2 дня назад
Clinical Development Executive Medical Director (Oncology)
274 000 - 456 600$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Development Executive Medical Director (Oncology): Defining and executing the clinical development strategy for Enfortumab vedotin with an accent on trial design, cross-functional leadership, safety, and regulatory submissions. Focus on leading the Global Development Team, interpreting clinical data, guiding health-authority interactions, and making complex development and dose-selection decisions.
Location: Hybrid role in Bothell, Washington, United States; permanent U.S. work authorization required.
Annual base salary: $274,000–$456,600, plus a 30% bonus target and eligibility for a share-based long-term incentive program.
Company
is a pharmaceutical company developing medicines and conducting clinical research across therapeutic areas.
What you will do
- Define and execute the clinical development strategy and plan for Enfortumab vedotin in the GU therapeutic area.
- Lead the product-specific Global Development Team and coordinate regulatory, statistical, safety, clinical pharmacology, and external stakeholder input.
- Oversee trial design, execution, protocols, amendments, investigator brochures, clinical study reports, and delivery of trial results.
- Evaluate, interpret, report, present, and publish clinical study data while guiding safety and clinical decisions.
- Lead clinical content preparation for NDA, MAA, IND, sNDA, labeling, and other regulatory submissions.
- Lead or contribute to health-authority meetings, regulatory responses, and appropriate business-development due diligence.
Requirements
- Medical degree or advanced degree with relevant clinical or industry experience.
- 7+ years of industry experience and 5+ years leading diverse teams.
- Prior management responsibility for medical directors or clinical scientists.
- Experience across clinical development phases and oncology drug classes.
- Ability to travel globally and work outside typical hours when required for other time zones or time-sensitive business needs.
- Permanent authorization to work in the United States; U.S. work visa sponsorship is not available.
Nice to have
- Board certification or eligibility in oncology or an equivalent qualification.
- Experience leading NDA, BLA, or MAA submissions.
Culture & Benefits
- Hybrid work location with occasional global travel.
- Relocation assistance may be available based on business needs and eligibility.
- Comprehensive medical, prescription drug, dental, and vision coverage.
- 401(k) matching contributions and an additional retirement savings contribution.
- Paid vacation, holidays, personal days, caregiver and parental leave, and medical leave.
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