Associate Director, Clinical Operations Standards and Planning

About Apogee TherapeuticsFounded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.If this sounds like you, keep reading!Role SummaryWe are seeking an Associate Director, Clinical Operations Standards and Planning to join our Clinical Operations Team. This position will be responsible for the identification, documentation, maintenance and optimization of Apogee Clinical Operations standards and best practices to support a growing portfolio of global clinical trials. This position will lead the Clinical Operations organization to identify innovative strategies to increase operational efficiency across programs. Additionally, this role will provide oversight of the Clinical Operations resource planning process to support the Clinical Operations Leadership Team in ensuring appropriate resources are available at the right time to support the Apogee portfolio. This role will report into the Executive Director Process and Strategic Planning and will be a key leader within the Clinical Trial Excellence Team.Key ResponsibilitiesIdentify operational efficiencies for Apogee in partnership with key CROs and vendors and implement solutions to support delivery of Clinical Trial Operations teamPartner with key stakeholders including Clinical Trial Operations, Vendor and Strategic Management to ensure vendor performance aligned with Apogee expectationProactively identify and maintain standards to ensure consistency across all programs and studies for operationalizing global clinical trials working with assigned CRO’sCollaborate 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 readinessOversee Clinical Operations Resource Planning and Management to ensure efficient utilization of resources across the organizationSupport the Clinical Operations Leadership Team (COLT) in establishing and maintaining a defined career ladder to support employee growth and scalability of an expanding organizationDevelop, coordinate and maintain operational best practices for key activities for Clinical Operations to support being sponsor of choice for clinical trial sites globallyCollaborate with cross functional Clinical Study Team members to develop end-to-end clinical operations process, tools and resourcesCollaborate with Clinical Study Team members and CRO to develop necessary standard practices to meet clinical trial country specific operational requirementsLead and participate in key process improvement initiatives to ensure continuous process improvementLead any assigned departmental activities to support a highly functioning Clin Ops organizationIdeal CandidateMinimum 12+ years of pharmaceutical/biotech industry experience in Clinical Operations related roleBachelor’s degree requiredExperience in operationalizing large, global clinical trials and providing oversight of CRO’s and other vendorsExperience driving innovation in clinical trial operations to increase efficiency and implement best practicesDeep understanding of the clinical trial landscape and commitment to efficiency, innovation, and operational excellenceExperience managing CROs, vendors and/or clinical trial consultantsStrong leadership, communication, and interpersonal skills, with the ability to influence and align diverse groups across functions at all levels of the organizationExtensive knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, an major Health Authority regulationsSystems thinker with process