Clinical Scientist

Director or Senior Director

North Carolina, U.S. (Hybrid)

SUMMARY
The clinical scientist is a key member of the clinical development team for the planning, conduct, analysis, and reporting of clinical studies. This position is expected to work independently across functional teams to ensure the timely execution of the clinical development plan. Requires limited to minimal supervision from the medical director in the development of protocols, analysis of clinical trial data, literature searches, and summary of key data. Closely collaborates with Clinical Operations in the overall conduct and timely execution of clinical trials. Works in collaboration with other key stakeholders in the development of the clinical program strategy and other activities towards achieving corporate objectives.

Primary Job Responsibilities
Specific tasks/projects, skills, short and long-term objectives, management responsibilities, if any

  • Author key technical and clinical documents, including but not limited to, clinical study protocols, clinical study reports, investigator’s
    brochures, annual reports and clinical sections of regulatory submissions
  • In conjunction with clinical operations team, participate in selection of investigators, clinical sites, and vendors (including CRO)
  • Accountable for the clinical/scientific execution of the clinical protocol.
  • Accountable for the scientific aspects of the implementation and conduct of a clinical trial with both internal and external stakeholders
    (e.g., investigator meeting presentations, data review and summary, protocol deviation review, etc.)
  • Create and maintain clinical development plans to be aligned with Target Product Profile
  • Develop and perform clinical data review plans for clinical studies
  • Participate in and prepare presentations for scientific meetings such as DSMB, steering committees, scientific advisory boards, etc.
  • Builds relationships with external scientific and clinical thought leaders
  • Author abstracts and prepare posters for external presentation
  • Establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems (eCRF),
    and final reports
  • Coordinate efforts and collaborate with internal stakeholders (i.e., regulatory, translational, biostatistics, pharmacology/toxicology) to allow
    efficient execution of clinical studies.
  • Able to work independently as well as contribute as part of an interdisciplinary team
  • Maintain flexibility to meet deadlines and to respond to frequent and/or unexpected changes

Job and Level Requirements
Minimum education and experience required, also ideal but not required qualifications

  • BSN, MS, PhD, PharmD, or equivalent with clinical research experience. Advanced degree candidates preferred with strong scientific knowledge and skill set
  • ‪A minimum of 10+ years’ experience in the pharmaceutical industry, with minimum 5-8 years clinical development/clinical operations
    experience in oncology
  • Requires thorough understanding of the drug development process from pre-IND through registration and post-registration
  • Broad and solid understanding of functional areas of drug development, including but not limited to, preclinical, clinical operations, regulatory,
    pharmacovigilance, drug supply, and biometrics (including biostatistics and data management)
  • Candidates must possess highly effective communication skills and be fluent in the English language, both written and verbal.
  • Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing
    treatment paradigms in order to apply knowledge to support a robust overall clinical development strategy
  • Critical traits for success include strategic and proactive thinking, strong scientific and analytical skills, decisiveness, and the ability to
    perform as a respected team member and leader
  • Ability to work independently and to organize priorities and deliverables
  • The candidate should be detail-oriented, a self- starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced,
    small company environment.

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