Associate Director, Clinical Development – Immunology

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Apogee Therapeutics

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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

• 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

🎯 Anforderungen

• 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

🏖️ 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