Position Summary:
- Senior Clinical Scientist on a multi-disciplinary Clinical Development Program, providing clinical expertise to monitor, track, and analyze subject data in Phase 1β3 studies. Partners with the Medical Lead and teams including DMPK, Clinical Operations, Biometrics, Pharmacovigilance, and Medical Affairs.
Responsibilities:
- Monitor, track, and analyze clinical trial subject data; collaborate with investigators, CRO medical monitors, Clinical Operations, and Biometrics.
- Regularly review safety and efficacy data for events of interest; review laboratory/safety parameters, patient profiles, listings, summary tables, and coded terms.
- Align scientific content and program strategy with clinical leads/medical directors.
- Author/review clinical/regulatory documents (protocols/amendments, study reports, IBs/ICFs, training materials, medical monitoring plans, SAP/DM plans, eCRFs and guidelines, charters, manuals).
- Respond to investigator scientific/protocol questions (with Medical Monitors/Medical Lead).
- Contribute to safety narratives, manuscripts, presentations; support regulatory submissions/Q&A.
- Support safety committee/DSMB-DMC preparations and presentations.
- Review protocol deviations; participate in database lock activities and internal data management meetings.
- Contribute to regulatory document sections and collaborate with Medical Affairs/Patient Advocacy.
Required Qualifications/Skills:
- MD/PhD/PharmD/MPH/MSN/RN with 8β10 years industry experience and 3β5 years clinical research in biopharma clinical development.
- Knowledge of FDA/EMA, Good Clinical Practice, ICH, and clinical drug development.
- Strong analytical/search skills; collaborative interpersonal skills; high integrity.
- Software: Windows; MS Office (Outlook, Word, Excel, PowerPoint).