Clinical Scientist

• 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
• Assist other team members in Clinical Development in the implementation and conduct of clinical trial which includes but not limited to 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)

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• PhD, PharmD, R.N, Nurse Practitioner or Physician Assistant required
• 3 years of biotech experience (oncology, dermatology or autoimmune disease)

PREFERRED SKILLS

• 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.