Director, Clinical Operations (Pharmaceuticals)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Director, Clinical Operations (Pharmaceuticals): Leading the planning, execution, and oversight of company-sponsored clinical trials with an accent on operational excellence and study strategy. Focus on guiding cross-functional teams, managing complex clinical programs, and ensuring strict regulatory compliance.
Location: Must be located in either the US or Denmark
Company
A pharmaceutical company focused on delivering high-quality clinical programs and drug development excellence.
What you will do
- Lead the operational design and conduct of clinical studies from protocol feasibility through database lock and submission.
- Manage direct and indirect reports, including administrative budget oversight and resource allocation.
- Oversee the selection, contracting, and performance monitoring of external service providers (CROs, laboratory vendors).
- Ensure all trials are conducted in strict compliance with GCP, ICH regulations, and company quality standards.
- Maintain inspection-ready Trial Master Files (TMF) and oversee subject recruitment and retention strategies.
- Collaborate cross-functionally to prepare study-specific documents and support regulatory submissions.
Requirements
- Bachelor of Science degree in Nursing, Pharmacy, or a scientific field.
- 6+ years of pharmaceutical industry experience in clinical operations (with a Master’s/Doctorate) or 8+ years (without an advanced degree).
- Must be located in the US or Denmark.
- Proven ability to manage large, complex clinical trials and contribute to study design.
- Proficiency in GCP and ICH regulations.
Nice to have
- Knowledge in Diabetes, Endocrinology, or Weight Management areas.
- Previous leadership experience.
- Experience with vendor management and supporting regulatory submissions.
Culture & Benefits
- High-impact leadership role reporting to the VP of Clinical Excellence.
- Culture based on accountability, collaboration, and high performance.
- Strong emphasis on people development through coaching and mentoring.
- Inclusive and respectful work environment that values diverse perspectives.
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