Role Summary
We 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 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