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.
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.
Acts 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 approves 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 outcome 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 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.
Lead and manage associate medical directors, which have the responsibility for approving donor eligibility and risk assessment for transmission of infectious diseases from medical standpoint.
Continuously review donor eligibility criteria in accordance with FDA and AATB standards to ensure highest quality of donor screening while maximizing access to donors 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 as additional bandwidth to associate medical director.
Approve all event reports related to adverse reactions in recipients.
Provide on-call support to NOCCs.
Manage medical board of trustees meetings and interactions, oversees committee meetings, and follows-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
MD Required
3 - 5 years of Tissue Banking experience
15+ years total with 7 years' experience with managerial responsibilities.
At least 5 years' experience as an MD.
Working conditions for responsibilities are primarily in an office environment, with communication in person, by phone, and email.
Must be willing to be on call 24 hours per day, 7 days a week;
Travel domestic for a total of 60 days each year; and for in person meetings and conference calls extending beyond usual business hours.
MTF Biologics is a mission-driven organization that is dedicated to saving and healing lives by honoring the gift of donated tissue, serving patients, and advancing science.