- Collaborate with Quality, Study Team, investigational sites, and clinical service providers to provide clinical operational quality oversight.
- In partnership with internal stakeholders, 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 independently or with oversight Monitors, evaluate compliance effectiveness, identify areas for improvement, and communicate clear, actionable recommendations.
- Identify trends/best practices, and coordinate with functional groups to interpret and address updates to documents impacting clinical operations.
- 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.
- Foster a culture of ethical behavior, integrity, and accountability throughout the clinical operations organization.
- This role is responsible for defining strategy and methodology for Clinical Operations risk issue tracking, analysis, resolution, and implementing operational quality improvements, to ensure inspection readiness within Clinical Operations
- Provide strategy and oversight of clinical trial compliance in support of clinical study teams across different stages of development.
- 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. APAC experience is a plus.
- 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.
- Outstanding communication, project management and interpersonal skills to collaborate with diverse stakeholders and build relationships.
- Ability to prioritize and manage multiple projects simultaneously while maintaining attention to detail and meeting deadlines.
- Demonstrated commitment to fostering a culture of compliance, integrity, and continuous improvement.
- Able to monitor, track and act on quality and compliance metrics and trends.
- Experience leading Clinical Operations focused compliance initiatives.
- Excellent verbal and written communication skills, including the ability to convey complex information clearly and concisely.
- Strong interpersonal skills with the ability to collaborate effectively across different functional areas and levels of the organization.
- Demonstrated ability to build rapport, influence others, and drive change through effective communication and relationship-building.
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Director, Clinical Oversight Process Improvement and Vendor Oversight - South San Francisco, United States - Structure Therapeutics
Description
Job Description
Job DescriptionSalary:Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. #LIHybrid
POSITION SUMMARY
The Director, Clinical Operations Process Improvement and Vendor Oversight is a pivotal leadership role responsible for ensuring adherence to regulatory requirements, standards, and internal policies within the clinical operations department. This position oversees the development, implementation, and maintenance of Clinical Operations focused compliance programs, processes to mitigate risks, promote ethical practices and will collaborate closely with cross-functional teams to foster a culture of compliance, integrity, and continuous improvement in all clinical operations activities, focusing on clinical study delivery within quality parameters.
ESSENTIAL DUTIES AND RESPONSIBILITIES
REQUIREMENTS
Education
• Bachelor's degree in a technical discipline; advanced degree preferred.
Travel
· Up to 25%
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.
