Associate Director, Field Monitoring Operations (Biotech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: Remote; Monday–Friday during standard business hours with manager-approved flexibility. Travel of up to 75% is required, with flexibility to work across various time zones.
Annual base pay: $195,500–$215,000 in national markets or $210,000–$230,000 in premium markets, including Los Angeles, San Diego, San Francisco, New York City, Chicago, and Boston. The position is also eligible for a discretionary bonus and equity award.
Company
is a publicly traded biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and infectious-disease treatments that harness the immune system.
What you will do
- Design, implement, and oversee monitoring strategies, including Risk-Based Quality Management and decentralized clinical trial approaches.
- Lead remote Clinical Research Associates and Managers while mentoring direct reports and supporting clinical study teams.
- Integrate remote, on-site, and decentralized monitoring with trial start-up, site activation, and study close-out.
- Coordinate with CROs, site investigators, and cross-functional leaders to translate strategy into actionable monitoring plans and optimize resources.
- Provide quality oversight, support inspection readiness, and maintain clinical operations SOPs aligned with modern risk-management frameworks.
- Drive process improvements, best-practice sharing, training, and operational excellence across multiple clinical studies.
Requirements
- Bachelor’s degree in life sciences, nursing, pharmacy, or a health-related field with 10+ years of progressive industry experience, or a master’s degree with 8+ years of experience.
- 6+ years of management experience leading clinical trial operations teams.
- Strong knowledge of clinical research, ICH E6(R3) Good Clinical Practices, regulatory requirements, and Risk-Based Quality Management.
- Experience driving cross-functional alignment, managing clinical monitoring activities, and overseeing trial quality.
- Excellent English verbal and written communication skills required.
- Proficiency with Microsoft Office, Veeva Clinical Vault, CTMS, and eTMF.
Nice to have
- Master’s degree in a relevant field.
- Experience working in a dynamic, fast-paced environment.
Culture & Benefits
- Collaborative environment with opportunities to work across different areas of the company.
- Professional development opportunities within a growing biotechnology organization.
- Medical, dental, and vision plan options, plus health and financial wellness programs.
- 401(k) retirement plan with company match, flexible spending accounts, life and disability insurance, and employee assistance programs.
- Paid time off, holidays, education savings support, legal services, identity theft protection, pet insurance, and employee discounts.
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