Apogee Therapeutics - Associate Director, Clinical Operations Standards and Planning
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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 • 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.
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
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 • E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
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