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Clinical Director (Principal Scientist), Clinical Research, Immunology - Rheumatology
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#31885
Remote / WFH
Merck
Job Description
Job Description:
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. Our company's Immunology 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:
Specifically, the Clinical Director may be responsible for:
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; and
Assist the team in ensuring that other colleagues are informed of the progress of studies of our company and competitors' drugs, and
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 their 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 their 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 their competency and to maintain awareness of research activities in their 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
Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility.
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. Our company's Immunology 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:
Specifically, the Clinical Director may be responsible for:
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; and
Assist the team in ensuring that other colleagues are informed of the progress of studies of our company and competitors' drugs, and
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 their 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 their 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 their competency and to maintain awareness of research activities in their 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
Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility.
