Original listing text, shown exactly as published by the company.
Key Responsibilities
- 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.
- Work closely with clinical operations, biomarker operations, medical and clinical development leads in driving the program to the clinic including finalization of lab manuals by providing input to specimen handling, collection, shipping and storage guidelines, set up sample testing timelines and oversee data transfers.
- 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-paced environment, flexible, able to manage multiple and competing priorities under tight timelines. Strong project management and time management skills required.
- Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
- Position requires up to 10% travel including mandatory attendance at All Hands meetings typically held twice per year and other workshops or conferences
The anticipated salary range for candidates for this role will be $190,000-$210,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
