7 дней назад
Sr. Director/VP Clinical Development and Medical Monitoring
250 000 - 375 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr. Director/VP Clinical Development and Medical Monitoring (Clinical Development/Medical Monitoring): Leading Phase I–III clinical development strategies and medical monitoring for small-molecule therapies in inflammatory, metabolic, and cardiovascular diseases with an accent on clinical strategy, safety, regulatory requirements, and cross-functional execution. Focus on coordinating global clinical trials, managing CROs and pharmacovigilance activities, engaging FDA experts and KOLs, and delivering differentiated development programs.
Location: San Francisco Bay Area, based in Newark, California; in-office work required
Salary: $250,000–$375,000 per year, depending on qualifications and experience
Company
is a drug development company creating small-molecule therapeutics for inflammatory, metabolic, autoimmune, and cardiovascular diseases.
What you will do
- Lead Phase I–III clinical development strategies, life-cycle management, safety responsibilities, and scientific interactions.
- Manage ongoing clinical studies, timelines, budgets, and the day-to-day activities of clinical CROs.
- Track clinical research developments and organize data analysis for relevant products.
- Coordinate clinical medicine, operations, registration, pharmacovigilance, statistics, and cross-functional execution.
- Engage with FDA review experts, clinical KOLs, physician experts, investors, CROs, and internal research and commercial teams.
- Develop differentiated clinical strategies based on competitive markets and unmet patient needs.
Requirements
- Doctor of Medicine degree and a US medical license.
- At least 8 years of direct experience in pharmaceutical or biotech clinical development, including international drug development.
- At least 8 years at Director level or above in clinical development.
- Experience leading global Phase I, II, and III clinical trials and managing patient compliance.
- Experience developing inflammatory and cardiovascular drugs.
- Strong knowledge of ICH guidelines, FDA requirements, early research, drug discovery, clinical practice, statistics, and people management.
Culture & Benefits
- Strategic leadership role within the US clinical development team.
- Close collaboration with research, commercial, and executive functions.
- Salary and benefits comparable with peers in the US and China biotech industries.
- Equal opportunity employment.
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