VP Medical Affairs

Astrix Inc.; Philadelphia (Philadelphia County); Remote; USD 310,000 - 330,000; Full time

Job summary

An innovative nonprofit organization is seeking a VP of Medical Affairs to lead their medical strategy and ensure regulatory compliance. This fully remote role offers a chance to make a significant impact in the field of tissue and organ donation, overseeing medical content and managing a dedicated team. With approximately 30% travel, you will represent the organization in regulatory interactions and develop the strategic vision for medical affairs. If you are a seasoned medical professional with a passion for saving lives through innovation, this is an exciting opportunity to join a mission-driven team.

Qualifications

• 12+ years of experience with 5 years in management and as an MD or DO.
• Expertise in donor eligibility and organ/tissue screening.

Responsibilities

• Lead medical policy decisions and oversee medical aspects of the product portfolio.
• Manage medical directors in assessing donor eligibility and infectious disease risks.

Skills

Leadership

Medical Strategy

Regulatory Compliance

Risk Assessment

Clinical Study Design

Epidemiological Studies

Education

MD or DO

12+ years of experience

Job description

Philadelphia, PA, US
Pay Rate Low: 310000.00 | Pay Rate High: 330000

Our Client, a global nonprofit organization on the forefront of saving and healing lives through innovations in tissue and organ donation, transplantation, and research, is seeking a VP of Medical Affairs to join their growing team.

Summary:
This role is fully remote with ~30% travel.

The Vice President (VP) of Medical Affairs leads the organization’s medical strategy, overseeing all medical content, ensuring regulatory compliance, and providing leadership across key functions. This includes managing the Medical Science Liaison team, medical complaint analysis, donor eligibility, and risk assessment for infectious disease transmission.

Key Responsibilities:

1. Lead medical policy decisions, advising on patient safety and medical issues to internal teams, clinical partners, and healthcare professionals.
2. Oversee medical aspects of the product portfolio, including approval of clinical publications, policies, and procedures related to tissue safety, donor eligibility, and complaint management.
3. Ensure compliance with industry standards and regulations through risk reviews, health hazard evaluations, and packaging materials.
4. Manage associate medical directors in assessing donor eligibility and infectious disease risks.
5. Provide support in reviewing donor records and offer on-call medical support to National Operations Coordination Centers (NOCCs).
6. Represent the organization in interactions with regulatory bodies, including the FDA, AATB, and accrediting agencies.
7. Develop and execute the strategic vision for medical affairs within the company.
8. Direct medical analysis efforts, including recipient outcomes, medical complaints, and tissue risk-benefit communication.
9. Lead epidemiological studies on donor risk analysis and approve all adverse reaction event reports.
10. Conduct training for medical professionals on donor screening, testing, clinical events, and epidemiological studies while ensuring separation from sales and marketing.

Qualifications:

1. 12+ years of experience, with at least 5 years in management and 5 years as an MD or DO.
2. Expertise in donor eligibility and organ/tissue screening.
3. Experience in medical liaison management, clinical study design, and research.
4. At least one published manuscript as a first or senior author.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!