2 дня назад
Director Clinical Trial Management Program Operations Leader (Biotech)
205 000 - 341 600$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director Clinical Trial Management Program Operations Leader (Biotech): Leading operational strategy and delivery for complex clinical programs with an accent on study quality, timelines, budgets, resources, and vendor governance. Focus on forecasting clinical trial management capacity, mitigating operational risks, supporting regulatory inspections, and coordinating cross-functional clinical development teams.
Location: US - Armonk, Warren or Cambridge; hybrid with 3 days in the office
Salary: $205,000–$341,600 annually
Company
is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.
What you will do
- Lead operational strategy and overall delivery for complex clinical programs.
- Oversee program quality, timelines, budgets, resources, and study team performance.
- Provide operational input into clinical study concepts, feasibility assessments, protocol design, study startup, and study conduct.
- Drive operational decisions, monitor KPIs, and implement risk mitigation strategies.
- Lead vendor selection, CRO oversight, governance activities, and partner meetings.
- Ensure inspection readiness and coordinate cross-functional support for regulatory authority inspections.
Requirements
- Bachelor's degree; an advanced degree may be considered in lieu of proven experience.
- At least 12 years of relevant experience, including at least 8 years in clinical operations.
- Knowledge of applicable regulations, ICH/GCP, and standard operating procedures.
- Experience leading complex clinical programs and managing operational strategy, budgets, timelines, and resources.
- Experience forecasting and allocating Clinical Trial Management resources and managing CROs, vendors, and external partners.
- Experience leading staff recruitment, performance management, coaching, mentoring, training, and compliance activities.
Culture & Benefits
- Hybrid work environment with regular office presence.
- Inclusive culture and equal employment opportunity.
- Benefits may include annual bonuses, equity awards, retirement benefits, 401(k) matching, health and wellness programs, insurance, paid time off, and family support benefits.
- Reasonable accommodations are available during the recruitment process where required.
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