14 часов назад
Associate Director, Clinical Operations (Therapeutics/Oncology)
142 500 - 256 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director, Clinical Operations (Therapeutics/Oncology) (Clinical Trials/Oncology): Leading first-in-human through phase 4 clinical trials, CRO oversight, budgets, timelines, and cross-functional execution with an accent on oncology therapeutics, operational strategy, and GCP-compliant trial delivery. Focus on solving site activation, enrollment, monitoring, protocol deviation, inspection readiness, and vendor management challenges while mentoring clinical operations staff.
Location: Cambridge, Massachusetts, United States; 70% in-office and 30% flexible work model
Salary: $142,500–$256,500 per year, plus potential bonus, incentive compensation, or equity.
Company
develops mRNA-based therapeutics and vaccines using its mRNA technology, delivery, and manufacturing platforms.
What you will do
- Lead clinical trials from first-in-human through Phase 4 across the therapeutics and oncology portfolio.
- Develop clinical operations strategies and plans aligned with clinical development programs.
- Manage study budgets, timelines, resources, invoices, forecasting, and operational risks.
- Select and oversee CROs, vendors, clinical sites, and outsourced trial activities.
- Collaborate with Clinical, Regulatory, CMC, Biostatistics, Data Management, Finance, and Program Management teams.
- Provide oversight and mentorship to Clinical Trial Managers and Clinical Trial Associates.
Requirements
- BA/BS degree and 8–10 years of clinical trial or clinical program experience, including at least 4 years of independent trial management.
- Full clinical trial lifecycle experience, including start-up, conduct, and closure.
- Robust therapeutics and oncology experience; early clinical development and immuno-oncology experience are desirable.
- Experience with GCP inspections, audits, clinical documents, operational compliance, and regulatory requirements.
- Strong leadership, communication, organizational, collaboration, and problem-solving skills in biotech or pharmaceutical environments.
- Some travel is required.
Nice to have
- Advanced degree.
- Experience with hematologic malignancies.
- Experience building relationships with key opinion leaders.
Culture & Benefits
- Competitive healthcare and voluntary benefit programs.
- Fitness, mindfulness, and mental health resources.
- Family planning support, including fertility, adoption, and surrogacy benefits.
- Paid vacation, volunteer days, sabbatical, recharge days, and year-end shutdown.
- Savings and investment programs plus location-specific benefits.
- In-person collaboration supported by a 70/30 work model.
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