate the public dissemination of product-related data.

• Coordinate medical activities across the US, Europe, Canada, and other international regions.

• Oversee the creation of manuscripts, presentations, symposiums, and posters.

• Act as a thought leader within the therapeutic area and engage with experts for insights on clinical aspects, data generation, interpretation, and dissemination.

• Provide contributions to regulatory documents, including product labeling.

• Establish standard operating procedures and set benchmarks for efficient, accurate, and high-quality medical operations.

• Maintain responsibility for Global Medical Affairs roles focusing on the Inborn Errors of Metabolism team.

⛳️ Requirements

• MD, PhD, or PharmD with outstanding leadership experience in the Medical Affairs sector.

• At least 10 years of experience in Medical Affairs.

• Minimum of 5–7 years of demonstrated supervisory experience.

• Proven ability to lead and inspire teams.

• Prior experience in launching new medications, ideally in rare diseases.

• Extensive knowledge of company products, clinical development processes, commercialization strategies, competition, and the pharmaceutical landscape.

• Established track record of guiding and developing a high-performing team.

• Strong statistical knowledge with the ability to interpret study results and convey findings appropriately.

• Proficient in managing change and influencing stakeholders.

• Excellent communication and interpersonal abilities.

• Capability to influence in a matrixed organizational structure.

• Willingness to travel domestically and internationally up to 30–40% of the time.

• Experience or expertise in rare diseases is strongly preferred.

• Commitment to ensuring compliance with relevant Corporate Policies and Standard Operating Procedures.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-funded basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching program.

• Flexible time off policy.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.