Associate Director, Biomarker Development

Associate Director, Biomarker Development

Remote

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well‑funded, Nasdaq‑listed company that offers the opportunity to work in a fast‑paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics is a clinical‑stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets. The company’s antibody programs are designed to overcome limitations of existing therapies by targeting well‑established mechanisms of action and incorporating advanced antibody engineering to optimize half‑life and other properties. Zumilokibart (APG
777), the most advanced program, is being initially developed for the treatment of atopic dermatitis (AD) and asthma. With four validated targets in its portfolio, Apogee aims to achieve best‑in‑class efficacy and dosing through monotherapies and combinations of its novel antibodies.

We are a fast‑paced company committed to building an exceptional culture, founded on our C.O.R.E. values:
Caring, Original, Resilient and Egoless, and a commitment to refusing to stop at “good enough.”

Role Summary

The Department of Research and Translational Medicine is seeking an Associate Director, Biomarker Development. This person will lead the development of biomarker strategies and execution for clinical development of programs in inflammatory and immune indications across Apogee’s development pipeline.

Key Responsibilities

• Design, prioritize, and execute biomarker strategies for clinical programs in I&I indications.
• Distill and communicate biomarker plans, rationale, concepts and findings to internal stakeholders at appropriate levels for different audiences.
• Work closely with clinical operations, biomarker operations, medical and clinical development leads to drive the program to the clinic, including finalization of lab manuals, specimen handling, collection, shipping and storage guidelines, sample testing timelines and data transfer oversight.
• Lead the development and implementation of assays using flow cytometry, immunoassays, proteomics, and genomics‑based tools for inclusion in clinical trials.
• Collaborate with Research, Biomarker Lab team and Biomarker Operations to assess method feasibility and supervise assay transfer to CROs; design and oversee experiments to troubleshoot assay performance issues.
• Establish relationships with CROs or academic laboratories to execute biomarker strategy, monitor assay development including qualification/validation and biomarker testing in clinical trials to ensure high‑quality biomarker data.
• Analyze and interpret biomarker data generated across multiple platforms, in conjunction with biostats and computational biologists, to provide guidance on program impact and next steps.
• Contribute to biomarker sections of all regulatory documents; including INDs and BLAs, clinical protocols, clinical study reports and other study related documents.
• Author and present biomarker data to internal and external scientific community, including press releases, posters and publications, to articulate the “why” and the “so‑what” behind the biomarker deliverables.
• Collaborate with Research function and Computational Science to facilitate reverse translation of clinical biomarker data for hypothesis generation and new target identification.

Ideal Candidate

• PhD with >8 years of pharmaceutical/biotech industry experience, including >4 years in a translational role.
• Experience in Inflammation & Immunology therapeutic area.
• Extensive experience in clinical biomarker strategy and execution, deep understanding of drug development stages and the role for biomarkers.
• Adaptable with strong problem‑solving skills, able to pivot in response to real‑world problems and data‑driven findings.
• Highly experienced in leading and collaborating effectively as a member of cross‑functional teams, excellent communication skills and ability to proactively drive projects, manage timelines and tailor messages to a variety of…