[Remote] Associate Director, Clinical Operations Standards and Planning

Note: The job is a remote job and is open to candidates in USA. Apogee Therapeutics is a clinical-stage biotechnology company founded in 2022, focused on advancing novel biologics for inflammatory and immunological markets. They are seeking an Associate Director, Clinical Operations Standards and Planning to enhance operational efficiency and maintain clinical operations standards for global clinical trials.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 organizationSkillsMinimum 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 optimization mindset and ability to build structure in dynamic, high-growth environmentsStrong project management skills, effective matrix leadership, and the ability to deliverStrong analytical and forecasting capabilities with demonstrated experience in capacity modeling, utilization optimization, and data-driven decision-makingAbility and thrive in a fast paced, dynamic environmentSuccessfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and EgolessPosition requires up to 30% travelBenefitsMarket competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefitsWe provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leaveCommitment to growing you professionally and providing access to resources to further your developmentApogee offers regular all team, in-person meetings to build relationships and problem solveCompany OverviewApogee Therapeutics is a biotechnology company that offers therapies for immunological and inflammatory disorders. It was founded in 2022, and is headquartered in San Francisco, California, USA, with a workforce of 201-500 employees. Its website is https://apogeetherapeutics.com/.