We're looking for a candidate to fill this position in an exciting company.

• Per sponsor request, reviews and provides input for protocol development; interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints; interacts in a team approach to develop statistical and data management sections of the protocol; reviews the final protocol for clinical, safety and efficacy variables
• Functions as project team member
• Provides project team with training on therapeutic indication and/or treatment modality
• May provide study team with assistance in developing criteria for investigator site selection and networking for potential investigators for study participation, and aid in review and final selection
• Participates in subject recruitment and retention activities which may include per sponsor request individual calls to key opinion leaders, investigators and site staff, and participation in teleconference and virtual presentations
• Per sponsor request, presents protocol and/or safety reporting information at investigator meetings
• Develops project medical monitoring plan
• Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues
• Provides medical input into the development of study protocols, training materials, informed consent, Investigator Drug Brochures, analysis plan designs, clinical study reports, regulatory approval submissions
• Interacts with clients regarding drug development programs, study design and protocol development
• Reviews and provides medical and scientific input to new business proposals
• Participates in feasibility discussions relating to specific project proposals
• Supports business development activities with proposal development and sales presentations

• Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus
• Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment
• Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities
• Excellent oral and written communications skills as well as interpersonal skills are essential
• Current or prior license to practice medicine; board eligibility require/board certification preferred
• 10 years' experience relevant to drug development and clinical research, including 3-5 years of biopharmaceutical industry, academic, and/or clinical practice experience