Clinical Scientist

ROLE AND RESPONSIBILITIES

• Provides strategic input and development support for clinical plans and individual study protocols
• Writes or assists in writing of clinical plans and study protocols and protocol amendments in close collaboration with VP, Clinical Development
• Writes or assists in writing Investigator Brochures, DSURs and other regulatory documents
• Assists other team members in Clinical Development in the implementation and conduct of clinical trials
• Includes review of enrollment packets, review of adverse events and all other clinical data generated during conduct of trial
• Assist in Medical Monitor responsibilities
• Work closely with Data Management to ensure that all relevant clinical data is collected in a timely manner and assist with cleaning of data listings
• Participates in the development of clinical operating guides and maintains secure study files
• Reviews results of these evaluations with appropriate management prior to implementation
• May require travel to field sites and scientific meetings
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
• Determines methods and procedures on new assignments
• May coordinate activities of other personnel (team lead)

REQUIREMENTS

• PhD, PharmD, R.N, Nurse Practitioner or Physician Assistant required
• 3+ years of biotech experience (oncology, dermatology or autoimmune disease)
• Excellent teamwork and collaboration skills
• Proficient with Microsoft Office
• Able to build effective working relationships throughout the organization internally and externally to achieve goals
• Flexibility and willingness to solve problems that fall outside of immediate area of expertise
• Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail
• Work independently in an interdisciplinary, fast-paced, often changing environment
• Committed to the values of integrity, accountability, transparency, and drive.