Clinical Trial Manager, Clinical Operations, Cystic Fibrosis Program

Who We Are:

We are a clinical stage company powering the next wave of genetic medicine through superior delivery with our next-generation lipid nanoparticle delivery platform. Our mRNA and gene editing therapeutics have the potential to directly replace or address underlying genetic mutations in a vast range of diseases starting with primary ciliary dyskinesia and cystic fibrosis. Our selective organ targeting (SORT) LNP platform is uniquely differentiated to enable the delivery of diverse genetic payloads to tissues beyond the liver.

At ReCode, we bring a unique blend of rigor, creativity, and curiosity to our high-hurdle mission. Our team is uniquely positioned to tackle this challenge, given our extensive experience in lipid nanoparticle delivery, mRNA design and optimization, mRNA manufacturing, gene editing, and rare disease drug development. We are a high performing, highly functional organization with a culture that is caring and strives to enable every member of our team to thrive.

Summary of Position:

The Clinical Trial Manager, Clinical Operations will report to the Head of Clinical Operations. In this role, you will be a leader that will develop and implement US and global clinical operations strategy for ReCode’s Cystic Fibrosis (CF) program 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.

Responsibilities:

• Independently/proactively manage all aspects of one or more clinical studies within a program, including the study team and all external vendors
• Accountable for clinical operations study timelines and working closely with Clinical Operations Program Lead and 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 Clinical Operations Program Lead
• 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
• Experience in clinical trial site management including developing relationships with KOLs/site coordinators in partnership with Clinical Development Lead
• 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 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 and contribute to process/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 mentoring direct/indirect reports

Qualifications:

• BS/BA required
• 6+ years of Clinical Operations experience in the biotech/pharma industries
• Rare disease/orphan drug experience, Cystic Fibrosis (CF) experience a plus
• Proven track record as Clinical Trial Manager (Study 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)
• Prior experience leading a study team
• 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

 Salary range: