Director, Clinical Development – Clinical Science

🕒 vor 27 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $230.000 - $260.000 / Jahr

⏰ Vollzeit

🔴 Experte

👔 Direktor

🗣️🇺🇸🇬🇧 Englisch erforderlich

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Logo of Apogee Therapeutics

Apogee Therapeutics

51 - 200 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

💰 €149.000.000 Series B im 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics ist ein biopharmazeutisches Unternehmen im klinischen Stadium, das sich auf die Entwicklung neuartiger Biologika zur Behandlung von Entzündungs- und Immunerkrankungen konzentriert. Das Unternehmen zielt auf bedeutende Märkte in den Bereichen entzündliche und immunologische Erkrankungen ab, wie z. B. atopische Dermatitis, Asthma, chronisch obstruktive Lungenerkrankung, eosinophile Ösophagitis und andere verwandte Zustände. Apogee Therapeutics strebt an, den aktuellen Behandlungsstandard zu verändern, indem es Antikörpertherapeutika vorantreibt, die auf etablierte biologische Mechanismen abzielen und das Potenzial haben, dermatologische, respiratorische und gastroenterologische Probleme zu adressieren. Das Unternehmen ist dazu verpflichtet, ein psychologisch sicheres Arbeitsumfeld zu schaffen, während es innovative Behandlungsoptionen für Menschen mit diesen Erkrankungen priorisiert.

Beschreibung

• 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

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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

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