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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical operationsproject managementcapacity modelingutilization optimizationdata-driven decision-makingoperational efficienciesbest practicesvendor managementclinical trial operationsdrug development processes

Soft Skills

leadershipanalytical skillscollaborationinnovationcommunicationproblem-solvingadaptabilityteamworkorganizational skillsinterpersonal skills

Certifications

Bachelor's degree