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

Miltenyi Biotec Inc; California, San Diego (MO, CA); Remote; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a visionary leader in Medical Affairs to spearhead the launch of its groundbreaking CAR T-cell therapy. This role involves developing strategic medical plans, leading a dynamic team, and ensuring compliance with industry regulations. With a focus on innovation, you'll engage with key opinion leaders and drive medical education initiatives. Join a forward-thinking company dedicated to revolutionizing biomedical research and advancing transformative therapies in oncology and beyond. If you have a passion for science and a proven track record in medical leadership, this opportunity is perfect for you.

Qualifications

• 15+ years in Medical Affairs, preferably in oncology, cell, or gene therapy.
• Experience in launching advanced therapies, especially CAR T-cell therapy.

Responsibilities

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

Skills

Medical Affairs

Oncology

Cell Therapy

Gene Therapy

Leadership

Regulatory Engagement

Medical Communications

Real-World Evidence

Cross-Functional Collaboration

Education

MD, PharmD, or PhD

Job description

Job Description

Your Tasks:

• Develop and execute medical plans for the company's first CAR T-cell therapy, supporting launch and lifecycle management.
• Build and lead a high-performing Medical Affairs team, including Medical Science Liaisons (MSLs), medical communications, and scientific professionals.
• Oversee Medical Information, ensuring timely, accurate, and compliant responses to inquiries.
• Lead scientific engagement with KOLs, academic institutions, and professional organizations.
• Manage medical education, communications, and scientific publications to disseminate evidence-based information.
• Guide real-world evidence and HEOR strategies in partnership with Market Access.
• Ensure clinical research supports regulatory and payer evidence needs.
• Oversee MSL team strategy and field engagement.
• Collaborate with Clinical Development for insights on trial design and biomarkers.
• Align medical strategies with Commercial, Market Access, and Regulatory teams.
• Maintain compliance with industry regulations (FDA, OIG, PhRMA, etc.).
• Coordinate with Finance and Compliance for reporting and transparency.
• Stay informed on scientific, regulatory, and market trends in CAR T therapy.

Requirements:

• MD, PharmD, or PhD in relevant sciences; 15+ years in Medical Affairs, preferably in oncology, cell, or gene therapy.
• Experience in launching advanced therapies, with knowledge of CAR T-cell therapy.
• Engagement with regulatory authorities for approvals and post-marketing.
• Strong leadership in KOL engagement and medical education.
• Proven ability to build and lead medical teams.
• Willingness to travel domestically and internationally (30-50%).

Knowledge, Skills & Abilities:

• Deep understanding of compliance (FDA, OIG, PhRMA).
• Expertise in clinical research, medical communications, and real-world evidence.
• Strong cross-functional collaboration skills.
• Executive presence with excellent communication and strategic skills.
• Ability to simplify complex scientific concepts.
• Experience in successful drug launches, especially in cell and gene therapy.
• Adaptability to fast-paced, innovative environments.

Physical Demands: Walking, handling, reaching, talking, hearing, standing, climbing, stooping, lifting up to 50 pounds, and visual acuity are required.

Work Environment: Varied facilities, home office, travel to sites, exposure to natural elements, handling research equipment with SOPs and PPE.

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

Join us in revolutionizing biomedical research and developing transformative cell and gene therapies. For over 30 years, we have contributed to advancements in medicine with over 18,000 solutions that pave the way for future treatments.

Equal Opportunity Employer. Applicants will be notified of rights under federal employment laws. Review the Know Your Rights notice from the Department of Labor.