Clinical Development Medical Director, GU (Oncology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: San Diego, California, United States; hybrid work requiring residence within commuting distance and on-site work an average of 2.5 days per week. Relocation assistance may be available based on eligibility and business needs.
Annual base salary: $239,900–$399,800, plus a 25% bonus target and eligibility for a share-based long-term incentive program.
Company
is a global pharmaceutical company developing medicines and conducting clinical research across multiple therapeutic areas.
What you will do
- Provide medical and scientific leadership for a Phase 3 oncology clinical trial in prostate cancer.
- Serve as the study Medical Monitor, overseeing medical review, eligibility consultation, protocol deviations, safety surveillance, and investigator guidance.
- Interpret efficacy, safety, patient-reported outcome, imaging, and other clinical data and translate findings into medical recommendations.
- Lead or contribute to protocols, investigator brochures, informed-consent documents, monitoring plans, clinical study reports, integrated summaries, and regulatory responses.
- Support regulatory strategy, health-authority interactions, governance meetings, inspection readiness, and risk-mitigation planning.
- Collaborate with clinical operations, clinical science, safety, biostatistics, regulatory affairs, medical writing, data management, and other cross-functional partners.
Requirements
- Permanent U.S. work authorization and authorization to work in the U.S. by any employer are required.
- U.S. work visa sponsorship, including TN, O-1, and H-1B sponsorship, is not available now or in the future.
- Primary medical degree such as MD, DO, MBBS, or MBChB, with at least 4 years of experience.
- At least 2 years of independent prescribing licensure after internship, house-officer, or foundation training.
- Clinical training and meaningful patient-care experience in oncology, plus clinical research or drug-development experience.
- Knowledge of clinical trial design, Good Clinical Practice, applicable ethical and regulatory requirements, and interpretation of complex clinical and safety data.
Nice to have
- At least 2 years of pharmaceutical or biotechnology industry experience.
- Board eligibility or certification in Medical Oncology, Hematology/Oncology, Urology, or a relevant specialty.
- Prostate cancer experience and experience supporting Phase 3 or registration-enabling oncology trials.
- Experience as a Medical Monitor, with radiographic endpoints, independent data-monitoring committees, or regulatory submissions.
- Experience with clinical study reports, integrated summaries, investigator brochures, protocols, and health-authority interactions.
Culture & Benefits
- Hybrid work within commuting distance of the San Diego work location.
- Participation in ’s Global Performance Plan with a 25% target bonus.
- Eligibility for a share-based long-term incentive program.
- Benefits include a 401(k) with company contributions, retirement savings contributions, paid vacation and holidays, caregiver and parental leave, medical leave, and medical, prescription, dental, and vision coverage.
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