Clinical Director (Principal Scientist), Clinical Research, Immunology - Rheumatology

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.

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

Preferred Skills:

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