Clinical Director (Principal Scientist), Clinical Research, Immunology - Rheumatology
Merck
4 months ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Immunology therapeutic area, managing the full clinical development cycle (study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication).
Role Responsibilities
- Plan clinical trials based on the 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 safety/efficacy decisions and submissions/publications (e.g., new drug applications, clinical study reports, publications).
- Participate in internal and internal/external research project teams relevant to development of new compounds and further study of marketed compounds.
- Support business development assessments of external opportunities.
The Clinical Director May
- Engage with other functional areas to support study execution.
- Work with cross-functional experts (commercialization, regulatory affairs, statistics, manufacturing) to manage clinical development projects.
- Help ensure colleagues are informed of progress of company and competitor studies.
- Provide expert opinion internally and externally on scientific questions within their responsibility.
Scientific knowledge responsibilities
- Maintain awareness of scientific developments and research methodologies in their expertise.
- Identify strong investigators to support drug development.
- Establish communications with prominent clinical investigators.
- Attend appropriate scientific meetings.
To accomplish these goals, the Clinical Director may
- Author detailed development documents, presentations, budgets, and position papers.
- Facilitate collaborations with external researchers worldwide.
- Travel ~20% to manage clinical research projects.
Education
- M.D. or M.D./Ph.D.
Required Experience and Skills
- Experience in industry or senior faculty in academia.
- Minimum 3 years of clinical medicine experience.
- Minimum 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; ability to function in a team environment.
- Provide expert opinion internally and externally on relevant scientific questions within their responsibility.
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 Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). The application deadline is stated on the posting.
Role Responsibilities
- Plan clinical trials based on the 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 safety/efficacy decisions and submissions/publications (e.g., new drug applications, clinical study reports, publications).
- Participate in internal and internal/external research project teams relevant to development of new compounds and further study of marketed compounds.
- Support business development assessments of external opportunities.
The Clinical Director May
- Engage with other functional areas to support study execution.
- Work with cross-functional experts (commercialization, regulatory affairs, statistics, manufacturing) to manage clinical development projects.
- Help ensure colleagues are informed of progress of company and competitor studies.
- Provide expert opinion internally and externally on scientific questions within their responsibility.
Scientific knowledge responsibilities
- Maintain awareness of scientific developments and research methodologies in their expertise.
- Identify strong investigators to support drug development.
- Establish communications with prominent clinical investigators.
- Attend appropriate scientific meetings.
To accomplish these goals, the Clinical Director may
- Author detailed development documents, presentations, budgets, and position papers.
- Facilitate collaborations with external researchers worldwide.
- Travel ~20% to manage clinical research projects.
Education
- M.D. or M.D./Ph.D.
Required Experience and Skills
- Experience in industry or senior faculty in academia.
- Minimum 3 years of clinical medicine experience.
- Minimum 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; ability to function in a team environment.
- Provide expert opinion internally and externally on relevant scientific questions within their responsibility.
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 Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). The application deadline is stated on the posting.