Director (Principal Scientist), Clinical Research, Respiratory
About the role
The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Cardiovascular and Respiratory therapeutic area. The role may manage the entire cycle of clinical development for assigned studies, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
Responsibilities
- Plan clinical trials based on clinical development strategy, including designing and collaborating on operational plans
- Provide medical oversight and ensure the overall conduct of ongoing or new clinical trials for investigational or marketed drugs
- Analyze and summarize clinical findings to support decisions regarding safety and efficacy, new drug applications, clinical study reports, or publication
- Participate in internal and joint internal/external research project teams relevant to the development of new compounds and further study of marketed compounds
- Support business development assessments of external opportunities
- Engage with other functional areas to support study execution, collaborating with experts in commercialization, regulatory affairs, statistics, and manufacturing
- Ensure colleagues are informed of the progress of studies of the company’s and competitors’ drugs
- Provide expert opinion, internally and externally, on relevant scientific questions within the area of responsibility
- Maintain a strong scientific fund of knowledge by staying current with scientific developments, research methodologies, and identifying scientifically and operationally strong investigators
- Establish communications with prominent clinical investigators to assist in the evaluation of the company’s drugs
- Attend scientific meetings to maintain competency and awareness of research activities in the area of responsibility
- Author detailed development documents, presentations, budgets, and position papers for internal and external audiences
- Facilitate collaborations with external researchers worldwide
- Travel on company business approximately 20% of the time to manage clinical research projects
Requirements
- M.D. or M.D./Ph.D. required
- 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 and ability to function in a team environment
- Strong verbal and written communication and presentation skills
Preferred Experience and Skills
- Board Certified or Eligible in Pulmonology, Cardiology, or related discipline
- Preference for pediatric and/or adult care experience
- Prior specific experience in clinical research and prior publication
Required Skills
- Cardiology
- Clinical Development
- Clinical Research
- Clinical Trials
- Cross-Functional Teamwork
- Early Clinical Development
- Intellectual Curiosity
- Pulmonology
Preferred Skills
- Cardiovascular Diseases
- Clinical Studies
Pay
The salary range for this role is $255,800.00 – $402,700.00. An employee’s position within the salary range will be based on factors including relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Benefits
- Medical, dental, vision healthcare and other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays, vacation, and compassionate and sick days