Director, Clinical Research, Obesity

MSD•Boston, MA

3d•$255,800 - $402,700

About The Position

The Director (Principal Scientist) is responsible for planning and directing clinical research involving new or marketed medicines in the Metabolism section of the Atherosclerosis & Metabolism therapeutic area, with a focus on obesity and obesity-related disorders. The company’s medicines span all phases of clinical development, from pre-clinical research through post-licensure. The Director manages the full cycle of late-stage clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. The role works collaboratively with Clinical Scientists and cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects. It also supports business development assessments, helps keep relevant corporate personnel informed about study progress and scientific opinion, and maintains expertise in the field through scientific engagement and investigator relationships. The Director may author development documents and presentations, facilitate collaborations with external researchers worldwide, and travel on company business approximately 25% of the time.

Requirements

M.D. or M.D./Ph.D.
Experience in industry or as faculty in academia.
At least 3 years of experience in clinical medicine.
At least 1 year of industry experience in drug development or biomedical research experience in academia.
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.
Strong verbal and written communication and presentation skills.
Clinical development, clinical research, clinical trial planning, cross-functional teamwork, liver diseases, and obesity skills.

Nice To Haves

Board certified or eligible in Endocrinology, Gastroenterology, Hepatology, Cardiology, Nephrology, or a related discipline.
Prior specific experience in clinical research and prior publication.

Responsibilities

Plan clinical trials, including their design, operational plans, and settings, in alignment with clinical development strategies.
Monitor and manage ongoing and 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 related to development of new compounds and further study of marketed compounds.
Support business development assessments of external opportunities.
Collaborate with Clinical Scientists in executing clinical studies.
Work with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
Help ensure appropriate corporate personnel are informed about the progress of company and competitor drug studies and relevant internal and external scientific opinion.
Maintain awareness of scientific developments, research findings, and methodologies in the area of expertise.
Identify scientifically and operationally strong investigators and establish communications with prominent clinical investigators who can assist in evaluating company drugs.
Attend scientific meetings to maintain competency and awareness of research in areas of responsibility.
Author development documents, presentations, and position papers for internal and external audiences as needed.
Facilitate collaborations with external researchers around the world.
Travel on company business to manage future or ongoing clinical research projects.