Note: The job is a remote job and is open to candidates in USA. Clarity Pharmaceuticals is a leading radiopharmaceutical company developing Targeted Copper Theranostics for the treatment of serious diseases. The Director, Clinical Quality will provide strategic and operational leadership for the Clinical Quality function, ensuring compliance with GCP and supporting efficient clinical development across the organization.
Responsibilities
- Provide strategic and operational leadership for the Clinical Quality function, ensuring compliance with GCP, applicable global regulations, and company quality standards across clinical development programs
- Build, own, and evolve the Clinical Quality strategy, including quality systems, inspection readiness, audit programs, vendor oversight, and quality risk management
- Lead inspection readiness activities supporting regulatory submissions, including BIMO, pre-approval, and other global health authority inspections, as well as CRO-supported readiness programs
- Serve as a decisive quality authority, ensuring timely escalation, resolution, and communication of quality issues across clinical programs and CRO partnerships
- Oversee timely execution of the risk-based Clinical GxP audit program, including CRO/vendor audits, investigator site audits, internal audits, and mock inspections; serve as Sponsor reviewer/approver of audit processes and reports as needed
- Support CRO, vendor, and investigator site quality oversight programs, ensuring robust performance management and risk-based governance across outsourced clinical operations
- Analyze clinical quality metrics, audit outcomes, and compliance trends to identify systemic risks and drive continuous improvement across programs
- Operate within and continuously improve the Quality Management System, ensuring clinical quality processes and documentation are effective, compliant, and scalable to support development and regulatory submissions
- Partner cross-functionally with Clinical Development, Clinical Operations, and Medical Affairs to develop pragmatic, risk-based quality solutions that enable clinical execution while maintaining compliance
- Provide clinical quality input on essential documents (e.g., study protocols, pharmacy manuals, ICFs) to support timely and strategic program execution
- Represent Clinical Quality in executive forums, governance discussions, regulatory interactions, and due diligence activities
- Build and develop the Clinical Quality team, provide guidance, mentorship, and development, and develop capability to support pipeline growth and business continuity
Skills
- Bachelor's degree in chemistry, Pharmacy, Engineering, Life Sciences, or a related scientific discipline
- At least 10 years of progressive experience in Clinical Quality Assurance or Clinical Quality Management supporting GCP-regulated clinical development in biotech, pharmaceutical, or clinical-site environments
- Demonstrated experience serving as Clinical Quality lead during FDA and/or global regulatory inspections
- Demonstrated experience leading inspection readiness activities, including preparation for FDA, BIMO, and global health authority inspections
- Experience leading CRO-heavy clinical development programs across Phase I–III studies
- Proven experience leading GCP audit programs, including CRO/vendor, investigator site, internal audits, and mock inspections
- Demonstrated experience leading Clinical Quality strategy, quality systems, and risk-based oversight in a fast-paced or resource-limited environment
- Experience overseeing vendor qualifications and oversight programs, including CROs, laboratories, and imaging vendors
- Strong knowledge of ICH-GCP and applicable FDA clinical trial regulations (IND requirements, informed consent, IRB oversight, electronic records), with the ability to operate within other international frameworks
- Demonstrated ability to make independent, risk-based quality decisions and resolve complex clinical quality issues in real time
- Strong ability to communicate and influence across cross-functional teams and senior stakeholders through clear, structured communication
- Experience leading multiple end-to-end regulatory inspections
- Radiopharmaceutical, imaging, or sterile-product clinical development experience
- Prior clinical-site experience (clinical research coordinator, associate, manager, or monitor)
- Experience building or developing a Clinical Quality function in a lean, high-growth organization
- Experience configuring, implementing, and maintaining an eQMS and eTMF
- Advanced degree in life sciences or related scientific discipline
Company Overview