The Perfect Addition to Our Team

You are a versatile, self-motivated team player who looks forward to rolling up your sleeves. You work collaboratively with different teams and CROs to support preclinical and clinical biomarker development activities. You enjoy a fast-paced environment and are capable of juggling competing priorities. You follow up and follow through, connecting problems with solutions efficiently. You have strong interpersonal skills that allow you to effectively build working relationships inside and outside of the company.

The Opportunity

As a Biomarker development leader, you will join the Biomarkers Team to spearhead and support projects through early to late clinical development. You will work cross-functional and serve as a bridge to discovery, translational, and clinical development teams. You will focus on projects from the start of assay development to clinical trial implementation as well as data management to ensure we are obtaining high-quality data from our clinical trials.

Responsibilities

• Work closely with the preclinical group to define translational hypotheses, including potential pharmacodynamic and predictive biomarkers.
• Design and implement bioanalytical clinical biomarkers and exploratory translational strategies; adhere to clinical and regulatory submission protocols.
• Conduct experiments to design and troubleshoot clinical assay design or ideas in the lab or manage direct report/CRO to find answers.
• Successfully manage CROs and establish relationships to develop biomarker assays, monitor assay qualification/validation at CROs, as well as bioanalytical/biomarker testing in the clinical trials.
• Collaborate with clinical operations and the central lab to develop appropriate clinical laboratory manuals and to support sample management and logistics.
• Perform integrative analysis of multiple biomarker assessments including gene expression, IHC/Multiplex IF data, safety biomarker, and drug response data for baseline and post-dose biomarker discovery for clinical programs.
• Contribute to quality and timely submission of all clinical biomarker-related documents and materials for regulatory filings, including scientific advice filings, INDs, meeting briefing books, and other requests from global regulatory authorities.

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. in biological sciences and 5 or more years of industry (biotech/pharmaceutical) clinical biomarker experience, or MS with 7 years, or BS with 10 years of experience.
• Deep understanding of the pre-clinical, translational, and clinical stages of drug development.
• Extensive working knowledge of biomarker and bioanalytical assay development and cutting-edge Omics methodologies in the clinic.
• Experience leading within and collaborating effectively as a member of a cross-functional team.
• Demonstrable knowledge of appropriate quality standards including ICH/GCP, guidance, and global regulations.
• Experience in selection and management of external CROs.
• Excellent analytical skills, with an ability to communicate complex issues in a simple way.