Medical Excellence Manager, ISS and MAP

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

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.

Additional Information

Compensation and Total Rewards at Sobi

At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.

Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as:

• A competitive 401(k) match to support your financial future.
• Tuition and wellness reimbursements to invest in your personal and professional growth.
• A comprehensive medical, dental, and vision package to prioritize your health and well-being.
• Additional recognition awards to celebrate your achievements.

The base salary range for this role is 100,000 – 140,000 USD. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every per