6 дней назад
Associate Director, Clinical Operations Study Lead
165 000 - 200 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Clinical Operations Study Lead (Clinical Trials): Translating clinical strategies into operational plans and leading clinical trials across all phases with an accent on CRO and vendor oversight, cross-functional execution, and compliance with ICH GCP and local regulations. Focus on initiating complex studies, aligning timelines, budgets, priorities, and quality requirements, and coordinating international trial operations with up to 20% travel.
Location: Waltham, Massachusetts, United States; onsite
Salary: $165,000–$200,000 USD base pay annually
Company
is a clinical-stage biotechnology company developing oligonucleotide therapeutics for genetically driven neuromuscular diseases.
What you will do
- Translate clinical strategies into operational plans aligned with clinical development plans.
- Initiate and lead clinical trials across all phases.
- Oversee contract research organizations and other clinical trial vendors.
- Collaborate cross-functionally on clinical operations strategy and related initiatives.
- Align study execution with project priorities, timelines, budgets, and quality requirements.
- Ensure study conduct follows applicable regulations, ICH GCP guidelines, local requirements, and company policies and standard operating procedures.
Requirements
- Experience leading one highly complex or multiple medium-complexity clinical studies.
- Knowledge of ICH GCP guidelines, local regulatory requirements, and clinical operations procedures.
- Ability to oversee CROs and vendors and coordinate cross-functional clinical operations activities.
- Ability to travel internationally, with travel expected to be up to 20%.
- Availability to work onsite in Waltham, Massachusetts.
Culture & Benefits
- Work on therapeutics designed to improve function for people living with genetically driven neuromuscular diseases.
- Contribute to clinical programs in Duchenne muscular dystrophy and myotonic dystrophy type 1, alongside preclinical programs in other muscular dystrophies and Pompe disease.
- Base compensation is provided within the stated annual salary range, with individual pay determined by education, experience, job-related knowledge, and demonstrated skills.
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