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Associate Director, Biomarker Development

3 weeks ago
United States
Full-time
Lead
Program Manager
Data Science and Analytics
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 20

Description

  • Lead the development, prioritization, and execution of biomarker strategies for clinical programs in inflammatory and immune indications.
  • Work across Translational Research and Clinical Biomarkers teams to support clinical development efforts.
  • Communicate biomarker plans, rationale, concepts, and findings to internal stakeholders in tailored formats for different audiences.
  • Partner with clinical operations, biomarker operations, and clinical development leads to support study setup and progression into the clinic.
  • Provide input on specimen handling, collection, shipping, storage guidelines, sample testing timelines, and data transfers.
  • Lead development and implementation of assays using flow cytometry, immunoassays, proteomics, and genomics-based tools for clinical trials.
  • Collaborate with biomarker lab and operations teams to optimize assays and troubleshoot performance issues.
  • Assess method feasibility and supervise assay transfer to CROs or academic laboratories.
  • Monitor assay development, qualification/validation, and biomarker testing to ensure high-quality biomarker data.
  • Analyze and interpret biomarker data across platforms with biostatistics and computational biology partners, and use findings to guide program decisions.
  • Contribute biomarker content to INDs, BLAs, clinical protocols, clinical study reports, and other regulatory and study documents.
  • Author and present biomarker data through press releases, posters, publications, and other scientific communications.
  • Collaborate with Research and Computational Science teams to support reverse translation, hypothesis generation, and new target identification.

Requirements

  • PhD with more than 8 years of pharmaceutical or biotechnology industry experience.
  • More than 4 years of experience in a translational role.
  • Experience in the inflammation and immunology therapeutic area.
  • Extensive experience in clinical biomarker strategy and execution.
  • Deep understanding of drug development stages and the role biomarkers play across them.
  • Experience with flow cytometry-based assays, genomics, and protein-based LBA tools.
  • Strong communication and partnership skills in a highly matrixed, cross-functional environment.
  • Strong problem-solving, project management, and time management skills.
  • Ability to manage multiple competing priorities under tight timelines in a fast-paced environment.
  • Willingness to travel up to 10%, including mandatory attendance at All Hands meetings and occasional workshops or conferences.

Benefits

  • Base salary of $190,000-$210,000 per year, depending on experience, education, and geography.
  • Market-competitive compensation package with performance bonus and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Professional development support and access to growth resources.
  • Regular all-team in-person meetings to build relationships and solve problems.

Interested in this position?

Apply directly on the company website

Apply Now

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