In this role, you will work across functions in Translational Research and Clinical Biomarkers to design, prioritize and execute biomarker strategies for clinical programs in I&I indications.
Distil and communicate biomarker plans, rationale, concepts and findings to internal stakeholders at appropriate levels for different audiences. Ability to execute in a highly matrixed model where strong communication and partnership skills are critical to success.
Lead the development and implementation of assays using flow cytometry, immunoassays, proteomics, and genomics-based tools for inclusion in clinical trials. Partner closely with Biomarker Operations and Biomarker Laboratory members to drive optimization and execution of assays.
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 relations 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. With>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 role for biomarkers.
Adaptable approach with good 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 to proactively drive projects and manage timelines and present to a variety of stakeholders and tailor message accordingly.
Familiar with flow-cytometry based assays, genomics and protein (LBA) tools to lead biomarker discovery and development.
Enjoys a fast-pac
Additional Information
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, Apogee'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 (APG777), the company's most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care.
We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: C aring, O riginal, R esilient and E goless and a commitment to refusing to stop at "good enough".
If this sounds like you, keep reading!
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 the Apogee development pipeline.
Apogeetherapeutics · Worldwide