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

Miltenyi Biotec Inc; Boston (MA); Remote; USD 150,000 - 250,000; Full time

Job summary

An established industry player is seeking a seasoned leader to spearhead the Medical Affairs team for their groundbreaking CAR T-cell therapy. This pivotal role involves developing strategic medical plans, ensuring regulatory compliance, and fostering relationships with key opinion leaders and healthcare professionals. The ideal candidate will possess extensive experience in oncology and cell therapies, demonstrating a strong ability to lead cross-functional teams and drive innovative solutions. Join a forward-thinking organization committed to making a significant impact in the biomedical field, where your expertise will shape the future of patient care.

Qualifications

• Minimum 15 years of leadership in Medical Affairs, preferably in oncology or cell therapy.
• Proven experience with CAR T-cell therapies and regulatory engagement.

Responsibilities

• Develop and execute medical plans for CAR T-cell therapy launch.
• Build and lead a high-performing Medical Affairs team.

Skills

Leadership in Medical Affairs

Clinical Research

Medical Communications

Regulatory Compliance

KOL Engagement

Cross-Functional Collaboration

Strategic Thinking

Scientific Communication

Education

MD, PharmD, or PhD in Life Sciences

Job description

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 requires working cross-functionally with R&D, Commercial, Market Access, and Regulatory teams to shape the company's CAR T launch strategy and ensure market success.

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 Medical Information function, engaging closely with pharmacovigilance, and ensure timely, accurate, and compliant responses to inquiries from healthcare providers, patients, and internal stakeholders.
4. Lead scientific engagement efforts, establishing and maintaining strong relationships with KOLs, academic institutions, and professional organizations to educate and advocate for CAR T therapy.
5. Oversee the development and execution of medical education, medical 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, ensuring effective field engagement and scientific exchange with healthcare providers in preparation for launch.
9. Collaborate with Clinical Development to inform clinical trial design, patient selection, and biomarker development.
10. Partner with Commercial, Market Access, and Regulatory teams to align medical affairs strategies with corporate objectives and compliance standards.
11. Ensure adherence to industry regulations (e.g., FDA, OIG, PhRMA, global authorities) in all activities.
12. Work with Finance and Compliance teams for accurate, compliant reporting and transparency.
13. Stay informed on scientific, regulatory, and market trends to anticipate challenges and opportunities in the CAR T landscape.

Requirements:

• MD, PharmD, or PhD in relevant life sciences; minimum 15 years of leadership in Medical Affairs, preferably in oncology, cell therapy, gene therapy, or rare diseases.
• Proven experience with high-science, high-touch therapies, especially CAR T-cell or advanced therapies.
• Experience engaging with regulatory and health authorities for product approvals and post-marketing commitments.
• Strong leadership in KOL engagement, scientific exchange, and medical education strategies.
• Ability to build and lead high-performing medical teams.
• Willingness to travel domestically and internationally (30-50%).

Knowledge, Skills & Abilities

• Deep understanding of medical and regulatory compliance (FDA, OIG, PhRMA).
• Expertise in clinical research, medical communications, and real-world evidence.
• Strong cross-functional collaboration skills.
• Executive presence with excellent communication, leadership, and strategic thinking.
• Ability to translate complex scientific concepts into clear insights.
• Experience in launching cell and gene therapies.
• Ability to work in a fast-paced, high-growth environment and drive innovation.

Physical Demands

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

Work Environment

Variety of facilities; home office required; travel to customer sites; exposure to natural elements; handling research/clinical equipment with SOPs and PPE.

Miltenyi Biomedicine, Inc. is an EO Employer and participates in E-Verify. We are passionate about making a real impact through innovative biomedical solutions.

Equal Opportunity Employer. Applicants will be notified of their rights under federal employment laws. Know Your Rights