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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 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.

Essential Duties and 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.
• This role is responsible for defining 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.

Education

• Bachelor's degree in a technical discipline; advanced degree preferred.

Experience

• 10-12 years of experience in clinical operations, regulatory compliance, GCP Quality, or related roles within the pharmaceutical or biotechnology industry, CRO, or investigational site, including 2 years of experience in FDA, EMA, or ICH-regulated clinical research. APAC experience is a plus.
• ICH/GCP expert with a strong understanding of FDA and EMEA regulations related to clinical development
• Strong understanding of drug development and clinical trial execution including cross functional areas involved in clinical trials
• Experience in supporting GCP inspection readiness activities and participated in regulatory authority inspections preferred
• Previous experience that provided the knowledge, skills and abilities to perform the expectations outlined in this job description

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.