Responsibilities:
- Plan and direct clinical research activities for new or marketed medicines in Metabolism, focused on MASH and other obesity-related disorders.
- Manage the full late-stage clinical development cycle: development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
- Plan clinical trials (design, operational plans, settings) based on clinical development strategies.
- Monitor and manage ongoing or new clinical trials for investigational or marketed drugs.
- Analyze and summarize clinical findings to support safety/efficacy decisions and submissions/publication (e.g., NDA, clinical study reports).
- Participate in internal and joint internal/external research project teams for new compounds and further study of marketed compounds.
- Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug (IND) applications.
- Develop clinical development strategies for investigational or marketed drugs.
- Support business development assessments of external opportunities.
- Work cross-functionally with experts in commercialization, regulatory affairs, statistics, and manufacturing; collaborate with Clinical Scientists.
- Maintain a strong scientific knowledge base and network with investigators; attend scientific meetings.
- Author development documents, presentations, budgets, and position papers; facilitate global collaborations; travel ~20% to manage clinical projects.
Qualifications:
- Education: M.D. or M.D./Ph.D.
- Required: Industry or senior faculty academia experience; 3+ years clinical medicine; 3β5 years industry drug development or biomedical research (academia); proven success overseeing clinical studies/protocols; record of scientific scholarship; track record in clinical medicine and biomedical research; strong interpersonal and verbal/written communication.
- Preferred: Board Certified/Eligible in Endocrinology, Gastroenterology, or Hepatology (or related); direct MASH research experience with Phase 2/3 metabolic liver disease trial design/execution/medical monitoring.