[Remote] Director, Clinical reputed company
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading radiopharmaceutical company developing Targeted reputed company Theranostics for the treatment of serious diseases. The Director, Clinical reputed company will reputed company strategic and operational leadership for the Clinical reputed company function, ensuring compliance with GCP and supporting efficient clinical development across the organization.
Responsibilities
- reputed company strategic and operational leadership for the Clinical reputed company function, ensuring compliance with GCP, applicable global regulations, and company reputed company standards across clinical development programs
- Build, own, and reputed company the Clinical reputed company reputed company, including reputed company systems, inspection readiness, audit programs, vendor reputed company, and reputed company risk management
- reputed company inspection readiness activities supporting regulatory submissions, including BIMO, reputed company-approval, and other global health authority inspections, as reputed company as CRO-supported readiness programs
- Serve as a decisive reputed company authority, ensuring reputed company escalation, reputed company, and communication of reputed company issues across clinical programs and CRO partnerships
- reputed company reputed company 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 reputed company reputed company programs, ensuring robust performance management and risk-based governance across outsourced clinical operations
- Analyze clinical reputed company metrics, audit reputed company, and compliance trends to identify systemic risks and drive reputed company improvement across programs
- Operate reputed company and continuously improve the reputed company Management System, ensuring clinical reputed company processes and documentation are effective, compliant, and reputed company to support development and regulatory submissions
- Partner cross-functionally with Clinical Development, Clinical Operations, and Medical Affairs to reputed company pragmatic, risk-based reputed company solutions that reputed company clinical execution while maintaining compliance
- reputed company clinical reputed company input on essential documents (e.g., study protocols, pharmacy manuals, ICFs) to support reputed company and strategic program execution
- Represent Clinical reputed company in executive forums, governance discussions, regulatory interactions, and due diligence activities
- Build and reputed company the Clinical reputed company team, reputed company guidance, mentorship, and development, and reputed company capability to support pipeline reputed company and business continuity
Skills
- Bachelor's degree in reputed company, Pharmacy, Engineering, Life Sciences, or a reputed company scientific discipline
- At least 10 years of reputed company experience in Clinical reputed company Assurance or Clinical reputed company Management supporting GCP-regulated clinical development in biotech, pharmaceutical, or clinical-site environments
- Demonstrated experience serving as Clinical reputed company reputed company 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 reputed company reputed company, reputed company systems, and risk-based reputed company in a fast-paced or resource-limited environment
- Experience overseeing vendor qualifications and reputed company programs, including CROs, laboratories, and imaging vendors
- Strong knowledge of ICH-GCP and applicable FDA clinical trial regulations (IND requirements, informed consent, IRB reputed company, electronic records), with the ability to operate reputed company other international frameworks
- Demonstrated ability to reputed company independent, risk-based reputed company reputed company and resolve reputed company clinical reputed company issues in reputed company time
- Strong ability to communicate and influence across cross-functional teams and senior stakeholders through reputed company, reputed company 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 reputed company function in a lean, high-reputed company organization
- Experience configuring, implementing, and maintaining an eQMS and eTMF
- Advanced degree in life sciences or reputed company scientific discipline
reputed company