Director, Clinical Research, Obesity

Job Description

The Director (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 focus on obesity and obesity‑related disorders.

Our company's Atherosclerosis & Metabolism medicines span all phases of clinical development (pre‑clinical to post‑licensure).

The Director will manage the entire cycle of clinical development for late‑stage studies, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. Specifically, the Director will 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.
• Support of business development assessments of external opportunities.
• Collaborating with the Clinical Scientists in the execution of clinical studies.
• Working closely with a cross‑functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects, and assisting the team 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.
• 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.
• Authoring detailed development documents, presentations, and position papers for internal and external audiences.
• Facilitating collaborations with external researchers around the world.
• Traveling on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.

Required

• Education:
  
  M.D. or M.D./Ph.D. Experience required in industry or faculty in academia.
• Minimum of 3 years of experience in clinical medicine.
• Minimum of 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 background in biomedical research.
• Strong interpersonal skills, as well as the ability to function in a team environment.
• Strong verbal and written communication and presentation skills.

Preferred

• Board Certified or Eligible in Endocrinology, Gastroenterology, Hepatology, Cardiology, Nephrology, or related discipline.
• Prior specific experience in clinical research and prior publication.

• Clinical Development
• Clinical Research
• Clinical Trial Planning
• Cross‑Functional Teamwork
• Liver Diseases
• Obesity

• None specified

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans…