Director, Clinical Development – Clinical Science

🕒 Maio 15

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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

• Collaborate with cross-functional teams to develop clinical documents for trials with scientific rigor, such as protocol, investigator brochure, clinical study report, scientific publications/presentations, etc. • Contribute scientific input and implementation into the study design and execution, including but not limited to selection of appropriate endpoints, patient populations, and study methodologies; site selection; investigator meetings; and study initiation activities • Monitor the clinical trials for both quality and safety, ensuring adherence to protocols, timelines, and quality standards • Analyze clinical trial data, interpret results, and provide scientific insights to guide decision-making • Collaborate with data management and biostatistics to develop and validate data collection tools and ensure accurate and timely data capture • Foster relationships with clinical investigators to gather insights, address scientific questions, and promote collaboration • Stay current with scientific literature and advancements in immunology related to Apogee’s pipeline • Collaborate with clinical operations, medical affairs, regulatory affairs, biostatistics, and other teams to ensure alignment of clinical strategies with overall program goals

🎯 Requisitos

• Advanced degree in life science field (e.g., PhD, PharmD, or DVM) • Must have 5 +years of experience in research, with 2+ years’ experience working in clinical development within the biotechnology or pharmaceutical industry preferred; focus on immunology and/or dermatology preferred • Strong understanding of clinical trial design, execution, and data analysis • Analytical mindset and ability to interpret complex scientific data • Ability to manage multiple competing priorities with good planning, time management and prioritization skills • Strong communication, technical writing, and presentation skills, with the ability to effectively convey scientific concepts to diverse audiences • Proven ability to work in a cross-functional team environment • Solid knowledge of Good Clinical Practice (GCP) and ethical guidelines governing clinical research • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless • Position requires approximately 35% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical 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