Position Summary:
The Associate Director of Clinical Operations plays a pivotal role in leading clinical studies across all phases, ensuring efficient execution and compliance with regulatory standards. This senior-level position requires collaboration with cross-functional study teams, vendor management, and direct contributions to clinical development operations to drive study success in a dynamic, global environment.
Job Responsibilities
- Clinical Study Leadership: Lead and coordinate activities for assigned studies throughout all clinical trial phases - start-up, conduct, and close-out - ensuring alignment with corporate objectives and timelines.
- Operational Strategy & Execution: Work with leadership team to translate corporate strategies into operational plans within internal teams and external partners. Manage clinical study budgets, timelines, resource allocation, and vendor performance to ensure successful study delivery.
- Risk Management: Proactively identify and assess risks to study timelines, budget, and quality; develop and implement mitigation strategies in collaboration with stakeholders.
- Vendor Oversight: Manage relationships with clinical trial vendors, CROs, and sites to monitor progress, compliance with study protocols, GCP, and regulatory requirements. Oversee vendor deliverables and ensure quality standards.
- Regulatory and Documentation Management: Oversee the preparation, review, and finalization of all study-related documents including protocols, informed consent forms, feasibility assessments, study plans, and electronic data capture (EDC) tools. Contribute to regulatory submissions and responses to Ethics Committees and Health Authorities.
- Systems: Collaborate with DM to review Case Report Forms (CRFs). Participate actively in EDC, IRT User Acceptance Testing (UAT) and other systems as required by protocol to ensure data integrity and system readiness.
- Team Leadership & Development: May include line management responsibilities involving recruitment mentoring, career development, performance management, and talent retention for clinical operations staff. Foster a culture of accountability, continuous improvement, and collaborative problem-solving.
- Site & Investigator Engagement: Assist in the selection and qualification of clinical investigators and sites. Conduct site monitoring oversight and lead site issue resolution, including escalation when necessary.
- Safety & Compliance Oversight: Work with Cross functional Safety Review Committee meetings as required to support deliverables. Monitor data queries and ensure timely resolution.
- Cross-Functional Collaboration: Work closely with Preclinical, Biostatistics, Data Management, Clinical Supplies, Safety/PV, and Medical Affairs teams to ensure seamless study execution and IMP accountability, including sample management and study plan reviews.
- Meetings & Representation: Prepare and deliver presentations at investigator meetings and project team meetings. Act as a clinical operations representative at the project team level.
- Process Improvement & SOP Management: Update and maintain Standard Operating Procedures as assigned. Drive continuous improvement initiatives within clinical operations.
Qualifications:
- Bachelor's degree or higher in a scientific or health-related discipline. Advanced degrees preferred.
- Minimum of 8 years of clinical operations experience within a pharmaceutical, biotech, or CRO setting.
- At least 6 years in roles such as Clinical Research Associate (CRA), Senior CRA, or Clinical Trial Manager (CTM).
- Proven experience managing Phase I to III clinical trials and leading start-up activities.
- Strong knowledge of ICH-GCP guidelines, FDA, EMA, and other applicable global regulatory requirements.
- Experience leading global, multi-regional clinical trials, with a preference for Asia-Pacific expertise.
- Demonstrated ability to lead cross-functional teams and manage complex vendor relationships.
Desired Skills & Competencies:
- Analytical mindset with strong problem-solving skills and attention to detail.
- Strong leadership qualities with excellent team management and interpersonal skills.
- Exceptional organizational, planning, and prioritization abilities to manage multiple complex projects simultaneously.
- Adaptable, self-motivated, and able to thrive in fast-paced, evolving environments.
- Excellent verbal and written communication skills with the ability to influence stakeholders at all levels.
- High ethical standards with a focus on compliance, integrity, and patient safety.
- Collaborative mindset with experience integrating and working with remote and cross-cultural teams (e.g., US and APAC).
Travel Required: Up to 20%
Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $186,000-$220,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.
At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.
