Clinical Director (Principal Scientist), Clinical Research, Immunology - Rheumatology
Merck
4 months ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Clinical Director (Principal Scientist) responsible for planning and directing clinical research activities for new or marketed medicines in the Immunology therapeutic area; may manage end-to-end clinical development for assigned studies (study design, initiation, execution, monitoring, analysis, regulatory reporting, publication).
Role Responsibilities
- Plan clinical trials (including designing and collaborating on operational plans) based on clinical development strategy.
- Provide medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs.
- Analyze and summarize clinical findings to support decisions on safety and efficacy, new drug applications, clinical study reports, and publication.
- 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.
May
- Engage with other functional areas to support study execution.
- Work with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Help ensure colleagues are informed of progress of company and competitor drug studies.
- Provide expert opinion (internally and externally) on relevant scientific questions within scope.
Scientific leadership/maintenance of knowledge
- Stay current on scientific developments and research methodologies in their expertise area.
- Identify strong investigators to support development of company investigational/marketed drugs.
- Establish communications with prominent clinical investigators in relevant fields.
- Attend appropriate scientific meetings to maintain competency and awareness.
May also
- Author development documents, presentations, budgets, and position papers for internal and external audiences.
- Facilitate global collaborations with external researchers.
- Travel about 20% of the time to manage future or ongoing clinical research projects.
Education
- M.D. or M.D./Ph.D.
Required Experience and Skills
- Industry experience or senior faculty experience in academia.
- Minimum 3 years of clinical medicine experience.
- Minimum 1 year of industry drug development experience 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 and ability to function in a team environment.
- Provide expert opinion (internally and externally) on relevant scientific questions within scope.
Preferred Experience and Skills
- Board Certified or Eligible in Rheumatology (or related discipline).
- Prior specific experience in clinical research and prior publication.
Required Skills
- Allergy and Immunology; Clinical Development; Clinical Documentation; Clinical Immunology; Clinical Medicine; Clinical Reporting; Clinical Research; Clinical Trial Planning; Clinical Trials; Clinical Trial Support; Drug Development; Ethical Standards; Leadership; Regulatory Requirements; Rheumatology.
Application
- Apply through https://jobs.merck.com/us/en.
Role Responsibilities
- Plan clinical trials (including designing and collaborating on operational plans) based on clinical development strategy.
- Provide medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs.
- Analyze and summarize clinical findings to support decisions on safety and efficacy, new drug applications, clinical study reports, and publication.
- 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.
May
- Engage with other functional areas to support study execution.
- Work with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Help ensure colleagues are informed of progress of company and competitor drug studies.
- Provide expert opinion (internally and externally) on relevant scientific questions within scope.
Scientific leadership/maintenance of knowledge
- Stay current on scientific developments and research methodologies in their expertise area.
- Identify strong investigators to support development of company investigational/marketed drugs.
- Establish communications with prominent clinical investigators in relevant fields.
- Attend appropriate scientific meetings to maintain competency and awareness.
May also
- Author development documents, presentations, budgets, and position papers for internal and external audiences.
- Facilitate global collaborations with external researchers.
- Travel about 20% of the time to manage future or ongoing clinical research projects.
Education
- M.D. or M.D./Ph.D.
Required Experience and Skills
- Industry experience or senior faculty experience in academia.
- Minimum 3 years of clinical medicine experience.
- Minimum 1 year of industry drug development experience 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 and ability to function in a team environment.
- Provide expert opinion (internally and externally) on relevant scientific questions within scope.
Preferred Experience and Skills
- Board Certified or Eligible in Rheumatology (or related discipline).
- Prior specific experience in clinical research and prior publication.
Required Skills
- Allergy and Immunology; Clinical Development; Clinical Documentation; Clinical Immunology; Clinical Medicine; Clinical Reporting; Clinical Research; Clinical Trial Planning; Clinical Trials; Clinical Trial Support; Drug Development; Ethical Standards; Leadership; Regulatory Requirements; Rheumatology.
Application
- Apply through https://jobs.merck.com/us/en.