Responsibilities:
- Develops and leads strategic global medical affairs activities related to PKU to accelerate commercialization in launched markets and support launches in other markets.
- Drives communication and collaboration across regional/local Medical Affairs, GMA enabling functions, and cross-functional teams (e.g., Commercial, Market Access) to execute PKU strategic plans.
- Serves as PKU subject matter expert; partners with medical and commercial training to educate internal/external stakeholders on PKU science and clinical aspects.
- Develops and finalizes global evidence generation plan with regional and country medical heads and GMA enabling functions.
- Plans and leads the Investigator Initiated Studies (IIS) strategy for PKU.
- Builds and manages relationships with PKU KOLs, stakeholders, and healthcare professionals; identifies and engages in scientific exchange with PKU experts.
- Acts as strategic partner to Clinical Development, Commercial Development, and Life-Cycle Management (LCM) teams.
- Represents Global Medical Affairs at international and regional scientific congresses.
- Provides medical input to Marketing for commercial activities related to the therapy.
- Plans and leads PKU publication strategy.
- Supervises medical information processes/services for the PKU indication, ensuring appropriate utilization of Medical Services.
Qualifications:
- Advanced Degree required (PharmD, PhD, or MD) with at least 15 years progressively responsible experience in pharma/biotech or related environment; preferably at least 10 years in medical affairs.
- Prior experience as a Global or Regional Medical Lead (supporting the U.S.) within a rare disease; metabolism experience and leadership across medical affairs functions strongly preferred.
- Experience supporting key markets (including the U.S.).
- Proven leadership progression in medical affairs (strategic and tactical).
- Ability to evaluate medical/scientific literature; develop medical and communication strategies.
- Ability to analyze data and craft a scientific narrative for relevant audiences.
- Track record supporting commercialization of orphan/rare disease and/or specialized drugs.
- In-depth experience with payer organizations.
- Demonstrated ability to lead cross-functional teams and influence without direct authority.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication; ability to communicate complex scientific information clearly to diverse audiences.
- Ability to work independently and collaboratively in a global, fast-paced, matrixed environment.
- Excellent planning/organization/time management; analytical/problem-solving skills; adaptability to changing priorities.
- Fluent in English (verbal and written).
- Expertise on PKU or related inborn errors of metabolism; experience in orphan/rare diseases, neurology and/or genetic disorders; knowledge of U.S. market (payers and KOL interactions).
Travel Requirements:
- 40% global travel.
- Office-based or remote with travel to PTC offices/off-site meetings as needed; based in the U.S. (East-coast).