Vice President, Clinical Operations
Avalyn Pharma
Google Cloud Platform
Senior Director, Clinical Operations
Sumitomo Pharma America, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $222,320 - $277,900 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Ensure monitoring across all studies is conducted in alignment with regulatory requirements
- Define and implement risk-based monitoring strategies
- Maintain expert proficiency in systems and technology for central monitoring analytics
- Contribute to design of novel systems in alignment with department and company data strategy
- Lead or contribute to cross-functional initiatives and process improvement efforts
- Assist with development and maintenance of inspection-readiness processes and materials
- Lead and provide oversight of the Clinical Records Management team
- Develop and/or review budgets for clinical operations and vendor budgets
- Manage direct reports, providing guidance, mentorship, and performance feedback
Requirements
- Bachelor's or advanced degree preferably in life sciences, pharmacy, or related field
- Minimum 15 – 20 years (w/o Master’s) or 10 – 15 years (with Master’s) of relevant experience in biotech or pharmaceutical industry
- Extensive knowledge of clinical development principles, theories and concepts including GCP and ICH-Guidelines
- Advanced proficiency in clinical operations monitoring and oversight
- Visionary in risk-based quality management, analytics, and graphical visualizations
- Experienced in systems/technology implementation and maintenance supporting Clinical Operations, particularly eTMF and Operational Data Modeling systems
- Strong cross-functional communication skills with global partnerships and executive leadership
- Must be tactful, mature, flexible, and possess well-developed interpersonal skills
Benefits
- Health insurance including medical, dental, and vision
- 401(k) plan eligibility
- Merit-based salary increases
- Short incentive plan participation
- Flexible paid time off
- 11 paid holidays
- 80 hours of paid sick time upon hire and each year thereafter
- Additional time off for a shut-down period during the last week of December
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
risk-based monitoring strategiesclinical operations monitoringclinical development principlesGCPICH-Guidelinesanalyticsgraphical visualizationseTMFOperational Data Modeling
Soft skills
cross-functional communicationmentorshipperformance feedbacktactfulnessmaturityflexibilityinterpersonal skills
