Associate Director - Monitoring Oversight Management

March 26

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Apogee Therapeutics

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Apogee Therapeutics is a clinical stage biotechnology company focused on developing novel biologics for the treatment of inflammatory and immunology disorders. The company targets major markets in inflammatory and immune diseases such as atopic dermatitis, asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, and other related conditions. Apogee Therapeutics seeks to reshape the current standard of care by advancing antibody therapeutics that target well-established biological mechanisms, with the potential to address dermatological, respiratory, and gastroenterological issues. The company is committed to creating a psychologically safe workplace while prioritizing innovative treatment options for those living with these conditions.

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

📋 Description

• We are seeking an Associator Director, Monitoring Oversight Management to manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities for Apogee sponsored clinical trials. • This role will also support contract Oversight CRAs globally. • In this role, you will serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs and contribute to building a culture of team, site and patient centricity. • Helping Apogee become “Sponsor of Choice” with both our CRO partners and sites will be critical. • This role will also contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies.

🎯 Requirements

• 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 to company meetings at least twice per year

🏖️ Benefits

• 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 • Flexible PTO • Two, one-week company-wide shutdowns each year • 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