Associate Director, Clinical Operations Standards – Planning

🕒 April 6

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Apogee Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

Biotechnology • Pharmaceuticals

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.

📋 Description

• Identify operational efficiencies for Apogee in partnership with key CROs and vendors and implement solutions to support delivery of Clinical Trial Operations team • Partner with key stakeholders including Clinical Trial Operations, Vendor and Strategic Management to ensure vendor performance aligned with Apogee expectation • Proactively identify and maintain standards to ensure consistency across all programs and studies for operationalizing global clinical trials working with assigned CROs • Collaborate with Apogee Process Excellence and QA organizations to ensure that study level operations can be standardized in line with vendor processes to ensure operational efficiency and inspection readiness • Oversee Clinical Operations Resource Planning and Management to ensure efficient utilization of resources across the organization • Support the Clinical Operations Leadership Team (COLT) in establishing and maintaining a defined career ladder to support employee growth and scalability of an expanding organization • Develop, coordinate and maintain operational best practices for key activities for Clinical Operations to support being sponsor of choice for clinical trial sites globally • Collaborate with cross functional Clinical Study Team members to develop end-to-end clinical operations process, tools and resources • Collaborate with Clinical Study Team members and CRO to develop necessary standard practices to meet clinical trial country specific operational requirements • Lead and participate in key process improvement initiatives to ensure continuous process improvement • Lead any assigned departmental activities to support a highly functioning Clin Ops organization

🎯 Requirements

• Minimum 12+ years of pharmaceutical/biotech industry experience in Clinical Operations related role • Bachelor’s degree required • Experience in operationalizing large, global clinical trials and providing oversight of CRO’s and other vendors • Experience driving innovation in clinical trial operations to increase efficiency and implement best practices • Deep understanding of the clinical trial landscape and commitment to efficiency, innovation, and operational excellence • Experience managing CROs, vendors and/or clinical trial consultants • Extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, and major Health Authority regulations • Strong project management skills, effective matrix leadership, and the ability to deliver • Strong analytical and forecasting capabilities with demonstrated experience in capacity modeling, utilization optimization, and data-driven decision-making • Ability to thrive in a fast-paced, dynamic environment • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless • Position requires up to 30% travel

🏖️ 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 • 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