Clinical Scientist/ Senior Clinical Scientist
ROLE AND RESPONSIBILITIES
Provides strategic input and development support for clinical plans and individual study protocols.
Writes or assists in writing 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.
Affixes to other team members in Clinical Development in the implementation and conduct of clinical trials, which includes but is not limited to review of enrollment packets, review of adverse events, and all other clinical data generated during conduct of the trial.
Affixes in Medical Monitor responsibilities.
Works closely with Data Management to ensure that all relevant clinical data is collected promptly and assists 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 before 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.
5+ 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 exceptional attention to detail.
- Works independently in an interdisciplinary, fast-paced, often changing environment.
- Committed to the values of integrity, accountability, transparency, and drive.