Sr. Director, Clinical Operations
- Posted: over a month ago
Amador Bioscience (AmadorBio) is a Translational & Clinical Pharmacology CRO providing global-standard services in quantitative clinical pharmacology, GLP/GCLP bioanalysis, clinical research, and regulatory filing to leading biopharmaceuticals companies in the world. Our clients include multinational pharmaceuticals and mid- and small-size biotech companies.
Sr. Director/Executive Director leads operations across all future clinical sites to ensure that operational and that the organization’s objectives are met. The incumbent is accountability for clinical quality of care, patient and external stakeholders’ satisfaction and staff leadership.
Role and Responsibilities
- Responsible for developing strategy, and methodology of clinical operations programs.
- Responsible to ensure clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready.
- Oversee the budgets and timelines and support implementation using local relevant local regulations and international ICH-GCP guidelines.
- Provide operational and strategic input on training materials, program specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers).
- Drive site selection and subject recruitment programs to deliver study enrollment targets.
- Partner and liaise with internal team members across the globe, which includes: technical leads in multiple functional areas, project management, and regulatory affairs.
Qualifications and Education Requirements
- 15+ years’ experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO.
- Ability to look for and champion more efficient and effective methods/processes of delivering Clinical operations focusing on key performance metrics around reliability, efficiency, cost and quality.
- Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required. Experience leading global trials - outside the US/UE/ASIA/Americas is preferred.
- Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, and budget management.
- Demonstrated experience in successful planning and implementation of clinical trial operations.
- Experience developing clinical protocols, SOPs, Clinical Study Reports, and other documents to support New Drug Application (NDA) on time, within budget, and in compliance.
- Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
AMADOR BIOSCIENCE INC
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