3 часа назад
Associate Director, Clinical Operations (Biotechnology)
190 000 - 210 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director, Clinical Operations (Biotechnology): Leading the operational execution of MAR001 clinical studies from study start-up through late-phase data delivery with an accent on CRO oversight, enrollment strategy, budget control, and GCP compliance. Focus on managing global phase 2–3 trials, mitigating operational risks, supporting regulatory submissions, and coordinating cross-functional teams across multiple time zones.
Location: South San Francisco, United States; full-time hybrid position with on-site work at least three days per week
Salary: $190,000–$210,000 per year
Company
is a clinical-stage biotechnology company developing therapies for genetically validated cardioendocrine diseases, including severe hypertriglyceridemia and acromegaly.
What you will do
- Provide strategic and operational oversight for MAR001 clinical studies and related program activities.
- Lead Study Management Teams and coordinate cross-functional execution of clinical trials.
- Oversee CROs and vendors, including selection, contracts, work orders, performance indicators, and governance meetings.
- Develop site engagement, subject recruitment, risk mitigation, and study implementation strategies.
- Support clinical trial design, program and study documentation, regulatory submissions, and inspection readiness.
- Manage study budgets, resource planning, operational improvements, and clinical SOP initiatives.
Requirements
- BA/BS or higher degree in a relevant scientific discipline.
- 10+ years of clinical research or clinical operations and organizational management experience in the pharmaceutical industry.
- Global phase 2–3 clinical trial experience, including experience across multiple time zones.
- Experience leading cross-functional teams and managing or mentoring staff.
- Experience managing program budgets and negotiating and overseeing CRO and vendor contracts.
- In-depth knowledge of clinical research regulations and guidelines, including ICH-GCP, with strong communication and organizational skills.
Nice to have
- Biotechnology or small-pharma experience.
- Experience across phase 1–3 clinical development.
- Global clinical trial research experience.
Culture & Benefits
- Collaborative, tight-knit environment with contributions valued across all levels.
- Hands-on work alongside colleagues to understand challenges and drive results.
- Dynamic setting with opportunities to address new operational challenges and support company growth.
- Competitive compensation commensurate with experience, qualifications, and responsibilities.
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