Vice President Medical Affairs
This executive will lead the Global Medical Affairs team and will ensure the world-wide medical strategy in the area of post-market clinical studies of all types (validation, intervention, HEOR, etc. are successful.
Location: Raleigh-Durham, NC OR Boston, MA
· Establishes and maintains the level of medical and scientific expertise of team members in their respective areas to provide relevant advice to stakeholders in the company.
· Defines the strategy, methodology, standardization, harmonization and priorities related to all aspects of post-market (i.e. non-registration) clinical studies with an emphasis on interventional and Health Economic and Outcomes Research (HEOR)
· Ensure the appropriate, timely and effective communication of clinical trial results to all internal and external stakeholders
· Coordinates actions to increase the scientific and medical visibility of the company: through scientific publications, symposium or workshops, participation in professional or medical societies or healthcare authorities.
· Is accountable for the validation of documents produced by the team members: patient risk analysis, position papers, publications, etc…
· Leads the development and coordination of the MSL (medical and scientific liaison) team (not currently in existence, but planned)
· Sets up organization of the team, identifies appropriate skills to achieve objectives, develop team members, ensures appropriate budget and resources management
Education and Experience:
· Medical Doctor or PHD with relevant experience in the clinical field (such as medical practice, laboratory medicine, applied medicine, clinical trials) with pertinent and relevant experience or interactions with pharma/IVD industry.
· Minimum required: more than 10 years of experience in management of more than 15 people
Skills and Qualifications:
· Excellent knowledge of hospital /clinical / medical issues, clinical trials, reimbursement environment, industrial medical affairs activities
· Excellent knowledge of in vitro diagnostics (microbiology preferred) and Infectious Diseases/Acute Care Medicine
· Excellent personnel and project management skills and relevant experience;
Scope and Resources Accountability, typical Performance Indicators:
Scope and Resources Accountability: Management of up to 10 people;
Financial Indicators (revenue, budget, etc.): Consulting budget, financialbudget for medical trials; overall budget attainment.
Key Performance Indicators (KPIs): Number of publications, size of expert and KOL networks, number of internal consultations and project interactions.
Key Contacts (internal / external) and Interfaces:
Internal : R&D, marketing, clinical affairs, CCMC, GCS, RA, communication, subsidiaries.
External : Experts, KOL’s and clinicians, medical consultants, medical societies, local / regional / national / international healthcare bodies in the Americas.