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

Miltenyi Biotec; United States; Remote; USD 150,000 - 250,000; Full time

Job summary

Join an innovative firm at the forefront of biomedical research as the VP of Medical Affairs, where you'll lead the launch of groundbreaking CAR T-cell therapies. This pivotal role involves developing strategic medical plans, fostering key relationships with KOLs, and ensuring compliance with regulatory standards. You'll build and lead a high-performing team, driving scientific excellence and collaboration across functions. If you're passionate about transforming patient care and ready to make a significant impact in the field of cell and gene therapy, this opportunity is for you. Be part of a mission-driven organization dedicated to revolutionizing medicine.

Qualifications

• 15+ years in Medical Affairs, preferably in oncology or cell therapy.
• Experience launching high-science therapies, especially CAR T-cell.
• Strong understanding of regulatory compliance and medical education.

Responsibilities

• Develop and execute medical plans for CAR T-cell therapy launch.
• Lead a high-performing Medical Affairs team and oversee MSLs.
• Engage with KOLs and ensure compliance with industry regulations.

Skills

Leadership in Medical Affairs

KOL Engagement

Clinical Research

Medical Communications

Real-World Evidence Generation

Strategic Thinking

Cross-Functional Collaboration

Education

MD, PharmD, or PhD in Life Sciences

Job description

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

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. This leader will oversee medical plans, evidence generation, medical information, medical communications, and the field medical team. 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.

This position will report to the Chief Officer, North America Biomedicine.

Essential Duties and Responsibilities:

• Develop and execute the medical plans to support the launch and lifecycle management of the company’s first CAR T-cell therapy.
• Build, lead, and develop a high-performing Medical Affairs team, including Medical Science Liaisons (MSLs), medical communications, and scientific affairs professionals.
• 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.
• Lead scientific engagement efforts, establishing and maintaining strong relationships with KOLs, academic institutions, and professional organizations to educate and advocate for CAR T therapy.
• Oversee the development and execution of medical education, medical communications, and scientific publication plans to ensure the dissemination of high-quality, evidence-based information.
• Guide real-world evidence and health economics outcomes research (HEOR) strategies in partnership with Market Access to support payer engagement and value demonstration.
• Ensure clinical research incorporates HEOR needs and supports evidence generation strategies that address both regulatory and payer requirements.
• Oversee the strategy and management of the MSL team, ensuring effective field engagement and scientific exchange with healthcare providers in preparation for launch.
• Work closely with Clinical Development to provide medical insights that inform clinical trial design, patient selection strategies, and biomarker development.
• Partner with Commercial, Market Access, and Regulatory teams to ensure that medical affairs strategies align with broader corporate objectives and compliance standards.
• Ensure strict adherence to industry regulations (e.g., FDA, OIG, PhRMA, and global regulatory authorities) in all medical affairs activities.
• Collaborate with Finance and Compliance teams to ensure accurate and compliant reporting of medical activities and adherence to transparency requirements.
• 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 described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a variety of facilities. Each person performing this job must have a home office environment, which is temperature controlled. This job requires the person to be mobile to visit customer sites. Due to the travel requirements, this position may be exposed to natural elements of nature. Used research/clinical equipment may be handled in this job and strict SOPs and PPE must be worn.

Miltenyi Biomedicine, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biomedicine, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you joinMiltenyi Biotec,you join a family that is passionate about making a real impact – one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies – transformative methods that mobilize the body’s own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow.

Equal Opportunity Employer
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