Apogee Therapeutics - Remote work

Lead late-stage development and commercialization of monoclonal antibodies as an MSAT Associate Director. This role provides technical oversight for Drug Substance manufacturing at CDMOs, from tech transfer to PPQ. Requires a PhD and 7+ years of biologics experience. Enjoy competitive compensatio...

Join Apogee as an Associate Director of GMP Quality Assurance. Lead QA for biologics and device manufacturing, ensuring compliance with FDA, EMA, and ISO standards. This pivotal role requires 7+ years of biotech/pharma QA experience. Enjoy a dynamic culture, competitive compensation, and equity o...

Lead biostatistics for key clinical projects as an Associate Director. This senior role requires 8+ years' experience, including Phase 3 studies and regulatory submissions. You will provide expert statistical leadership from design through analysis. We offer a competitive compensation package and...

Lead our commercial KOL and patient advocacy strategy in Atopic Dermatitis. This senior role requires 10+ years' industry experience, deep dermatology knowledge, and a proven track record in strategic engagement. You will identify and cultivate relationships with key opinion leaders and advocacy ...

Lead the design and implementation of Apogee's new enterprise Data Lakehouse as a hands-on Director. This individual contributor role requires 10+ years in data engineering, cloud platforms like Databricks, and expertise in data modeling for clinical/life sciences use cases. Own the platform road...

Lead global CMC and device regulatory strategy for innovative drug-device combination products. This senior role requires 10+ years' experience, including biologics CMC and late-stage submissions (BLA/MAA). You will ensure compliance, lead cross-functional teams, and interact with global health a...

Lead clinical development for innovative dermatology therapies, focusing on atopic dermatitis trials. This director-level role requires a PhD/advanced degree and 5+ years of research experience, ideally within biotech/pharma. You will design, oversee, and analyze studies while collaborating cross...

Seeking an experienced Clinical Trial Manager to oversee global Phase I-III studies from planning through execution. You will ensure GCP compliance, manage CRO/vendor partnerships, and drive timelines and data quality for regulatory submission. This role offers a dynamic environment with competit...

Lead our clinical monitoring team as a Clinical Monitoring Manager. Oversee in-house and CRO CRAs for Apogee-sponsored trials, ensuring GCP compliance from site identification to close-out. This US-based role requires 8+ years of CRA experience, including 2 years in team leadership. We offer a co...

Lead a global team of Oversight CRAs for Apogee's clinical trials in this Associate Director role. Utilize your 8-10+ years of CRA experience and 5+ years of leadership to ensure quality monitoring and site management. Develop risk-based strategies and processes while fostering a patient-centric ...