Director, Clinical Biomarkers

Entrada Therapeutics 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‑and protein‑based programs for the potential treatment of neuromuscular and ocular 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.

You are excited about the opportunity to lead clinical biomarker development and strategy  enjoy a fast‑paced environment and juggling competing priorities. You bring an in‑depth knowledge of biomarker development and strategy, a broad understanding of regulatory expectations supporting assay performance across various stages of clinical development, and you follow up and follow through, efficiently connecting problems with solutions. You work successfully in a team environment, with strong people skills to effectively build working relationships inside and outside of the company.

The Director, Clinical Biomarkers, will lead scientific efforts in developing and executing biomarker strategy to support clinical trials. This position will lead both at external CROs and specialty labs and perform technical and strategic assessments of new and innovative biomarker platforms to support Entrada’s drug development pipeline. Additionally, this role will support and lead the internal biomarker team to provide mentorship and training to team members of various levels of skill and competencies.

The candidate must possess effective project management skills and communicate progress and risks toward the timely delivery of biomarker assays to support clinical programs.

• Lead internal clinical biomarker initiatives in the development, transfer, and execution of stage‑appropriate biomarker assays for clinical development.
• Effectively identify and manage on‑going activities for biomarker testing and technology solutions to support ongoing and planned clinical trials.
• Demonstrate an established depth and/or breadth of expertise in biomarker assays and provide strong technical guidance; managing the assay development/transfer and overseeing fit‑for‑purpose assay validation at selected vendors.
• Lead biomarker‑related sections of clinical study protocols and health authority submission documents and align biomarker strategy cross‑functionally.
• Serve as the subject‑matter expert for biomarker related regulatory filings and health authority queries.
• Operationalize biomarker tests and ensure results are delivered and archived per clinical development needs.
• Collaborate with Program Team Leaders, Regulatory, and Medical Directors in the review of clinical protocols, investigator training documents, lab manuals, clinical sample analysis, and regulatory submission activities for clinical development.
• Partner with Discovery and Product Development teams in the evaluation and development of clinical biomarker assays and vendor selection for early projects.
• Manage, identify, and communicate risks to stakeholders in a clear and timely fashion.
• Manage and guide junior level staff for successful assay development and execution within the biomarker function.
• Actively engage with industry professionals via attendance and delivery of presentations in conferences,…