Associate Director, Monitoring Oversight Management

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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

• Manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities for Apogee sponsored clinical trials • Support contract Oversight CRAs globally • Serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs • Contribute to building a culture of team, site and patient centricity • Help Apogee become “Sponsor of Choice” with both our CRO partners and sites • Contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies • Ensure study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements • Responsible for hiring in-house Oversight CRAs • Assist with creation, review and revision of departmental SOPs and policies, as applicable • Lead, conduct, and document regular meetings with Oversight CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency • Assist with creation and delivery of department initiatives, improvement plans and/or training • Create SOPs and process to support the responsibilities of the monitoring excellence organization • Responsible for the training and development of in-house Oversight CRAs and ensuring training compliance is maintained • Contribute to development and implementation of risk-based monitoring strategies • Assist monitoring head with resourcing/capacity management projections across clinical studies and/or therapeutic areas • Contribute to overall operational readiness to support clinical operations monitoring oversight activities across studies and/or therapeutic areas • Facilitate resolution of region specific and site management related challenges • Communication and issue resolution with clinical vendors, as needed • Create and implement monitoring processes, tools, and documents (e.g., monitoring oversight plan, site visit report templates, monitoring tools) • Responsible for ensuring Oversight CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections • Responsible for compiling and providing clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities • Support and liaise with clinical site personnel, as needed • Review and approve time sheets and expense reports • Conduct periodic quality visits for Senior Oversight CRAs, as needed • Ensure all site oversight visits are completed within the expected timelines globally • Oversee all timelines and KPIs for the oversight monitoring team globally • Ensure the oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites

🎯 Anforderungen

• Bachelor's degree in a scientific or healthcare-related field • Minimum of 8-10 years of experience as a CRA or related role within the pharmaceutical or biotechnology industry • Minimum 5 years of experience leading a team of CRAs • Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials preferred • Experience working in Phase I – III clinical trials • Recent experience working on trials utilizing risk-based monitoring models • Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet • Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems • Strong understanding of clinical trial processes and study conduct • Excellent organizational and time management skills • Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment and can also work independently without significant oversight • Experience working in a fast-paced and dynamic environment • Certification as a Clinical Research Associate (CCRA) or equivalent preferred • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless • Position requires up to 35% travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year, and a clinical operations meeting held once per year, travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office

🏖️ 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