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, analysis, regulatory reporting, and publication.

• 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

• 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

• Maintaining awareness of scientific developments within the area of expertise, including new findings and 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 the field of interest
• Attending appropriate scientific meetings to maintain competency and awareness of research activities

• 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 percent of the time to manage future or ongoing clinical research projects

• M.D. or M.D./Ph.D.

• 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 in academia
• Demonstrated record of scientific scholarship and achievement
• Proven track record in clinical medicine and background in biomedical research
• Strong interpersonal skills and ability to function in a team environment
• Strong verbal and written communication and presentation skills

• Board Certified or Eligible in [insert specialty] or related discipline
• Prior specific experience in clinical research and prior publication

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

Current Employees apply HERE ($6687.htmld)
• Current Contingent Workers apply HERE ($4020.htmld)

US and Puerto Rico Residents Only:
Our company is committed to inclusion and provides accommodations during the application process if needed. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination. For more information about rights under U.S. law, please review the EEOC resources: EEOC Know Your Rights and related materials. Learn more about privacy…