Original listing text, shown exactly as published by the company.
Key Responsibilities
- 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 CRO’s
- 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
Ideal Candidate
- 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
- Strong leadership, communication, and interpersonal skills, with the ability to influence and align diverse groups across functions at all levels of the organization
- Extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, an major Health Authority regulations
- Systems thinker with process optimization mindset and ability to build structure in dynamic, high-growth environments
- 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 and 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
The anticipated salary range for candidates for this role will be $175,000 - $195,000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
