VP Clinical Affairs

PURPOSE OF JOB:

The Vice President, Clinical Affairs has primary responsibility for the development and execution of the clinical strategy for Route 92 Medical.

RESPONSIBILITIES:

• Plan and execute clinical trials while ensuring compliance with applicable regulations, standards and procedures.
• Partner with scientific advisors, key opinion leaders, therapeutic area experts, and selected national principal investigators to design and develop study protocols that support the company’s business objectives.
• Play an important liaison role cross-functionally with Regulatory Affairs, Research and Development, Quality Assurance, Operations, Marketing, Training and Sales to communicate clinical trial objectives and ensure alignment for milestone development.
• Select vendors and negotiate contracts for external clinical research services such as CROs, Imaging Core Lab, Data Management, Statistical Analysis, Data Monitoring Committee and Clinical Consultants.
• Provide leadership, guidance and direction to clinical trial team.
• Ensure the successful completion of clinical trials including investigator recruitment and selection, investigator meetings, IRB/EC approvals, site contract and budget negotiations, site training, patient enrollment, data monitoring, safety reporting, document retention, data lock and study close-out.
• Provide oversight for the development of case report forms and informed consent forms for each assigned study.
• Partner with medical advisors, data management and biostatistician(s) to develop and provide clinical study reports for regulatory submission as well as abstracts and manuscripts for submission to scientific conferences and peer review journals.
• Partner with finance to develop and provide study budgets.
• Partner with CROs to identify, recruit, select and retain talented clinical research professionals.
• Work in accordance with the Route 92 Quality System Procedures.

PREFERRED EDUCATION:

Earned degree in a medical or scientific discipline or equivalent experience.

PREFERRED EXPERIENCE:

At least 15 years of experience managing both U.S. and OUS clinical studies in the medical device industry. Strong organizational, project management, written/verbal communication and interpersonal skills. Proven experience in relationship building and communication with the medical community.

ADDITIONAL SKILLS:

Working knowledge of the following standards and regulations:

• Internal Organization for Standardization (ISO) 14155, Clinical investigation of medical devices for human subjects-Good clinical practice
• The International Conference on Harmonization (ICHhH) for Good Clinical Practice (GCP), ICH E6
• 21 CFR Part 812 Investigational Device Exemptions
• 21 CFR Part 50 Protection of Human Subjects
• 21 CFR Part 54 Financial Disclosure by Clinical Investigators
• 21 CFR Part 56 Institutional Review Boards
• Declaration of Helsinki
• European Union (EU) Medical Device Directive (MDD)