Position Overview
Senior / Principal Clinical Scientist, Clinical Development
- Design, execute, and interpret multiple oncology clinical trials.
- Partner with cross-functional teams (clinical operations, regulatory affairs, R&D) to advance multiple clinical programs.
Responsibilities
- Oversee clinical trial execution; ensure scientific and regulatory rigor.
- Design clinical trial protocols, informed consent forms, and other study documents.
- Collaborate with principal investigators, KOLs, and trial sites; serve as Lead Clinical Scientist for multiple trials.
- Support data generation/validation (CRF design; clinical data review/query resolution).
- Contribute to clinical study reports, regulatory submissions, and publications.
- Review site/CRA training materials; support SIV/Investigator meeting presentations.
- Support study committee activities (e.g., DMC).
- Perform site-facing training and respond to clinical questions.
- Participate in development plan/timeline strategy.
- Present data to stakeholders (scientific advisory boards, regulatory agencies).
- Mentor junior team members; potential to manage direct reports.
Qualifications
- PhD, MD, PharmD, MS, or equivalent in life sciences.
- 2+ years in clinical science/research (clinical development required); biopharma/oncology preferred.
- Strong leadership, project management, and communication skills.
- Travel may be required.
Knowledge/Skills
- Drug development process, study design, and clinical operations experience.
- Clinical trial data analysis tools/software.
- Data review, trend identification, and data interpretation.
- Regulatory knowledge (GCP, ICH, FDA).
- Analytical, organizational, communication skills; fast-paced collaboration; problem-solving and attention to detail.