Associate Director, Biomarker Development

🕒 Maio 29

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Apogee Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

💰 $149.000.000 Series B em 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics é uma empresa de biotecnologia em fase clínica focada no desenvolvimento de novos biológicos para o tratamento de distúrbios inflamatórios e imunológicos. A empresa mira mercados principais em doenças inflamatórias e imunológicas como dermatite atópica, asma, doença pulmonar obstrutiva crônica, esofagite eosinofílica e outras condições relacionadas. A Apogee Therapeutics busca reformular o padrão atual de cuidados ao avançar terapias com anticorpos que visam mecanismos biológicos bem estabelecidos, com potencial para atender questões dermatológicas, respiratórias e gastroenterológicas. A empresa está comprometida em criar um ambiente de trabalho psicologicamente seguro enquanto prioriza opções de tratamento inovadoras para aqueles que vivem com essas condições.

Descrição

• Lead the development of biomarker strategies and execution for clinical development of programs in inflammatory and immune indications. • 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. • 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.

🎯 Requisitos

• 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

🏖️ Benefícios

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve