Senior Director, Clinical Development Metabolism (MASH)
About The Position
The Senior Director (Sr. Principal Scientist) plans and directs clinical research involving new or marketed medicines in the Metabolism section of the Atherosclerosis & Metabolism therapeutic area, with particular focus on MASH (Metabolic Dysfunction-Associated Steatohepatitis) and other obesity-related disorders. The role manages the full cycle of late-stage clinical development and studies, 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 may also help ensure corporate personnel are informed about study progress, competitor drugs, and relevant internal and external scientific opinions. The position maintains scientific expertise by tracking developments and research methods, identifying and communicating with clinical investigators, and attending relevant scientific meetings. It may involve authoring development documents, presentations, budgets, and position papers; facilitating collaborations with external researchers around the world; and traveling on company business to manage clinical research projects. The posting lists travel requirements as 25%.
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.
- Proven track record in clinical medicine and a 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 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
- 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 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 supporting 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.
- Work with Clinical Scientists and cross-functional experts to manage clinical development projects.
- Help keep appropriate corporate personnel informed about study progress, competitor drugs, and relevant scientific opinions.
- Maintain awareness of scientific developments and research methodologies in the area of expertise.
- Identify scientifically and operationally strong investigators and establish communications with prominent clinical investigators.
- Attend appropriate 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, vision healthcare, and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
