Manager, Clinical Science

Your Role:
- Contribute to the design of clinical studies with the Medical Lead and Clinical Development team.
- Lead and/or contribute to protocol development with medical writing; translate protocol concepts into executable protocols.
- Drive medical contributions for annual updates of IB and DSUR with cross-functional teams.
- Support Medical Leads to answer regulatory queries and contribute to study-related submissions.
- Perform medical data review and analysis; review protocol deviations to identify causes and appropriate resolutions.
- Contribute to the design of electronic case report forms (eCRFs) to ensure accurate data capture per protocol.
- Support data cleaning with medical interpretation and analyses for regulatory submissions, data disclosure, and scientific publications.
- Monitor real-time study data to ensure integrity; work with clinical operations to address protocol questions and site conduct issues.
- Review/summarize literature for competitive intelligence; author/review manuscripts, abstracts, posters, etc.
- Manage communication and build collaborative relationships with key internal/external stakeholders (e.g., experts and investigators).

Your Background:
- PhD/MS/PharmD/BSN in relevant life sciences field; 2 years of pharmaceutical/biotech experience.
- Knowledge of the clinical development process and ability to understand study phases and design principles.
- Thorough understanding of ICH, GCP, and applicable regulatory requirements.
- Early/late-phase development and oncology experience preferred.
- Strong interpersonal, organizational, planning, communication, and writing skills.
- Ability to prioritize multiple tasks; team player; flexible; hands-on.
- Ability to influence and drive decision-making in multi-disciplinary teams.