Director, Clinical Development Scientist
About The Position
Lead a cross functional team in the design and execution of a clinical study and provide input into the global clinical development plans and strategy for a therapeutic area. You will be responsible for leading the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents. You will also mentor and develop Clinical Development Scientists in these areas, participate in Investigator meeting planning and execution and/or onsite initiation meetings. This role involves study execution including country and site selection, site training and startup and data monitoring, with expertise in data analysis and presentation. Depending upon specific expertise in translational science, may lead a translational sub team of the clinical team. You will engage with clinical investigators nonclinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define clinical and therapeutic area strategy. You will also engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies. Where appropriate, serve as the SME for identification, translation, inclusion, implementation and reporting. Maintain awareness of internal and external developments (scientific, clinical, industry, and regulatory) that could impact the development plan, including attendance at major conferences, participation in competitive intelligence activities, and periodic literature review. Evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.
Requirements
- PhD, PharmD or equivalent degree OR equivalent years of experience
- History of industry or academic clinical or basic science research
- Excellent written / oral communication skills
- Ability to think strategically
- Attention to detail
Responsibilities
- Lead preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
- Mentor and develop Clinical Development Scientists in preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents
- Participate in Investigator meeting planning and execution and/or onsite initiation meetings
- Study execution including country and site selection, site training and startup and data monitoring; expertise in data analysis and presentation.
- Depending upon specific expertise in translational science, may lead a translational sub team of the clinical team.
- Engage with clinical investigators nonclinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define clinical and therapeutic area strategy.
- Engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
- Where appropriate, serve as the SME for identification, translation, inclusion, implementation and reporting.
- Maintain awareness of internal and external developments (scientific, clinical, industry, and regulatory) that could impact the development plan, including attendance at major conferences, participation in competitive intelligence activities, and periodic literature review
- Evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
