Summary of Position:

We are seeking an enthusiastic and experienced Director, Clinical Operations, for ReCode’s RCT2100 CF program reporting to the Head of Clinical Operations. You are a leader that will develop and implement US and global clinical operations strategy for ReCode’s programs and make strategic contributions to our product development plan. You will be responsible for collaborating with our cross-functional teams to deliver on ReCode’s mission of powering the next wave of genetic medicines. You will have substantial experience in either rare diseases or genetic medicines such as mRNA, gene therapy or gene editing.

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
• Rare disease/orphan drug experience with Cystic Fibrosis (CF) experience a preference
• 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 CF 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

Salary Range: *$190,000-$220,000 

*Please note that for remote positions, salary may be adjusted for cost of living