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

Miltenyi Biotec Inc; Baltimore (MD); Remote; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a strategic leader for their Medical Affairs team, focusing on the launch of a groundbreaking CAR T-cell therapy. This role involves developing comprehensive medical plans, engaging with key opinion leaders, and ensuring alignment with regulatory standards. As a pivotal figure in the commercialization process, you will foster collaboration across various departments, guiding the scientific and medical strategies essential for success. If you possess a deep understanding of oncology and a passion for innovative therapies, this opportunity offers a chance to make a significant impact in the field of medicine.

Qualifications

• 15+ years in Medical Affairs leadership, preferably in oncology or cell therapy.
• Experience launching high-science therapies and engaging with KOLs.

Responsibilities

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

Skills

Medical Affairs Leadership

Oncology Knowledge

Cell and Gene Therapy Expertise

Regulatory Compliance

KOL Engagement

Scientific Communication

Team Leadership

Education

MD, PharmD, or PhD in relevant 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 Medical Information functions, 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 evidence-based information.
6. Guide real-world evidence and HEOR strategies in partnership with Market Access to support payer engagement and value demonstration.
7. Ensure clinical research supports HEOR needs and evidence generation strategies addressing regulatory and payer requirements.
8. Manage the MSL team for effective field engagement and scientific exchange.
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. Maintain compliance with industry regulations (FDA, OIG, PhRMA, etc.) in all activities.
12. Work with Finance and Compliance to ensure accurate reporting and transparency.
13. Stay updated on scientific, regulatory, and market trends in CAR T-cell therapy.

Requirements:

1. MD, PharmD, or PhD in relevant sciences; 15+ years in Medical Affairs leadership, preferably in oncology, cell or gene therapy, or rare diseases.
2. Experience launching high-science therapies, with knowledge of CAR T-cell or similar therapies.
3. Experience with global regulatory and health authorities for product approval and post-marketing.
4. Strong leadership in KOL engagement, scientific exchange, and medical education.
5. Proven ability to build and lead medical teams including MSLs and scientific staff.
6. Willingness to travel domestically and internationally (30-50%).

Knowledge, Skills & Abilities

1. Deep understanding of medical and regulatory compliance guidelines.
2. Expertise in clinical research, medical communications, and real-world evidence.
3. Strong collaboration skills across functions.
4. Leadership presence with excellent communication and strategic thinking.
5. Ability to simplify complex scientific concepts for diverse audiences.
6. Experience in successful drug launches in cell and gene therapy.
7. Ability to thrive in a fast-paced, innovative environment.

Physical Demands:

The physical demands include walking, handling, reaching, talking, hearing, standing, climbing, stooping, lifting up to 50 pounds, and visual acuity. Must handle multiple tasks efficiently in a rapid environment.

Work Environment:

Work is performed across various facilities, requiring mobility for site visits, with a home office setup. Travel may expose employees to natural elements and requires adherence to SOPs and PPE.

Miltenyi Biomedicine, Inc. is an EO Employer and participates in E-Verify. We are committed to diversity and inclusion, welcoming applicants from all backgrounds.