Director, Clinical Research, Cardiovascular and Respiratory
Merck, Rahway, New Jersey, us, 07065
Clinical Director (Principal Scientist)
Job Description
The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the [insert name of TA] therapeutic area. Our company's [insert name of TA] medicines span all phases of clinical development (pre‑clinical to post‑licensure). The Clinical Director may manage the entire cycle of clinical development for their assigned studies, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
Role Responsibilities
Planning clinical trials (designing, collaborating on operational plans, etc.) based on the clinical development strategy
Medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs
Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication
Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds
Supporting business development assessments of external opportunities
The Clinical Director May
Actively engage with other functional areas in support of study execution
Work closely with a cross‑functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
Assist the team in ensuring that other colleagues are informed of the progress of studies of our company and competitors' drugs
Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility
The Clinical 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 Clinical 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
Education
M.D. or M.D./Ph.D.
Required Experience And Skills
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 Experience And Skills
Board Certified or Eligible in Cardiology, Pulmonology or related discipline
Strong preference in pediatric and/or adult care
Prior specific experience in clinical research and prior publication
Required Skills Adult Care, Cardiovascular Diseases, Clinical Development, Clinical Investigations, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Trials, Clinical Trial Support, Cross‑Functional Teamwork, Drug Development, Medical Research, Pediatric Cardiology, Pediatric Medicine, Pharmaceutical Development, Pulmonology, Regulatory Reporting, Regulatory Requirements, Research Methodologies
Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE
Requirements (EEO Statement) 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other U.S. State Acts
Job Posting End Date 01/30/2026
#J-18808-Ljbffr
Job Description
The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the [insert name of TA] therapeutic area. Our company's [insert name of TA] medicines span all phases of clinical development (pre‑clinical to post‑licensure). The Clinical Director may manage the entire cycle of clinical development for their assigned studies, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
Role Responsibilities
Planning clinical trials (designing, collaborating on operational plans, etc.) based on the clinical development strategy
Medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs
Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication
Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds
Supporting business development assessments of external opportunities
The Clinical Director May
Actively engage with other functional areas in support of study execution
Work closely with a cross‑functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
Assist the team in ensuring that other colleagues are informed of the progress of studies of our company and competitors' drugs
Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility
The Clinical 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 Clinical 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
Education
M.D. or M.D./Ph.D.
Required Experience And Skills
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 Experience And Skills
Board Certified or Eligible in Cardiology, Pulmonology or related discipline
Strong preference in pediatric and/or adult care
Prior specific experience in clinical research and prior publication
Required Skills Adult Care, Cardiovascular Diseases, Clinical Development, Clinical Investigations, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Trials, Clinical Trial Support, Cross‑Functional Teamwork, Drug Development, Medical Research, Pediatric Cardiology, Pediatric Medicine, Pharmaceutical Development, Pulmonology, Regulatory Reporting, Regulatory Requirements, Research Methodologies
Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE
Requirements (EEO Statement) 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other U.S. State Acts
Job Posting End Date 01/30/2026
#J-18808-Ljbffr