10 часов назад
Associate Director, Clinical Study Management, EMEA/LATAM (Oncology)
183 000 - 220 500$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director, Clinical Study Management, EMEA/LATAM (Oncology): Overseeing global Phase I–IV clinical trials across EMEA and LATAM in oncology and other therapeutic areas with an accent on regulatory compliance, timelines, budgets, and study quality. Focus on leading cross-functional study teams, managing regional resources and vendors, and building Clinical Operations Study Management capabilities.
Location: Hybrid, with a minimum of 3 days per week onsite in either Jersey City, New Jersey, or Millbrae, California
Expected salary: $183,000–$220,500 per year, plus bonus and equity compensation.
Company
Therapeutics is a biopharmaceutical company developing treatments for life-threatening diseases through technology combining chemistry, engineering, computation, and biology.
What you will do
- Oversee execution of multicenter global clinical trials across EMEA and LATAM, including oncology studies and other therapeutic areas.
- Manage protocol deliverables, timelines, country commitments, regulatory requirements, budgets, forecasts, resources, and regional KPIs.
- Lead cross-functional study teams and coordinate with Clinical Operations, Clinical Research and Development, finance, legal, vendors, and clinical sites.
- Manage ancillary vendor relationships and performance against contract requirements for time, cost, quality, and compliance.
- Ensure accurate and timely study documentation across clinical, regulatory, safety, and finance systems, including Veeva TMF.
- Lead and hire regional Clinical Operations Study Management personnel across EMEA and LATAM as needed.
Requirements
- At least 10 years of related experience with a Bachelor’s degree, or 8 years with a postgraduate degree.
- Fluent English is required, including strong reading, writing, speaking, and stakeholder communication skills.
- In-depth knowledge of ICH-GCP, EMEA/LATAM guidelines, and relevant clinical research regulations.
- Experience managing Phase I–IV multicenter global clinical trials within timelines and budgets while maintaining quality and patient safety.
- Strong leadership, communication, collaboration, accountability, and independent working skills.
- Experience managing budgets, resources, headcount, processes, controls, productivity, quality, and project delivery.
Nice to have
- Ability to speak multiple EMEA/LATAM languages.
- Experience in oncology or neuroscience clinical operations.
Culture & Benefits
- 401(k) plan with company matching.
- Medical, dental, and vision insurance with substantial premium coverage.
- Mental health and wellness benefits.
- Weeklong summer and winter holiday shutdowns, generous paid time off, and holiday policies.
- Enhanced parental leave and life/AD&D insurance benefits.
- Daily subsidized lunch when working onsite.
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