Associate Director, Clinical Development – Immunology

🕒 Maio 28

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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

• Monitor clinical trial conduct for quality, safety, protocol compliance, and data integrity • Perform ongoing review and interpretation of emerging clinical trial data, including safety, efficacy, and operational trends • Collaborate cross-functionally to develop and review key clinical documents including protocols, informed consent forms, investigator brochures, clinical study reports, medical monitoring plans, safety narratives, and scientific presentations • Collaborate with Data Management and Biostatistics to support data review, data cleaning activities, database locks, and validation of data collection tools • Partner closely with Clinical Operations and CRO partners to support site management, enrollment and retention strategy, issue escalation, and study execution • Develop strong working relationships with investigators, study coordinators, and key external stakeholders • Stay current on scientific and clinical developments in atopic dermatitis and immunology to support competitive awareness and strategic planning • Support inspection readiness activities and ensure compliance with GCP and applicable regulatory requirements

🎯 Requisitos

• Advanced degree in life sciences (e.g., PhD, PharmD, APNP, DVM, or equivalent clinical/scientific training) • Minimum 5+ years of relevant clinical research experience, including biotechnology or pharmaceutical industry experience in Clinical Development • Prior experience supporting clinical trials in immunology, dermatology, or atopic dermatitis preferred • Strong understanding of clinical trial conduct, safety review, data interpretation, and cross-functional study execution • Ability to analyze and interpret complex clinical data and communicate findings clearly • Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment • Excellent communication, presentation, and technical writing skills • Proven ability to work effectively in cross-functional teams and collaborate with internal and external stakeholders • Working knowledge of GCP and global clinical trial regulations • Demonstrated alignment with Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless • Approximately 25% travel required (may include both US and international travel), including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year, site visits, and medical congresses

🏖️ 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