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

Miltenyi Biotec Inc; Washington (District of Columbia); 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 medical plans, guiding a high-performing team, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in Medical Affairs, particularly in oncology or advanced therapies, and a proven ability to engage with key opinion leaders and regulatory bodies. Join this innovative firm to make a significant impact in the field of biomedical research and contribute to advancing cutting-edge therapies that address critical health challenges.

Qualifications

• 15+ years of experience in Medical Affairs, preferably in oncology or cell therapy.
• Proven track record in launching high-science therapies and engaging with regulatory authorities.

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 medical activities.

Skills

Leadership in Medical Affairs

KOL Engagement

Clinical Research

Medical Communications

Regulatory Compliance

Cross-Functional Collaboration

Strategic Thinking

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. Additionally, they 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.

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

Essential Duties and Responsibilities:

1. Develop and execute the 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 the Medical Information function, engaging closely with pharmacovigilance, and ensuring 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 ensure the dissemination of high-quality, evidence-based information.
6. Guide real-world evidence and health economics outcomes research (HEOR) strategies in partnership with Market Access to support payer engagement and value demonstration.
7. Ensure clinical research incorporates HEOR needs and supports evidence generation strategies that address both regulatory and payer requirements.
8. Oversee the strategy and management of the MSL team, ensuring effective field engagement and scientific exchange with healthcare providers in preparation for launch.
9. Work closely with Clinical Development to provide medical insights that inform clinical trial design, patient selection strategies, and biomarker development.
10. Partner with Commercial, Market Access, and Regulatory teams to ensure that medical affairs strategies align with broader corporate objectives and compliance standards.
11. Ensure strict adherence to industry regulations (e.g., FDA, OIG, PhRMA, and global regulatory authorities) in all medical affairs activities.
12. Collaborate with Finance and Compliance teams to ensure accurate and compliant reporting of medical activities and adherence to transparency requirements.
13. Stay abreast of evolving scientific, regulatory, and market trends to anticipate challenges and opportunities in the CAR T-cell therapy landscape.

Requirements:

• MD, PharmD, or PhD in relevant life sciences discipline required; Minimum of fifteen (15) years of progressive leadership experience in Medical Affairs within the pharmaceutical industry, preferably in oncology, cell therapy, gene therapy, or rare diseases; or a combination of education and experience.
• Proven experience in launching high-science, high-touch therapies, with a strong understanding of CAR T-cell therapy or other advanced therapies.
• Experience engaging with global regulatory and health authorities to support product approvals and post-marketing commitments.
• Strong leadership in KOL engagement, scientific exchange, and medical education strategies.
• Demonstrated ability to build and lead high-performing medical teams, including MSLs, medical information, and scientific affairs professionals.
• Ability to travel domestically and internationally as required (30-50%).

Knowledge, Skills & Abilities

• Deep understanding of medical and regulatory affairs compliance (e.g., FDA, OIG, PhRMA guidelines).
• Expertise in clinical research, medical communications, and real-world evidence generation.
• Strong cross-functional collaboration skills with R&D, Commercial, Market Access, and Regulatory teams.
• Executive presence with excellent communication, leadership, and strategic thinking skills.
• Ability to translate complex scientific concepts into clear, actionable insights for internal and external stakeholders.
• Experience in preparing for and executing a successful drug launch, particularly in the cell and gene therapy space.
• Ability to work in a fast-paced, high-growth environment and drive innovation in medical strategy.

Physical Demands

The physical demands include walking, using hands, reaching, talking, hearing, standing, climbing, balancing, stooping, kneeling, crouching, or crawling. Occasionally lifting/moving up to 50 pounds. Vision requirements include close, color, peripheral, depth perception, and focus adjustment. Must handle multiple tasks in a rapid-paced environment with attention to detail.

Work Environment

This role involves working in various facilities, including a home office environment. Travel to customer sites is required, and exposure to natural elements and research/clinical equipment is possible, with adherence to SOPs and PPE.

Miltenyi Biomedicine, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity and 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. With over 30 years of experience and more than 18,000 solutions, we are dedicated to advancing medicine of tomorrow.