Senior Director, Clinical Research, Atherosclerosis

Responsibilities

• Plan and direct clinical research activities for new or marketed Atherosclerosis medicines across all phases of development.
• Manage late-stage clinical development end-to-end: 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 Atherosclerosis drugs.
• Analyze and summarize clinical findings to support safety/efficacy decisions, new drug applications, clinical study reports, and publications.
• Participate in internal and joint internal/external research project teams for development of new and marketed compounds.
• Evaluate pre-clinical and translational work to generate early clinical development plans and INDs.
• Develop clinical development strategies for investigational or marketed Atherosclerosis drugs.
• Support business development assessments of external opportunities.

Qualifications

• Education: 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; proven success overseeing Phase 2/3 studies and protocols; strong scientific scholarship; track record in clinical medicine and biomedical research; interpersonal teamwork; outstanding verbal/written communication.
• Preferred: Board Certified/Eligible in Cardiology (adult/pediatric), Endocrinology, or Nephrology or related; prior clinical research experience and publication.

Required skills

• Atherosclerosis, Cardiovascular Diseases, Clinical Development/Research, Clinical Trials, Cross-Functional Teamwork, Drug Development, Medical Monitoring, Scientific Writing.