Senior Director, Clinical Development Metabolism (MASH)

Responsibilities

• Plan and direct late-stage clinical research for new or marketed medicines in Metabolism, with focus on MASH and obesity-related disorders.


• Manage the full clinical development cycle: strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.


• Plan clinical trials (design, operational plans, settings); monitor and manage ongoing/new clinical trials.


• Analyze and summarize clinical findings to support safety/efficacy decisions and submissions/publication (e.g., INDs, clinical study reports).


• Participate in internal and joint internal/external research teams for new and marketed compounds.


• Evaluate pre-clinical/translational work to generate early clinical plans and IND applications; develop clinical development strategies; support business development assessments.


• Maintain scientific knowledge via awareness of advances, investigator identification, key investigator communications, and attendance at scientific meetings.


• Author development documents/budgets/presentations/position papers; facilitate worldwide external collaborations; travel ~20% to manage clinical projects.

Qualifications

• Education: M.D. or M.D./Ph.D.


• Required: Experience in industry or senior faculty in academia; 3+ years clinical medicine; 3-5 years industry drug development or biomedical research in academia; demonstrated success overseeing clinical studies/protocols; strong scientific scholarship; proven clinical medicine with biomedical research background; strong interpersonal/team skills; outstanding verbal/written communication.


• Preferred: Board certified/eligible in Endocrinology, Gastroenterology, or Hepatology (or related); direct MASH clinical research; designed/executed/medically monitored Phase 2/3 trials in metabolic liver diseases.

Skills (required)

• Cardiology, Clinical Development, Clinical Trials, Drug Development, Endocrinology, Hepatology, Liver Diseases, Nephrology, Obesity, Pharmaceutical Industry.

Compensation/benefits (as stated)

• Salary $282,200-$444,200


• eligible for annual bonus and long-term incentive (if applicable)


• comprehensive benefits including medical/dental/vision, 401(k), paid holidays, vacation, and sick/compassionate days