Clinical Operations Director
3 days ago
Structure Therapeutics is seeking a seasoned Director to lead Clinical Operations Process Improvement and Vendor Oversight. This pivotal role will ensure adherence to regulatory requirements, standards, and internal policies within the clinical operations department.
Key Responsibilities- Develop and implement comprehensive compliance strategies, policies, and procedures for clinical operations in alignment with regulatory standards and company objectives.
- Provide guidance and support to clinical operations teams to ensure compliance with relevant regulations, including Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, and applicable laws.
- Conduct regular oversight visits, evaluate compliance effectiveness, identify areas for improvement, and communicate clear, actionable recommendations.
- Collaborate with internal stakeholders to develop and deliver compliance training programs for the clinical operations staff.
- Lead investigations into compliance issues, deviations, and complaints, and implement corrective and preventive actions.
- Serve as a subject matter expert on matters related to process improvement and investigational site/clinical service provider oversight during internal and external audits, inspections, and regulatory interactions.
- 10-12 years of experience in clinical operations, regulatory compliance, GCP Quality, or related roles within the pharmaceutical or biotechnology industry, including 2 years of experience in FDA, EMA, or ICH-regulated clinical research.
- Strong understanding of regulatory requirements and industry standards related to clinical operations.
- Excellent leadership and decision-making skills with the ability to influence and drive change.
- Exceptional analytical and problem-solving capabilities to identify compliance risks and develop effective solutions.
- Proven track record of effectively managing compliance programs within Clinical Operations and initiatives within a regulated environment.
Structure Therapeutics offers a competitive salary range of $213,000 - $255,000 + bonus + equity + benefits. The company determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education, and training.
This is a hybrid role that will require 3 days in the office (2 core days, 1 flex day). The target salary range for this full-time role is $213,000 - $255,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education, and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.
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