Role Summary
Team Incretins Outcomes is looking for a certified hepatologist, with proven experience in metabolic dysfunction-associated steatohepatitis (MASH) trials, to support a future MASH outcome trial. This role will work with a broader team of physicians on the day-to-day medical operations of the trial and will report to the Sr. Director Medical - Incretin Outcomes.
Responsibilities
- The development, conduct and reporting of corporate/global clinical trial(s) in support of registration and commercialization of potential MASH products
- The implementation of global clinical trials in these fields
- The reporting of adverse events as mandated by corporate patient safety
- The review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts
- Contacts with regulatory and other governmental agencies
- Outreach medical activities aimed at the external clinical customer community, including thought leaders
- The development and implementation of the business unit and global strategy for the product
- Various medical activities in support of demand realization
- Serves as a scientific resource for study teams, departments, and others as needed
Qualifications
- Required: Medical Doctor. Must be board eligible or certified in a medical specialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.
- Required: Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the LCME
- Preferred: Experience in Phase 3 clinical trials
- Preferred: Board certification in gastroenterology or (pediatric) hepatology
- Preferred: Additional advanced degree (e.g. PhD, MBA)
- Preferred: Demonstrated knowledge of obesity and/or MASH drug development process and molecule life cycle
- Preferred: Fluent in English; both written and verbal communications
- Preferred: Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills
- Preferred: Demonstrated ability to influence others (cross-functionally and within the function) to create a positive working environment
- Preferred: Ability to engage in domestic and international travel to the degree appropriate to support the business of the team
Additional Requirements