Senior Director, Clinical Development Metabolism; MASH

Responsibilities

• Plan and direct clinical research activities for new or marketed medicines in Metabolism, with focus on MASH and other obesity-related disorders.
• Manage the full late-stage clinical development cycle: strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
• Plan clinical trials (design, operational plans, settings) and monitor/managing ongoing or new trials.
• Analyze/summarize clinical findings to support safety/efficacy decisions, NDA/clinical study reports, and publications.
• Evaluate preclinical/translational work to develop early clinical plans and Investigational New Drug (IND) applications.
• Participate in internal and internal/external research project teams for new and marketed compounds.
• Support business development assessments of external opportunities.
• Maintain a scientific knowledge base; identify investigators and collaborate with prominent clinical investigators; attend scientific meetings.
• Author development documents, presentations, budgets, and position papers; facilitate global collaborations.

• M.D. or M.D./Ph.D.
• Required:
  
  industry or senior faculty academia experience; 3+ years clinical medicine; 3–5 years industry drug development or biomedical research in academia; demonstrated success overseeing clinical studies/protocols; scientific scholarship; strong interpersonal and verbal/written communication.
• Preferred: board certified/eligible in Endocrinology, Gastroenterology, or Hepatology (or related); direct MASH clinical research with Phase 2/3 metabolic liver disease trial experience.
• Required skills:
  
  Cardiology, Clinical Development, Clinical Trials, Drug Development, Endocrinology, Hepatology, Liver Diseases, Nephrology, Obesity, Pharmaceutical Industry.