Vice President, Clinical and Medical Affairs

Naveris

3d

About The Position

Naveris is a privately held, commercial stage, precision oncology diagnostics company dedicated to improving outcomes for the millions of people at risk of developing viral-induced cancers by developing novel molecular diagnostics that enable earlier cancer detection. Our flagship product, the NavDx® test, is used in routine clinical practice by thousands of physicians across the U.S. to monitor for molecular residual disease (MRD) of head & neck and anal cancers caused by the human papilloma virus. The NavDx test has been designated an Advanced Diagnostic Laboratory Test (ADLT) by CMS. Naveris operates high-complexity testing clinical laboratories that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center, and are certified under CLIA.

Naveris is seeking a highly motivated and innovative candidate to serve as Vice President, Clinical and Medical Affairs, leading our clinical operations, evidence generation, and provider engagement and education efforts. This role will report to the Chief Scientific and Innovation Officer (CSIO) and will be a part of the Naveris Leadership Team.

The VP, Clinical and Medical Affairs will have primary responsibility for three strategic areas of our business:
Overseeing our clinical operations team that is responsible for the planning and execution of all clinical studies and collaborations with both academic research partners as well as biopharmaceutical companies,
Leading our evidence generation team that is responsible for the development, publication, and promotion of scientific and clinical evidence that supports utilization of NavDx and that drives expansion of clinical use cases for our proprietary biomarker technologies
Partnering with other stakeholders in the Company, including the Medical Laboratory Director, Market Access, Billing and Reimbursement and Commercial, to engage with physicians, surgeons, other healthcare providers, and payors to provide evidence-based education on the clinical benefits of NavDx testing in a range of use cases

Requirements

• M.D., D.O., or M.D./Ph.D licensed to practice medicine in the United States (required) and eligible to hold valid Massachusetts and North Carolina medical licenses (strongly preferred)
• Board Certification in Pathology, Medical Oncology, Radiation Oncology, Otolaryngology, Gynecologic Oncology, or Colorectal Surgery strongly preferred. Other board certifications considered based on experience
• At least 10 years experience in direct patient care (including training and fellowship) focused in oncology, with participation in multidisciplinary cancer care teams highly beneficial
• Demonstrated track record of scientific and clinical publications in top-tier journals, either as an author or through corporate sponsorship of the related studies
• Demonstrated experience managing retrospective studies such as medical records and real-world data studies
• Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines
• Industry experience preferred, with experience in molecular diagnostics, liquid biopsy or other oncology related companies highly beneficial
• Experience working with Medicare, commercial insurance, and other stakeholders in the market access and payor community would make a candidate truly stand out for this role
• Experience working with high-complexity CLIA laboratories for genomic testing technologies will also differentiate outstanding candidates
• In-depth knowledge of oncology, molecular diagnostics and genomics
• Strong leadership and communication skills, with the ability to collaboratively problem-solve and build trusting relationships
• Demonstrated ability to lead a diverse team of scientific and clinical professionals, building and maintaining a strong culture with high employee morale and engagement
• The ability to work effectively in a corporate setting, collaborating cross-functionally with non-laboratory and non-scientific personnel to advance Company objectives and enhance patient care

Nice To Haves

• eligible to hold valid Massachusetts and North Carolina medical licenses
• Other board certifications considered based on experience
• participation in multidisciplinary cancer care teams highly beneficial
• Industry experience preferred, with experience in molecular diagnostics, liquid biopsy or other oncology related companies highly beneficial
• Experience working with Medicare, commercial insurance, and other stakeholders in the market access and payor community would make a candidate truly stand out for this role
• Experience working with high-complexity CLIA laboratories for genomic testing technologies will also differentiate outstanding candidates

Responsibilities

• Create multi-year evidence generation roadmaps that align to the Company’s product, regulatory, market access and commercial strategies. Lead the execution of the studies required to deliver on the roadmap, including prospective, retrospective, registry, and real-world evidence studies. Ensure that all processes comply with regulatory standards
• Direct the development of clinical strategies and plans to integrate Naveris’ technologies into standard-of-care practice and associated guidelines across targeted indications in oncology diagnostics
• Lead a cross-functional team to deliver clinical project plans that include key milestones and activities, and communicate program details, risks, and mitigation to the Leadership Team and external partners and stakeholders
• Serve as a resource across the Company for providing peer-to-peer education about Naveris technologies and projects. Participate in physician consultations related to NavDx testing, prepare and present educational content to internal and external stakeholders, and represent the Company at industry events focused on clinical education (e.g. CME programs, conference symposia)
• Be responsible for the strategy, design, and execution of KOL engagement, including engaging with thought leaders responsible for setting clinical practice guidelines in our relevant fields
• Represent Naveris at scientific and medical conferences and with regulatory agencies, payors, and advisory boards, when required. Build and maintain a strong presence at external scientific, clinical, and society events to establish Naveris as a science and data-driven leader in the field of early cancer detection
• Interface closely with the CLIA Lab leadership to ensure consistent performance and quality for testing services related to clinical studies and partnerships. Ensure coordination with Medical Laboratory Director for all physician outreach and consultations
• Provide executive leadership to the Clinical and Medical Affairs organization with responsibility for all personnel, budget, and administrative matters for the department. Represent the department on the Naveris Leadership Team to ensure seamless cross-functional collaboration across the Company

Benefits

• Health Insurance Portability and Accountability Act (HIPAA) is a federal law that describes the national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge. All roles at Naveris require compliance with legal and regulatory requirements of HIPAA and acceptance and adherence to all policies and standards at Naveris. Personnel acknowledges they are personally responsible for reporting any suspected violations or abuse and are required to complete HIPAA training when joining the company.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree