Director, Clinical Operations Process Improvement and Vendor Oversight

$213,000 - $255,000/Yr

Structure Therapeutics - South San Francisco, CA

Full-time - Director

Hybrid - South San Francisco, CA

Professional, Scientific, and Technical Services

About the position

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 Development Operations (CDO) department. This position will oversee the development, implementation, and maintenance of CDO 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 CDO activities, focusing on clinical study delivery within quality parameters. This role will report to the Sr. VP, Clinical Development Operations and may have direct reports. For local candidates, this is a hybrid role that will require 3 days in the office (2 core days, 1 flex day). If remote, you will be required to work in the SSF office one week/month.

Responsibilities

• Collaborate with Quality, Study Team, investigational sites, and clinical service providers to provide CDO quality oversight.
• In partnership with internal stakeholders, develop and implement comprehensive compliance strategies, policies, and procedures for CDO in alignment with regulatory standards and company objectives.
• Provide guidance and support to CDO 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 CDO 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.
• Define strategy and methodology for CDO risk issue tracking, analysis, resolution, and implementing operational quality improvements, to ensure inspection readiness within CDO.
• Provide strategy and oversight of clinical trial compliance in support of clinical study teams across different stages of development.

Requirements

• Strong understanding of regulatory requirements and industry standards related to CDO.
• 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 CDO 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.

Nice-to-haves

• APAC experience is a plus.
• Experience in supporting GCP inspection readiness activities and participated in regulatory authority inspections preferred.

Benefits

• Bonus
• Equity
• Comprehensive benefits package