Senior Director, Clinical Development Metabolism (MASH)
About The Position
The Senior Director (Sr. Principal Scientist) leads clinical research activities involving new or marketed medicines in the Metabolism section of the Atherosclerosis & Metabolism therapeutic area, with particular focus on MASH and other obesity-related disorders. The role manages late-stage clinical development across the full study lifecycle, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. The Senior Director may work closely with Clinical Scientists and cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects. The role also helps keep corporate personnel informed about study progress, competitor medicines, and relevant scientific opinion. It maintains a strong scientific knowledge base, identifies and communicates with investigators, and attends scientific meetings. The role may involve preparing development documents, presentations, budgets, and position papers; facilitating collaborations with external researchers worldwide; and traveling on company business. The posting lists travel requirements of 25%. The primary location is Rahway, New Jersey. Domestic relocation and visa sponsorship are available.
Requirements
- M.D. or M.D./Ph.D.
- Experience in industry or as senior faculty in academia.
- At least 3 years of experience in clinical medicine.
- At least 3–5 years of industry experience in drug development or biomedical research experience in academia.
- Demonstrated success overseeing clinical studies and protocols.
- Demonstrated record of scientific scholarship and achievement.
- Track record in clinical medicine and background in biomedical research.
- Strong interpersonal skills and ability to function in a team environment.
- Outstanding verbal and written communication and presentation skills.
- Required skills listed: Cardiology, Clinical Development, Clinical Trials, Drug Development, Endocrinology, Hepatology, Liver Diseases, Nephrology, Obesity, and Pharmaceutical Industry.
Nice To Haves
- Board certified or board eligible in Endocrinology, Gastroenterology, Hepatology, or a related discipline.
- Direct clinical research experience in MASH; preference for candidates who have designed, executed, or medically monitored Phase 2 or Phase 3 trials in metabolic liver diseases.
Responsibilities
- Develop clinical development strategies for investigational or marketed drugs.
- Plan clinical trials, including design, operational plans, and settings, based on clinical development strategies.
- Monitor and manage ongoing or new clinical trials for investigational or marketed drugs.
- Analyze and summarize clinical study findings to support safety and efficacy decisions, new drug applications, clinical study reports, and publications.
- Participate in internal and joint internal/external research project teams involving 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.
- Support business development assessments of external opportunities.
- Work with Clinical Scientists in executing clinical studies and collaborate with experts in commercialization, regulatory affairs, statistics, and manufacturing to manage development projects.
- Assist the Executive Director and/or Associate Vice President in informing corporate personnel about study progress, competitor drugs, and relevant internal and external scientific opinion.
- Maintain awareness of scientific developments, research findings, and methodologies in the area of expertise.
- Identify strong scientific and operational investigators and establish communications with prominent clinical investigators.
- Attend scientific meetings to maintain competency and awareness of research activities.
- Author development documents, presentations, budgets, and position papers for internal and external audiences.
- Facilitate collaborations with external researchers around the world.
- Travel on company business to manage future or ongoing clinical research projects.
Benefits
- Medical, dental, and vision healthcare benefits and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Eligible for annual bonus and long-term incentive, if applicable.
- Domestic relocation assistance is listed.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
