VP, Medical Affairs - US Biomedicine - Remote *PC 1473

Miltenyi Biotec Inc; Chicago (IL); Remote; USD 150,000 - 250,000; Full time

Job summary

An established industry player is seeking a dynamic leader to spearhead the medical strategy for their groundbreaking CAR T-cell therapy. This pivotal role involves developing comprehensive medical plans, fostering collaboration across various departments, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in Medical Affairs, particularly in oncology or cell/gene therapy, and will be instrumental in shaping the commercialization strategy for innovative therapies. Join a forward-thinking company dedicated to transforming biomedical research and making a significant impact on patient care.

Qualifications

• 15+ years in Medical Affairs leadership, preferably in oncology.
• Experience launching high-science therapies and CAR T-cell therapy.

Responsibilities

• Develop and execute medical plans for CAR T-cell therapy.
• Build and lead a high-performing Medical Affairs team.
• Ensure compliance with industry regulations.

Skills

Leadership

Medical Affairs

Regulatory Compliance

KOL Engagement

Scientific Communication

Clinical Research

Real-World Evidence

Strategic Thinking

Education

MD, PharmD, or PhD in Life Sciences

Job description

Your Tasks:

This role will be responsible for developing and executing the medical plans for the company's first CAR T-cell therapy, ensuring the generation and communication of high-quality scientific and clinical evidence to support its successful launch. This individual will play a critical role in preparing for commercialization, building key external relationships, and ensuring alignment with regulatory and payer expectations. They will oversee medical plans, evidence generation, medical information, medical communications, and the field medical team. The leader will build and lead a high-performing Medical Affairs team, fostering scientific excellence, collaboration, and patient-centric innovation while ensuring compliance with all regulatory requirements. This position will work cross-functionally with R&D, Commercial, Market Access, and Regulatory teams to shape the company's CAR T launch strategy and ensure its success in the market.

This position reports to the Chief Officer, North America Biomedicine.

Essential Duties and Responsibilities:

1. Develop and execute medical plans to support the launch and lifecycle management of the company's first CAR T-cell therapy.
2. Build, lead, and develop a high-performing Medical Affairs team, including Medical Science Liaisons (MSLs), medical communications, and scientific affairs professionals.
3. Oversee the development and management of Medical Information, ensuring timely, accurate, and compliant responses to inquiries from healthcare providers, patients, and internal stakeholders.
4. Lead scientific engagement efforts with KOLs, academic institutions, and professional organizations to educate and advocate for CAR T therapy.
5. Oversee medical education, communications, and scientific publication plans to disseminate high-quality, evidence-based information.
6. Guide real-world evidence and HEOR strategies in partnership with Market Access to support payer engagement and demonstrate value.
7. Ensure clinical research incorporates HEOR needs and supports evidence generation strategies addressing regulatory and payer requirements.
8. Manage the MSL team for effective field engagement and scientific exchange with healthcare providers.
9. Collaborate with Clinical Development to inform trial design, patient selection, and biomarker development.
10. Partner with Commercial, Market Access, and Regulatory teams to align medical strategies with corporate objectives and compliance standards.
11. Ensure compliance with industry regulations (e.g., FDA, OIG, PhRMA, global authorities).
12. Work with Finance and Compliance to ensure accurate reporting and transparency of medical activities.
13. Stay updated on scientific, regulatory, and market trends in CAR T-cell therapy.

Requirements:

1. MD, PharmD, or PhD in relevant life sciences; minimum 15 years in Medical Affairs leadership in pharma, preferably in oncology or cell/gene therapy.
2. Experience launching high-science therapies, with knowledge of CAR T-cell therapy or similar advanced therapies.
3. Experience with global regulatory and health authority interactions.
4. Strong leadership in KOL engagement, scientific exchange, and medical education.
5. Proven ability to build and lead high-performing medical teams.
6. Ability to travel domestically and internationally (30-50%).

Knowledge, Skills & Abilities

1. Deep understanding of medical and regulatory compliance (FDA, OIG, PhRMA).
2. Expertise in clinical research, medical communications, and real-world evidence.
3. Strong collaboration skills across functions.
4. Excellent communication, leadership, and strategic thinking skills.
5. Ability to simplify complex scientific info for diverse stakeholders.
6. Experience in launching cell and gene therapies successfully.
7. Capacity to thrive in a fast-paced, innovative environment.

Physical Demands:

Regular walking, handling, reaching, talking, hearing; occasional lifting up to 50 pounds; vision requirements; multitasking in a rapid environment.

Work Environment:

Variety of facilities, home office, travel to sites, exposure to natural elements, handling research equipment with SOPs and PPE adherence.

Miltenyi Biomedicine, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity. Participates in E-Verify.

Join us in revolutionizing biomedical research and making a real impact with innovative cell and gene therapies that address diseases like cancer and autoimmune conditions. Over 30 years, we have contributed to transformative medical solutions, with more than 18,000 products supporting the future of medicine.

Equal Opportunity Employer. For more info, see the Know Your Rights notice from the Department of Labor.