Vice President, Medical Affairs - Central Laboratory Services

The Vice President, Medical Affairs provides medical consultation for the entire Labcorp Drug Development Central Laboratory Services globally and the global Labcorp Drug Development CLS medical client base. The incumbent is responsible for medical decision-making for the disciplines of the Laboratory.

Additional responsibilities include consulting with Quality Assurance, Regulatory Affairs and Legal relative to clinical diagnostic testing and the provision of medical consultation to Labcorp Drug Development CLS client base through interaction with sponsors, investigators and those units within the corporation that require it.

He/she will actively participate in global medical issues and make the final decision on these issues after consultation with the appropriate regional medical directors.

He/she will hold certificates for all regulatory agencies as appropriate and will assist in interfacing with Regulatory authorities as needed.

The incumbent will work closely with Marketing and Sales to support business development and clients.

This is an office-based role and the incumbent will be based out of our Central Labs in Indianapolis, IN. In addition to a competitive compensation package, a fully assisted relocation package is available.

Essential Job Duties:

• Establish the Medical Affairs strategy in collaboration with the Vice President of Global Testing Services, Scientific and Medical Affairs
• Deliver on the Medical Affairs strategy, drive productivity and ensure on-time delivery of services to internal and external clients
• Ensure continuous professional education and individual development of self and Medical Affairs team members and Pathologists
• Contribute to scientific publications
• Provide medical/pathology/clinical laboratory support to Laboratory operations departments and Investigators sites
• Consult with Quality Assurance to ensure compliance with applicable local and international regulations governing clinical reference laboratories, transport of clinical specimens, and pharmaceutical drug clinical trials
• Assist in the scientific professional growth of laboratory personnel
• Provide expert input in the creation and approval of reference ranges and appropriate test/method selection for a given clinical indication.
• Advise in the development and approval of the technical database, the proprietary clinical trials database, and laboratory information systems
• Participate to routine laboratory results/cases review during week-end rotations and regular business hours as needed
• Key leader in the review and/or approval of new test or service feasibilities
• Interact with Sponsors in protocol review and/or development
• Communicate with clients and clients’ Project Managers to promote project schedule adherence within laboratory operations and meet high quality standards
• Participate in business development visits to current and potential clients as required
• Collaborate with business development in review, writing, presentation and bid defense proposals
• Prepare presentations and represent the company at professional meetings and with prospective and existing clients as required
• Works closely with Marketing to promote laboratory and medical affairs expertise.
• Engage proactively at the executive and medical level with clients
• Experience that satisfies the personnel requirement of CLIA 1988 or other local applicable regulations for laboratory director

Education/Certification & Experience

• MD degree
• Board Certification in Anatomic Pathology and Clinical Pathology
• Excellent interpersonal skills and the ability to communicate comfortably with individuals at all levels from a multitude of educational, scientific, professional and national or international backgrounds
• Possesses or can acquire local, state or country laboratory regulatory/medical licenses required for business operation
• Minimum of 10 years of relevant industry or related experience
• Must have pathologist and people management experience and demonstrated financial awareness
• Proven client facing skills
• Global leadership experience preferred
• Pharmaceutical, central laboratory, device manufacturing, clinical trial background preferred

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