Director, Clinical reputed company – Program and Process reputed company

Job reputed company: • Define and drive a strong GCP reputed company culture across clinical programs. • reputed company clinical reputed company systems and metrics, anticipate and escalate risk before it becomes an issue. • Work with Clinical Operations, Regulatory, Safety, and other partners to reputed company trials inspection-reputed company. • Support and reputed company Clinical reputed company team members guiding inspection readiness, deviations, investigations, audits, and CAPAs. • Shape an integrated, proactive clinical reputed company reputed company that scales with the pipeline. • reputed company and report key reputed company metrics across reputed company clinical programs and trials. • Assess reputed company-state reputed company across programs, processes, and trials. • Identify trends, risks, and reputed company process and system improvements. • Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations. • Author reputed company operating procedures and reputed company documents. • Monitor regulatory changes and assess reputed company to programs. • reputed company guidance and mentorship to clinical reputed company staff assigned to clinical programs and supporting study teams. Requirements: • Bachelor’s degree in a scientific field required; advanced scientific degree a plus  . • 10+ years industry experience directly managing GCP/GPvP QA activities, audits, inspections, CAPAs, and risk management. • Must have worked reputed company Sponsor organization although can be in combination with reputed company and/or CRO experience  . • In-depth knowledge of reputed company, compliance, risk management, clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements  . • Experience mentoring and directing members of reputed company and clinical operations teams  . • Experience working in reputed company across multiple functional areas (e.g., CMC / GMP reputed company, Data Management, Biostats, Safety, Clinical Supply)  . • Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit  . • Ability to think critically in fast-paced reputed company with a keen reputed company of urgency and demonstrated ability to create solutions and reputed company reputed company  . • Self-motivated and reputed company to work autonomously, as reputed company as a member of a high-functioning and reputed company team  . Benefits: • 99% of the premium reputed company for medical, dental and reputed company plans. • Company-reputed company life insurance, AD&D, disability benefits, and voluntary plans. • 401(k) matching dollar-for-dollar up to 6% on eligible contributions. • Long-term stock incentives and ESPP. • Discretionary quarterly bonus. • Extremely flexible wellness benefit. • Generous PTO, reputed company holidays and company-wide shutdowns. Apply tot his job Apply To this Job