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Associate Director Clinical Operations Leader
2 months ago
An Associate Director Program Operations Leader is responsible for leading and managing complex programs in Clinical Trial Management (CTM). The successful candidate will oversee clinical operations activities and decisions, ensuring quality, timelines, and budgets are met in accordance with applicable regulations, ICH/GCP regulations, and company Standard Operating Procedures (SOPs).
Key Responsibilities:- Lead clinical program(s) status and issues, proactively communicating progress, risks, issues, or changes that may impact quality, timelines, and/or budget.
- Ensure timely delivery of quality operational deliverables and maintain consistency of process and approaches across clinical study teams within the clinical program(s).
- Drive decision-making and integrate all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation.
- Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress.
- Provide proactive creation and implementation of risk mitigation strategies.
- Develop innovative and flexible operational solutions and options to cross-functional and development teams.
- Drive the strategy and oversight for vendor selection and management within a clinical program(s).
- Manage Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts.
- Identify and recommend changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development.
- Ensure inspection readiness throughout the clinical program lifecycle and lead cross-functional teams for Regulatory Authority Inspections.
- Direct supervision of CTM staff, including work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
- May require up to 25% travel.
- CTM Leadership Team
- Vendor Governance Committee(s)
- Clinical Operations Review Meeting(s)
- Development Team(s)
- Clinical Compliance Meeting(s)
- Strategy Review Meeting(s)
Cross-functional interfaces include key clinical and regulatory functional area leads, project management, medical directors, and analytical skills with a data-driven approach to planning, executing, and problem-solving.
A minimum of a Bachelor's degree and 12 years of relevant industry experience, with 8 years within the function, is required. We offer an inclusive and diverse culture with comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.