Senior Director, Clinical Development Metabolism (MASH)

Job Description

The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Metabolism section of the Atherosclerosis & Metabolism therapeutic area, with a particular focus on MASH (Metabolic Dysfunction-Associated Steatohepatitis) and other obesity-related disorders. Our company's Atherosclerosis & Metabolism medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of late-stage clinical development and studies, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.

Specifically, the Senior Director May Be Responsible For:

• Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed drugs
• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication
• Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds.
• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications;
• Developing clinical development strategies for investigational or marketed drugs
• Support of business development assessments of external opportunities

The Senior Director May:

• Work closely with the Clinical Scientists in the execution of clinical studies. Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director and/or Associate Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs, and of internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.

The Senior Director is responsible for maintaining a strong scientific fund of knowledge by:

• Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings and research methodologies
• Identifying scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs
• Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs
• Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility.

To accomplish these goals, the Senior Director may:

• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitate collaborations with external researchers around the world.
• Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.

Qualifications

Education

M.D or M.D./Ph.D.

Required

• Must have 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 experience in academia
• Demonstrated success in overseeing clinical studies and protocols
• Demonstrated record of scientific scholarship and achievement
• Proven track record in clinical medicine and background in biomedical research
• Strong interpersonal skills, as well as the ability to function in a team environment
• Outstanding verbal and written communication and presentation skills

Preferred

• Board Certified or Eligible in Endocrinology, Gastroenterology, Hepatology or related discipline

• Direct clinical research experience in MASH, with a preference for candidates who have designed, executed, or medically monitored Phase 2 or Phase 3 trials in metabolic liver diseases

Required Skills:

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

Preferred Skills:

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US and Puerto Rico Residents Only:

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