Duties and responsibilities:
- Contribute to and/or lead the development of clinical protocols and other clinical documents, in close collaboration with cross-functional team members and external vendors
- Participate in activities related to protocol data review, medical monitoring, query resolution, and study conduct oversight
- Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies
- Provide scientific review of statistical analysis plans
- Support regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities
- Collaborate on the review, analysis, and interpretation of study results, including exploratory endpoints
- Collaborate with team members in Data Management activities such as development of eCRFs, edit checks, report development and database lock processes
- Assist in writing and providing scientific input, review, and edits of clinical study reports, Investigator Brochures, INDs, NDA annual reports, integrated medical reports, and other regulatory submissions.
- Support preparation of abstracts, manuscripts, presentations, and materials for external meetings as it relates to the assigned protocol(s) and/or clinical program
Qualifications include but not limited to:
- Doctorate degree (e.g. Pharm.D., Ph.D.) with 3+ years of experience in clinical development in the pharmaceutical/biotech industry, particularly in Phases II-III, 5+ years of experience for BS/MS degree.
- Prior dermatology drug development experience preferred
- Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
- Excellent written and oral communication skills
- Ability to multi-task and to work successfully in a lean, fast-paced, matrix team environment
- High level of organizational and project management skills.
Travel requirement approximately 5-10% based on protocol development stage and program needs