Principal Scientist, Clinical Research

Job Description

The Director (Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. 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 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 Atherosclerosis & Metabolism 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; and
• 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

The Director may:

Collaborate 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 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.

The 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, 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 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 senior faculty in academia
• Minimum of 3 years of clinical medicine experience
• 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 Cardiology (adult or pediatric), Endocrinology, or Nephrology or related discipline
• Prior specific experience in clinical research and prior publication

Required Skills:

Academic Presentations, Academic Presentations, Academic Research, Adaptability, Allergy and Immunology, Biomedical Research, Biotechnology, Clinical Development, Clinical Investigations, Clinical Judgment, Clinical Protocols, Clinical Reporting, Clinical Research, Clinical Sciences, Clinical Trial Development, Clinical Trial Planning, Clinical Trial Support, Contract Research Organizations (CROs), Cross-Functional Teamwork, Drug Research, Ethical Standards, Intellectual Curiosity, New Technology Integration, Pharmaceutical Industry, Pharmaceutical Research {+ 8 more}

Preferred Skills:

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US and Puerto Rico Residents Only:

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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. …