Director, Clinical Research, Obesity

Merck•Boston, MA

49d•$255,800 - $402,700

About The Position

The Director (Principal Scientist) is primarily 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 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 Director collaborates with Clinical Scientists and works with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects. The role also supports business development assessments of external opportunities and helps ensure relevant Corporate personnel are informed about study progress, competitor medicines, and internal and external scientific opinions. The Director maintains scientific expertise by following developments and research methodologies, identifying and communicating with clinical investigators, and attending relevant scientific meetings. The position may involve authoring development documents, presentations, and position papers; facilitating collaborations with external researchers around the world; and business travel. The posting specifies travel requirements of 25%.

Requirements

M.D. or M.D./Ph.D.
Experience in industry or faculty experience 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.

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 study design, operational plans, and settings, based on 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 developing new compounds and further studying 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 study progress, competitor medicines, and relevant internal and external scientific opinions.
Maintain awareness of scientific developments and research methodologies in the area of expertise.
Identify scientifically and operationally strong investigators who can support development of investigational and marketed drugs.
Establish communications with prominent clinical investigators who may assist in evaluating company drugs.
Attend appropriate scientific meetings to maintain competency and awareness of research activity.
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.