Senior Medical Director

Responsibilities:
- Assist in design, author/review clinical study synopses, protocols, amendments, study reports, and related documents.
- Act as a medical monitor for assigned studies.
- Discuss study design with investigators and key opinion leaders.
- Provide clinical input for protocol monitoring guidelines and analysis plans.
- Lead clinical database design, data collection/cleaning, and clinical interpretation of study data.
- Track emerging efficacy/safety; inform Clinical Development of changes in efficacy/safety and risk-benefit profiles.
- Contribute to clinical sections of regulatory documents (e.g., INDs, IND annual reports, Investigator’s Brochures, CRFs, informed consent forms, SAPs, data management edit checks, labeling).
- Lead/assist publications (abstracts, manuscripts, slides).
- Collaborate to identify/evaluate/monitor vendors and trial conduct/status.
- Assist with database finalization, result reviews/interpretation, and CSR support.
- Assist with investigator meetings and Advisory Boards; oversee vendor activities/deliverables.
- Present study results to the medical/scientific community.

Qualifications/Required:
- MD with solid tumor clinical trials experience; breast carcinoma experience preferred.
- 8–10 years clinical development experience in pharma/biotech.
- Phase I–III trial experience (Phase 3 preferred).
- Knowledge of clinical trial design/methodology/statistics; IND/NDA process; GCP/ICH.
- Strong written/verbal communication; ability to work with cross-functional teams and medical/scientific stakeholders; strong organizational/time management and computer/software skills.

Preferred:
- Collaborative, team-oriented leadership; relationship-building; strong values-based leadership; experience working with CROs.

Benefits (as stated):
- Annual performance incentive bonus; new hire equity package; medical/dental/vision insurance; 401k match; PTO; paid holidays.