Clinical Director (Principal Scientist), Clinical Research, Immunology - Rheumatology
Merck
4 months ago
Remote friendly (North Wales, PA)
United States
Clinical Research and Development
The Clinical Director (Principal Scientist) plans and directs clinical research activities involving new or marketed medicines in the Immunology therapeutic area, and may manage end-to-end clinical development (study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication).
Role Responsibilities
- Plan clinical trials (design and collaboration on operational plans) 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 support new drug applications, clinical study reports, or 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.
The Clinical Director 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 keep colleagues informed of progress of company and competitor drug studies.
- Provide expert opinion (internally and externally) on relevant scientific questions.
Maintain scientific knowledge by
- Staying current on scientific developments and research methodologies.
- Identifying strong investigators to support development of company investigational and marketed drugs.
- Establishing communications with prominent clinical investigators.
- Attending appropriate scientific meetings.
To accomplish these goals, may
- Author development documents, presentations, budgets, and position papers for internal/external audiences.
- Facilitate global collaborations with external researchers.
- Travel ~20% of the time.
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 industry experience in drug development, or biomedical research experience in academia.
- Demonstrated record of scientific scholarship and achievement.
- Strong interpersonal skills and ability to function in a team environment.
Preferred Experience and Skills
- Board Certified or Eligible in Rheumatology (or related discipline).
- Prior clinical research experience 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 through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee).
Role Responsibilities
- Plan clinical trials (design and collaboration on operational plans) 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 support new drug applications, clinical study reports, or 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.
The Clinical Director 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 keep colleagues informed of progress of company and competitor drug studies.
- Provide expert opinion (internally and externally) on relevant scientific questions.
Maintain scientific knowledge by
- Staying current on scientific developments and research methodologies.
- Identifying strong investigators to support development of company investigational and marketed drugs.
- Establishing communications with prominent clinical investigators.
- Attending appropriate scientific meetings.
To accomplish these goals, may
- Author development documents, presentations, budgets, and position papers for internal/external audiences.
- Facilitate global collaborations with external researchers.
- Travel ~20% of the time.
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 industry experience in drug development, or biomedical research experience in academia.
- Demonstrated record of scientific scholarship and achievement.
- Strong interpersonal skills and ability to function in a team environment.
Preferred Experience and Skills
- Board Certified or Eligible in Rheumatology (or related discipline).
- Prior clinical research experience 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 through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if a current employee).