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Director, Clinical Biomarkers

Boston, MA

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- 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.

The Perfect Addition to Our Team

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 Opportunity

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.

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.

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:

  • 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.
  • This role follows a hybrid working model, with in office attendance 2-3 days per week minimum at the Entrada Therapeutics Headquarters in Boston, MA. 

What We Offer: Meaningful Work, Fair Rewards, and Real Support

At Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity. We believe in transparency and equity and are committed to sharing salary ranges for every position, along with insight into our compensation philosophy, in accordance with certain state requirements in the United States and fostering a fair and open environment at the onset.

But we also know it is more than just pay. When you join Entrada, you’ll be part of a mission-driven team with access to comprehensive health, dental and vision coverage; life and disability insurance; with a 401(k) match. We pride ourselves on offering competitive benefits that empower our employees and reflect the value of their contributions – offering paid, gender-inclusive parental leave, holistic support for your health and well-being, education reimbursement, discretionary time off and commuting benefits aligned to your working model. If you find yourself working from our office in Boston’s Seaport District, this puts you steps away from some of the best the city has to offer.

“Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, we know that meaningful work deserves meaningful reward — and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward.”

— Kerry Robert, SVP of People

The salary for this opportunity ranges from $212,000 – $258,000. The final base compensation offered will depend on several considerations which include but may not be limited to a candidate’s skills, competencies, experience and other job-related factors permitted by law. The final salary offered may fall outside of this range.

Equal Opportunity Employer

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law. 

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Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.

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