Senior Director, Clinical Development Metabolism (MASH)

About the role

The Senior Director (Sr. Principal Scientist) is responsible for planning and directing clinical research activities involving new or marketed medicines in the Metabolism section of the Atherosclerosis & Metabolism therapeutic area, with a focus on MASH (Metabolic Dysfunction-Associated Steatohepatitis) and other obesity-related disorders. This role oversees the entire cycle of late-stage clinical development, including strategy, study design, execution, monitoring, analysis, regulatory reporting, and publication for medicines spanning all phases of clinical development (pre-clinical to post-licensure).

Responsibilities

• Plan clinical trials, including design, operational plans, and settings, based on clinical development strategies.
• Monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed drugs.
• Analyze and summarize clinical findings to support decisions on safety, efficacy, new drug applications, clinical study reports, or publications.
• Participate in internal and joint internal/external research project teams for the development of new compounds and further study of marketed compounds.
• Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug applications.
• Develop clinical development strategies for investigational or marketed drugs.
• Support business development assessments of external opportunities.
• Collaborate with Clinical Scientists in executing clinical studies and work closely with cross-functional teams, including commercialization, regulatory affairs, statistics, and manufacturing.
• Assist the Executive Director and/or Associate Vice President in keeping Corporate personnel informed about study progress, competitor drugs, and expert opinions on scientific questions.
• Maintain a strong scientific knowledge base by staying updated on new findings, methodologies, and research activities in the field.
• Identify and establish communications with prominent clinical investigators to assist in drug development.
• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitate collaborations with external researchers globally.
• Travel approximately 20% of the time to manage clinical research projects.

Requirements

• M.D. or M.D./Ph.D. required.
• Experience in industry or as senior faculty in academia.
• Minimum of 3 years of experience in clinical medicine.
• Minimum of 3-5 years of industry experience in drug development or biomedical research in academia.
• Demonstrated success in overseeing clinical studies and protocols.
• Proven track record in clinical medicine and biomedical research.
• Strong interpersonal skills and ability to function in a team environment.
• Outstanding verbal and written communication and presentation skills.

Qualifications

• Board Certified or Eligible in Endocrinology, Gastroenterology, Hepatology, or a related discipline (preferred).
• Direct clinical research experience in MASH, with preference for candidates who have designed, executed, or medically monitored Phase 2 or Phase 3 trials in metabolic liver diseases (preferred).

Skills

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

Pay

The salary range for this role is $282,200.00 - $444,200.00. An employee’s position within the salary range will be based on factors including relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Comprehensive medical, dental, and vision healthcare for employee and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate, and sick days.

Schedule

• Travel requirements: 25%