Senior Clinical Trial Manager, Clinical Operations

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 Senior Clinical Trial Manager, Clinical Operations will report to the Director, 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 to collaborate 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:

• 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 recommendation 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 Director, 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
• 7+ years of Clinical Operations experience in the biotech/pharma industries preferred
• Rare disease/orphan drug 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: *

170-185K - *Please note that for remote positions, salary may be adjusted for cost of living

Benefits Offered:

• No premium cost for employees - 100% subsidized by ReCode for full-time employees
• Company 401k contribution
• 15 days of company paid holidays, including a holiday shutdown (usually the last week of the year)
• Mental health support for employees & their families
• FSA available, including a lifestyle spending account subsidized by company
• Employee discounts at hotspots

ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.

ReCode Therapeutics is an Equal Opportunity Employer.