Key skills
Project ManagementMentoring
About this role
Role Overview
- Drive scientific planning, strategy and execution of Phase 1-4 clinical studies
- Collaborate with global, crossfunctional team members including clinical directors and study managers
- Responsible for the clinical/scientific execution of clinical protocol(s)
- Serve as the lead clinical scientist on the clinical trial team
- Collaborate with the Medical Writer on clinical/scientific and regulatory documents
- Partner with Study Manager on study deliverables
- Participate in the set up and design during study start up (e.g., database set up)
- Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations
- Build talent and capabilities of direct/indirect team members through proactive coaching, mentoring and development opportunities
- May include management of direct reports including assignment of resources, professional development, and performance management
- May serve as a subject matter expert and/or participate on process improvement teams.
Requirements
- Bachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +6 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree +2 years of pharmaceutical, clinical drug development, project management, and/or medical field experience
- Degree in life sciences, preferred
- Experience in conducting global clinical trials, including trial initiation through database lock
- Highly Preferred: experience in conducting clinical trials for Gastroenterology, Dermatology or Rheumatology, especially autoimmune or immune-mediated disorders
- Experience in developing protocols and study related documents for Immunology related clinical trials
- Experience with review of participant eligibility for trials (e.g., inclusion and exclusion criteria and prohibited/concomitant medications) with a high focus in Immunology related clinical trials
- Experience in performing medical monitoring in Immunology related clinical trials.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days