Director, Clinical Biomarkers

Entrada Therapeutics•Boston, MA

2d•$212,000 - $258,000•Hybrid

About The Position

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- 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. You are excited about the opportunity to lead clinical biomarker development and strategy at Entrada. You 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. 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.

Requirements

Ph.D. with 8 + years of relevant experience or Master's in a scientific discipline with 10+ years relevant experience.
Extensive experience in defining and executing “fit-for-purpose” clinical biomarker assays that address key scientific and clinical questions.
Demonstrated expertise with FDA and EMA requirements for biomarker regulatory sections and biomarker related endpoints.
Extensive understanding in developing and optimizing ligand binding assay technologies (e.g. ELISA, MSD) and molecular assays (e.g. qPCR, ddPCR, western blot) and related software for data analysis.
Experience in outsourcing and managing activities at CROs (e.g. managing timelines and technical troubleshooting) and overseeing development and validation of clinical biomarker assays in a GLP and GCP(GXP) environment.
Deep experience and broad technical knowledge related to analyzing complex data.
Strong verbal and written communication and presentation skills.
Strong interpersonal skills and knowledge of intercultural differences; adept at working across multiple functions to drive decision making.
Experience working in a fast-paced, cross-functional environment with multiple competing priorities.

Responsibilities

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 oversee fit-for-purpose assay validation at selected vendors.
Lead biomarker-related sections of clinical study protocols and health authority. submission document 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, workshops, focus groups, and literature/publications to guide best practices for biomarker development and clinical implementation.