Principal Scientist, Clinical Research
About The Position
The Principal Scientist (identified in the posting as Director) plans and directs clinical research involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The medicines span clinical development from pre-clinical research through post-licensure. The role manages the full cycle of late-stage clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. The position works with Clinical Scientists and cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to advance clinical development projects. It also supports business development assessments, contributes to internal and external research teams, and helps ensure relevant corporate personnel are informed about study progress, competitor drugs, and expert opinion on scientific questions. The role maintains scientific expertise by tracking developments and research methods, identifying and communicating with investigators, and attending scientific meetings. It may involve authoring development documents, presentations, budgets, and position papers; facilitating collaborations with external researchers worldwide; and business travel of approximately 20% to manage clinical research projects.
Requirements
- M.D. or M.D./Ph.D.
- Experience in industry or as senior faculty in academia.
- At least 3 years of clinical medicine experience.
- 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.
Nice To Haves
- Board certified or board eligible in Cardiology (adult or pediatric), Endocrinology, Nephrology, or a related discipline.
- Prior specific experience in clinical research.
- Prior publication.
Responsibilities
- Plan clinical trials, including study design, operational plans, and settings, in accordance with clinical development strategies.
- Monitor and manage ongoing or new clinical trials for investigational or marketed Atherosclerosis & Metabolism 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 for development of new compounds and further study of marketed compounds.
- Support business development assessments of external opportunities.
- Collaborate with Clinical Scientists on the execution of 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 drugs, and relevant internal and external scientific opinions.
- Maintain awareness of scientific developments and research methodologies in the area of expertise.
- Identify strong clinical investigators and establish communications with prominent investigators who may assist in evaluating company drugs.
- Attend appropriate scientific meetings to maintain competency and awareness of research activities.
- Author development documents, presentations, budgets, and position papers for internal and external audiences.
- Facilitate collaborations with external researchers around the world.
- Travel on company business approximately 20% of the time to manage clinical research projects.
Benefits
- Medical, dental, vision healthcare, and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays.
- Vacation.
- Compassionate and sick days.
- Annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
