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Clinical Operations Study Lead (Contract)

Employer
ReCode Therapeutics
Location
Menlo Park, California
Start date
Feb 27, 2024

View more

Discipline
Clinical, Clinical Research, Manufacturing & Production
Required Education
Bachelors Degree
Position Type
Contract
Hotbed
Biotech Bay

Job Details

Who We Are:

ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and cells implicated in disease, enabling improved efficacy and potency. ReCode’s lead programs include RCT1100 for the treatment of primary ciliary dyskinesia caused by pathogenic mutations in the DNAI1 gene, and RCT2100 for the treatment of the 10-13% of cystic fibrosis patients who have Class I mutations in the CFTR gene and do not respond to currently approved CFTR modulators. RCT1100 and RCT2100 are inhaled disease-modifying mRNA-based therapies formulated using the SORT LNP delivery platform. ReCode is expanding its pipeline to develop potential therapies for other rare and common genetic diseases, including musculoskeletal, central nervous system, liver and infectious disease indications.

Summary of Position: 

The Clinical Operations Study Lead 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. 

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
  • 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 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: *$90-$100/hr

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

Benefits Offered for Full-Time Employees: 

  • 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.

Company

The Why Behind Our Work

We imagine a world where people living with genetic diseases can fully benefit from the promise of genetic medicines. Our novel mRNA and gene correction therapeutics have the potential to make this a reality.

Therapeutic Areas of Focus

Cystic fibrosis

Primary ciliary dyskinesia

Certain cancers and central nervous system (CNS) diseases

Power the Next Wave of Genetic Medicine

We are one of the rare companies whose innovations are poised to fundamentally shift an entire class of medicine.

Join us as we advance our pipeline into clinical development and scale ReCode’s next-generation genetic medicines delivery platform and pipeline.

Company info
Website
Phone
408-585-1700
Location
1140 O'Brien Drive
Menlo Park, CA 94025
US

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