Senior Clinical Operations Consultant, Cystic Fibrosis Program (Contract) - ReCode Therapeutics

Summary of Position: 

The Senior Clinical Operations Consultant (CF Program) will report to the Head of Clinical Operations and will be 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 should have substantial experience in either rare diseases or genetic medicines such as mRNA, gene therapy or gene editing. 

This is a contract position that can be remote but the preferred location is on the west coast (PST time zone).

Responsibilities: 

• Independently/proactively manage all aspects of one or more clinical studies within a 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. IND, pre-IND, orphan applications, etc.) 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  
• 9+ years of Clinical Operations experience in the biotech/pharma industries 
• Rare disease/orphan drug experience a must, Cystic Fibrosis (CF) experience a plus
• Proven track record as Clinical Operations Program Lead  
• Clinical Operations experience across all phases of development from Phase 1-3 with emphasis on early phase development   
• 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  
• Strong organizational skills and able to prioritize and manage multiple ongoing projects simultaneously 
• Excellent oral and written communication skills 
• Champion for change within a fast growing company/department  
• Highly motivated and self starter with an ability to build strong relationships (internal/external) 

Salary Range: *$100-$110/hr

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