Director, Clinical Research, Cardiovascular and Respiratory

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: 

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 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 [insert specialty] or related discipline

• Prior specific experience in clinical research and prior publication

Required Skills:

Allergy and Immunology, Cardiovascular Diseases, Clinical Development, Clinical Investigations, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Trials, Clinical Trial Support, Cross-Functional Teamwork, Drug Development, Medical Research, Pharmaceutical Development, Pulmonology, Regulatory Reporting, Regulatory Requirements, Research Methodologies

Preferred Skills:

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