Remix Therapeutics

Remix Therapeutics

Senior Director, Clinical Operations

Watertown, MA · Director

Sponsorship not specifiedDetected 42 days ago
GCPSupply ChainPerformance ManagementClinical TrialsFDA RegulatoryLeadershipBiostatisticsRegulatory Affairs

About the role

  • Remix is seeking a Senior Director, Clinical Operations to lead our clinical operations function at a pivotal moment for REM-422 and the ACC patients we serve.
  • Reporting to the SVP, Clinical Develop ment Operations & Patient Advocacy you will drive operational execution, mentor and develop a team, and work at the intersection of science and execution to bring a potential first-in-class therapy across the finish line.

Responsibilities

  • Lead internal and outsourced teams in end-to-end operational execution of REM-422 clinical studies with responsibility for timelines, budgets, enrollment, and quality in accordance with ICH GCP and applicable regulations.
  • Build and drive comprehensive program plans: study protocols, risk registers, site and country strategy, risk-based monitoring, and vendor approach
  • Lead site selection, activation, and ongoing performance management
  • develop enrollment and retention strategies purpose-built for the ACC patient population.
  • Lead CRO and vendor performance by set expectations, manage contracts and resolve issues before they become delays, and always maintain inspection readiness and TMF integrity.
  • serve as the operational lead for inspection activities and provide guidance to clinical study leads accordingly.
  • Build relationships with investigators primarily in the US and Europe.
  • Partner with Supply Chain Management to coordinate clinical supply planning with CMC and external partners to ensure uninterrupted drug availability across all active sites.
  • Contribute to the development of clinical documents protocols, IND submissions, Investigator Brochures, clinical study reports.
  • Partner with Regulatory Affairs and Biostatistics for submission readiness.

Requirements

  • 12+ years in clinical operations with some small company biotech experience leading Registrational Programs.
  • Experience running complex, multi-site studies from startup through submission readiness and know what it takes in a small-company environment.
  • Demonstrated leadership and people management experience with cross-functional teams.
  • Expert-level CRO oversight and vendor governance.
  • Strong command of GCP, ICH guidelines, and FDA/EMA requirements.
  • Demonstrated experience supporting clinical programs from IND through NDA submission and regulatory approval, including registrational trials.
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Nice to have

  • BS/BA required, advanced degree preferred.
  • Deep oncology or rare disease trial experience strongly preferred.

Company info

  • At Remix Therapeutics, we intend to change that.
  • We are a clinical-stage biopharmaceutical company that has pioneered a new class of small molecule medicines targeting the RNA splicing machinery - correcting the disease-causing errors that drive ACC and other serious conditions at their source.
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