Senior Manager, Biosample Operations

The Organization

What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.

Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.

The Perfect Addition to Our Team

You are excited about the opportunity to spearhead and support the expansion of our clinical operations function here at Entrada within Biosample Operations. You are well organized and like to share best practices in clinical operations, clinical supply, and logistics. You enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help wherever it is needed. You follow up and follow through, efficiently connecting problems with solutions. You work successfully in a team environment and have strong interpersonal skills, in order to effectively build working relationships inside and outside of the company.

The Opportunity

The Senior Manager, Biosample Operations, will be responsible for planning, implementing, and managing biological sample logistics across Phase I-IV Clinical Trials. This role is an essential member of the Clinical Operations function and must be able to collaborate with the cross-functional teams both internally and externally to achieve project milestones and clinical study timelines in alignment with company goals.

Responsibilities

• Advise on and deliver the sample strategy for clinical trials within the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP.
• Oversee operational activities required to manage the lifecycle of clinical trial samples, including, but is not limited to, oversight of sample collection at sites, shipment to vendor for processing/testing, managing sample queries, and final sample disposition.
• Implement and execute sample collection, processing, storage, and reconciliation, with the goal of maximizing sample accrual and quality.
• Independently review clinical study protocols, informed consents, laboratory documents, case report forms, laboratory scopes of work, laboratory budgets and invoices.
• Manage necessary vendor laboratory documents for the Trial Master File (TMF) as applicable.
• Act as the primary point of contact for study team related to sample operations for assigned clinical trials.
• Collaborate with cross-functional study teams to ensure delivery of samples per project milestones.
• Track and report on sample management status and address issues proactively.
• Lead innovation and process improvement activities for Biosample Operations and/or Clinical Operations functions.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
• Creativity - We are creative problem solvers.
• Collaboration - We are more than the sum of our parts.
• Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

• Bachelor’s degree, preferably in a scientific or healthcare field or equivalent combined education, with 7+ years of overall clinical operations experience, and 4 + years of experience directly in biosample operations.
• In-depth understanding of clinical trial processes from study start-up through study closure related to sample collection, logistics, transit, storage, central tracking and global requirements.
• Excellent knowledge of ICH GCP and GLP