Sr. Medical Director (Hybrid)

MTF Sr. Medical Director (Hybrid) Edison, New Jersey Apply Now

MTF Biologics processes tissue grafts from human donors that are used in a growing array of clinical applications – positively affecting lives across the globe. As a global nonprofit organization that saves and heals lives by honoring donated gifts and serving patients, we collaborate with the medical, scientific, as well as organ and tissue donation communities.

The Sr. Medical Director leads medical affairs for the organization and is responsible for the overall direction and oversight of programs and activities with medical content, including donor eligibility determination and associate medical director supervision, medical complaint analysis, patient recipient outcomes follow-up, risk assessment on donor infectious disease transmission risk, medical board management, and medical information and science liaison activities.

Responsibilities

• Lead and manage associate medical directors, which have the responsibility for approving donor eligibility and risk assessment for transmission of infectious diseases from a medical standpoint.
• Continuously review donor eligibility criteria in accordance with FDA and AATB standards to ensure the highest quality of donor screening while maximizing access to the donor pool.
• Interact with FDA and other governmental agencies and AATB and accrediting / other standard setting organizations on issues related to donor screening, donor testing, donor eligibility, potential adverse reactions, and other medical-related issues of clinical relevance.
• Review and approve donor records to determine donor eligibility as needed, providing additional bandwidth to associate medical directors.
• Responsible for the ultimate medical policy decisions for the organization, disseminating information to MTF employees, recovery partners, clinical partners, customers, physicians, and other medical professionals on patient safety and medical-related issues.
• Act as the organization's most senior advisor on medical / health-related matters and top authority responsible for the organization's medical information in the product portfolio; review and approve internal policies, procedures, and programs related to tissue and product safety, donor eligibility, complaint management, new process or product development, and other related documents to ensure optimal clinical outcomes and compliance with applicable industry standards and government regulations, including risk reviews, health hazard evaluations, and package inserts.
• Review clinical study designs, summaries, and publications.
• Manage the medical information and science liaison activities, analyze clinical and epidemiological outcomes while serving as clinical scientific peers and resources to foster non-promotional ethical relationships between the organization and the medical community.
• Direct medical analysis, including recipient outcomes, medical complaint analysis, and summary of communication on tissue risks and benefits.
• Responsible for epidemiologic and laboratory studies related to donor risk analysis, as needed.
• Approve all event reports related to adverse reactions in recipients.
• Provide on-call support to NOCCs.
• Manage medical board of trustees meetings and interactions, oversee committee meetings, and follow up on actionable items within or in partnership with MTF.
• Participate in internal and external training activities for physicians, surgeons, and other medical professionals on medical-related topics, including donor screening and testing, clinical adverse events, and epidemiologic studies, while separated from sales and marketing functions.
• Perform additional duties as assigned.

Qualifications

Benefits Information

At MTF Biologics, we provide comprehensive benefits and resources to support our employees' physical, emotional, and financial health.

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