Job Summary
Clinical Development Senior Medical Director (atirmociclib) - individual contributor supporting clinical trial(s) and leading clinical development subteams to meet scientific, ethical, and regulatory standards.
Responsibilities
- Conduct medical monitoring: eligibility assessment, data review, safety monitoring.
- Lead peer-to-peer interactions with investigators.
- Act as point of contact for clinical issues between study team, investigators, ethics/steering committees, and regulatory authorities.
- Lead and contribute to development/maintenance of clinical trial and regulatory documents with Clinical Scientist and cross-functional teams.
- Provide clinical development leadership across multiple study teams.
- Serve as Clinical Development Lead on subteams, including Marketing Authorization Applications.
- Collaborate with Global Development Team to create/refine development strategies.
- Represent the company in external engagements/joint collaborations.
- Review and interpret clinical data with Clinical Scientists; communicate key findings/implications to internal/external stakeholders.
- Stay current on latest literature/guidelines to advise and drive clinical development plans.
Basic Qualifications
- Primary medical degree (MD/DO/MBBS/MBChB) from a recognized institution.
- 4+ years biopharmaceutical clinical research and development experience.
- Medical license to prescribe independently for at least 2 years post internship/house officer/foundation.
Preferred Qualifications
- Board certified/eligible in oncology (preferred).
- Breast oncology experience (2+ years).
- Late-phase clinical development experience (preferred).
Additional Requirements/Work Conditions
- Travel to scientific conferences/meetings several times per year.
- Hybrid role: live within commuting distance; work on-site ~2.5 days/week.
Clinical Development Senior Medical Director, Breast Oncology in bothell at Unknown Company
This position is listed as internship and hybrid.