Senior Director, Clinical Operations

Remix Therapeutics•Watertown, MA

3d•$230,000 - $281,000

About The Position

Patients with adenoid cystic carcinoma (ACC) have waited decades for a treatment option. 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. REM-422 is our lead program and our near-term focus. In addition to ACC REM-422 is currently being evaluated as a treatment for AML/HR-MDS with aspirations to evolve into other oncology indications with high unmet need. REM-422 is at a critical inflection point in its clinical development, and Remix is building the team to bring this novel molecule forward as a medicine for patients. 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 Development 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.

Requirements

BS/BA required, advanced degree preferred.
12+ years in clinical operations with some small company biotech experience leading Registrational Programs.
Deep oncology or rare disease trial experience strongly preferred.
Experience running complex, multi-site studies from startup through submission readiness and know what it takes in a small-company environment.
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.
Demonstrated leadership and people management experience with cross-functional teams.
Operates well in ambiguity; makes sound decisions with incomplete information; moves quickly without cutting corners and brings the team with them.

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; contribute strategic input into Clinical Development Plans.
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.
Represent Clinical Operations on the program team.
Ensure compliance with GCP, ICH guidelines, and Remix SOPs at every stage of trial conduct; 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.
Manage and develop team members and build a culture where accountability and operational excellence are the standard.