Opportunity for an experienced Medical Affairs proffesional to join a global leader in tissue and organ transplantation.
Summary:
This role is fully remote with 25% travel
The Head 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:
- Lead medical policy decisions, advising on patient safety and medical issues to internal teams, clinical partners, and healthcare professionals.
- Oversee medical aspects of the product portfolio, including approval of clinical publications, policies, and procedures related to tissue safety, donor eligibility, and complaint management.
- Ensure compliance with industry standards and regulations through risk reviews, health hazard evaluations, and packaging materials.
- Manage associate medical directors in assessing donor eligibility and infectious disease risks.
- Provide support in reviewing donor records and offer on-call medical support to National Operations Coordination Centers (NOCCs).
- Represent the organization in interactions with regulatory bodies, including the FDA, AATB, and accrediting agencies.
- Develop and execute the strategic vision for medical affairs within the company.
- Direct medical analysis efforts, including recipient outcomes, medical complaints, and tissue risk-benefit communication.
- Lead epidemiological studies on donor risk analysis and approve all adverse reaction event reports.
- Conduct training for medical professionals on donor screening, testing, clinical events, and epidemiological studies while ensuring separation from sales and marketing.
Qualifications:
- 10+ years of experience, with at least 5 years in management and 5 years as an MD/DO.
- U.S. licensed, board-eligible physician
- Expertise in donor eligibility and organ/tissue screening.
- Experience in medical liaison management, clinical study design, and research.
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!