AD/Director, Clinical Operations

Responsibilities including but not limited to:

• Independently/proactively manage all aspects of multiple clinical studies within a complex program, including the study team and all external vendors.
• Provide oversight and guidance to internal Clinical Operations team.
• Accountable for clinical operations timelines and working closely with Core Team Program Manager to keep internal/external teams on track.
• Maintain expert knowledge of Clinical Development programs. Can independently interpret data and make recommendations on next steps.
• Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.
• Develop and ensure execution of activities outlined in various study plans (sponsor oversight, monitoring, deviation, training, and study communication plans).
• Co-monitor or monitor studies if needed for the program.
• Drive communication and escalate issues to Head of Clinical Operations as appropriate, Clinical Sub Team.
• Navigate team structure (Study execution meeting and clinical meetings) and decision makers to independently resolve issues and escalate challenges/obstacles effectively.
• Participate in preparation of regulatory filings (e.g. US IND, EU CTIS, UK MHRA) as needed.
• Experience managing/collaborating with CROs and other study vendors.
• Support and lead Study Execution Team meetings.
• Lead cross-functional teams, pro-actively shaping team dynamics to support collaboration and accountability.
• Oversee performance, manage, and serve as point of contact for all CROs and vendors.
• Manage vendor scope and budgets in alignment with study (program) budget.
• Manage study resources, internally and externally, to optimize performance to study deliverables.
• Demonstrate ability to mitigate and escalate changes in scope appropriately.
• Create and manage standardized clinical trial tools, processes, and SOPs.
• Be accountable for clinical trial enrollment (ie develop recruitment strategies) and risk mitigations.
• Ability to be accountable for decisions made as Clinical Operations lead, and escalate issues/risks in real time.
• Experience managing/mentoring direct/indirect reports.

Qualifications:

• BS/BA required with Advanced degree desirable
• 10 years of Clinical Operations experience in the biotech/pharma industries
• Proven track record as Clinical Operations Program Lead
• Clinical Operations experience across all phases of development from Phase 1-3
• Track record of success in negotiating with CROs and representing the sponsor to internal and external stakeholders (ie site/vendor relationships)
• Ability to build site relationships with key site staff/PIs globally to move clinical trials forward
• Prior experience leading a program and study team
• Prior experience managing direct reports
• Demonstrated knowledge of ICH GCP
• Regulatory inspection experience a plus
• Strong understanding/experience in rare disease patient recruitment and site/patient engagement strategies
• Highly responsive and proactive team player
• Ability to have growth mindset when problem solving complex issues
• Strong organizational skills and able to prioritize and manage multiple ongoing projects simultaneously
• Excellent communication and interpersonal skills with the ability to collaborate and work effectively in a cross-functional, fast-paced environment.
• Champion for change within a fast-growing company/department
• Positive attitude with an emphasis on team-based problem-solving approach