Associate Director, Clinical Operations Standards – Planning

Role Overview

• 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

Tech Stack

• Google Cloud Platform

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