Job Information
Astrix Technology Vice President of Medical Affairs in Middlesex County, New Jersey
Vice President of Medical Affairs
Medical Affairs
Middlesex County, NJ, US
Pay Rate Low: 310000 | Pay Rate High: 320000
- Added - 01/04/2025
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Our client, a global leader dedicated to transforming lives through advancements in tissue and organ donation, transplantation, and groundbreaking research, is seeking a Vice President of Medical Affairs to join their growing team.
Type: Direct hire
Location: Remote (30-40% travel)
Summary:
Lead the organization's medical affairs strategy, overseeing all medical content-related programs, and ensuring compliance with industry standards and regulations.
Provides medical leadership across key functions, including the supervision of the Medical Science Liaison team, medical complaint analysis, recipient outcomes follow-up, and risk assessment for infectious disease transmission.
Oversees associate medical directors responsible for donor eligibility determinations.
Responsibilities:
Serve as the primary medical policy decision-maker, providing guidance on patient safety and medical-related issues to employees, clinical partners, customers, physicians, and other healthcare professionals.
Act as the top medical authority on the organization’s product portfolio, reviewing and approving clinical publications, internal policies, procedures, and programs related to tissue and product safety, donor eligibility, and complaint management.
Oversee risk reviews, health hazard evaluations, and package inserts to ensure compliance with industry standards and government regulations.
Lead and manage associate medical directors in assessing donor eligibility and infectious disease transmission risks.
Provide additional support in reviewing and approving donor records as needed.
Offer on-call medical support to National Operations Coordination Centers (NOCCs).
Represent the organization in interactions with the FDA, government agencies, the American Association of Tissue Banks (AATB), and other accrediting and standard-setting bodies.
Develop and execute the strategic vision for medical affairs within the organization.
Direct medical analysis efforts, including recipient outcomes assessment, medical complaint investigations, and tissue risk-benefit communication.
Lead epidemiological and laboratory studies focused on donor risk analysis.
Approve all event reports related to adverse reactions in recipients.
Participate in internal and external training programs for physicians, surgeons, and medical professionals on donor screening, testing, clinical adverse events, and epidemiological studies - maintaining a clear separation from sales and marketing activities.
Qualifications:
Experience: 15+ years of experience, including at least 7 years in a managerial role. Minimum of 5 years of experience as an MD or DO.
Licensure: U.S. licensed and board-eligible physician; eligible for New Jersey licensure.
Expertise: Experience in donor eligibility assessment and organ/tissue screening.
Medical Liaison & Research: Knowledge of medical liaison management, clinical study design, and participation in research.
Publications: At least one published manuscript as a first or senior author.
Technical Skills: Proficiency in email communication, word processing, and presentation software.
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!
INDBH
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.