Medical Excellence Manager

Medical Excellence Manager

Sobi

Basel or Remote, Switzerland

Job Description

The Medical Excellence Manager is responsible for managing Investigator Sponsored Studies (ISS), Managed Access Programs (MAP) and Post Trial Access (PTA) Programs.

Key responsibilities include:

• Oversee the ISS review and approval process, including proposal validation, coordination of reviews, and communication of decisions to stakeholders.
• Manage the MAP/PTA review and approval process, including coordination of case reviews, decision documentation, and communication with relevant parties.
• Serve as the global point of contact for ISS and MAP management for designated products, working with cross-functional internal and external stakeholders.
• Maintain comprehensive databases for ISS and MAP/PTA, tracking proposals, studies, and decisions with relevant documentation.
• Facilitate contract development and negotiation between sponsors/requestors and Sobi, collaborating with legal, MPL, and other functions as required.
• Support supply chain set-up in conjunction with Affiliate teams and Sobi Supply Chain for both ISS and MAP/PTA programs.
• Provide regular status updates on ISS and MAP/PTA programs to responsible teams and leadership.
• Monitor milestone payments and report ISS budget to budget owners.
• Coordinate with vendors on the set-up and management of MAP and PTA programs as needed.

Qualifications

The ideal candidate must possess:

• A university degree in Life Sciences or Health Sciences, demonstrating a strong academic foundation in the field.
• A minimum of two years' experience within a pharmaceutical company with experience in Medical Affairs.
• Comprehensive knowledge of the Investigator Sponsored Studies (ISS) and clinical study processes.
• Proven experience in handling managed access or early access programs.
• Superior project management skills, including excellent ability to negotiate effectively and resolve conflicts.
• Exceptional analytical and problem-solving abilities, coupled with a robust customer-oriented mindset, strong individual initiative, superior organizational skills, and the ability to effectively multitask in a demanding environment.
• Highly developed interpersonal skills, coupled with a communicative and adaptable approach, essential for working with diverse stakeholders.