Senior Clinical Trial Manager Consultant

3 weeks ago

Menlo Park, United States BioSpace, Inc. Full time
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:

We are seeking an experienced and dynamic Senior Clinical Trial Manager Consultant ReCode's RCT2100 CF program. You are a self-motivated leader that implements global clinical operations strategy for ReCode's programs. You will be responsible for collaborating with Clinical Operations and 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 clinical trial startup/conduct including CROs, vendors, and key stakeholders.
  • Accountable for clinical operations startup timelines and working closely with CF Clinical Operations Program Lead to keep internal/external teams on track.
  • 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 CF Clinical Operations Program Lead and Head of Clinical Operations.
  • Navigate team structure (Study execution meeting and clinical meetings) and decision makers to independently resolve issues and escalate challenges/obstacles effectively.
  • Participate in supporting program team on key regulatory filings (e.g. US IND, UK MHRA, EU CTIS, etc) as needed.
  • Experience managing/collaborating with CROs and other study vendors.
  • Support Study Execution Team meetings.
Qualifications:
  • BS/BA required with 7+ years of Clinical Operations experience in biotech/pharma managing Phase 1-3 clinical trials.
  • Rare disease/orphan drug experience preferred.
  • Proven track record as Clinical Trial Manager (Global Study Lead experience preferred) in rare disease clinical trials.
  • Working knowledge of study startup timelines/management and study conduct in European region in ultra rare disease indications.
  • Track record of success in negotiating with CROs and representing the sponsor to internal and external stakeholders (ie site/vendor relationships).
  • Demonstrated knowledge of ICH GCP and thorough knowledge of clinical monitoring procedures.
  • 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.
  • Ability to travel for periodic site initiation visits, and co-monitoring visits.
Salary Range: $75-$90/hr

Location: Remote (East Coast Based)

*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.

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