215 First Street
Job Category: Clinical: Clinical Operations and Development
Job Number: 2173
This newly created position reports into the Sr. Director Clinical Development Operations and will assist in shaping the Compliance and Operational Excellence Team. The individual will provide the leadership, subject matter expertise, and strategy to drive clinical development inspection readiness activities, planning, and coordination.
This role will collaborate cross-functionally to drive best practices, create tools, implement lessons learned, and improve future capabilities that overall, enhance the effectiveness of compliant clinical trial execution and “ Real Time” Inspection Readiness.
- Responsible for partnering with heads of various Clinical Development areas and team members to implement a strategic and cohesive approach to Inspection Readiness, overall culture, and quality deliverables
- Collaborates with Clinical Quality Assurance in the preparation and support of Regulatory Authority GCP inspections
- Advise senior management of critical inspection risks, quality and compliance related issues, and corrective actions steps to mitigate inspection risks
- Acts as the subject matter expert and primary point of contact for relevant functional areas on Inspection Support/Inquiries to provide real-time, proactive advice and guidance
- Develops an inspection preparation plan for programs/trials and provides oversight and tracking of all activities.
- Ensure storyboards are being developed for key processes and activities.
- Assist with Site and CRO inspection preparation activities
- Responsible for ongoing identification of opportunities to further develop and improve GCP Inspection Management strategy, processes, tools and templates.
- Assist with optimizing the Standard Operating Procedures (SOPs), processes, training, and rollout across Clinical Development
REQUIREMENTS / QUALIFICATIONS:
- Must enjoy working in a fast-paced, innovative environment. Must be flexible, proactive, efficient, and team player. This is a highly visible, critical position which will require a self-starter with strong leadership, analytical and interpersonal skills. Working knowledge of Clinical Development Activities and ICH-GCP guidelines.
- Bachelor’ s Degree is required. An advanced degree is highly preferred.
- 7+ years of experience gained with a CRO, biotech, or pharmaceutical company
- 5+ years of compliance, GCP Function, or clinical project leadership
- Experience in supporting Regulatory Authority (e.g. FDA, EMA, MHRA) GCP inspections
- Ability to work, lead, coordinate, and project manage activities to drive change within the organization
- Knowledge and preferably experience in global clinical trial execution, drug development process, and operations
- Working knowledge of clinical trial management activities in an outsourced CRO model
- Experience with supporting clinical site and/or vendor audits, development of CAPAs and monitoring their implementation to successful resolution
- Strong strategic, critical thinking skills with ability to influence senior leadership
- Excellent communication skills, verbal, written and presenting in English as well as diplomacy, cross-cultural and team skills
- Ability to management multiple projects simultaneously, prioritize workload for teams and function in fast-paced environment
- Mindset of continuous improvement
- Candidates must be authorized to work in the U.S.