Clinical Business Operations Manager

Summary

Join Apogee Therapeutics, a Nasdaq-listed biotechnology company, as their Clinical Business Operations Manager. This role focuses on providing project planning support for clinical trials within a specific therapeutic area. You will be responsible for managing clinical study plans, collaborating with cross-functional teams, and tracking key performance indicators. The ideal candidate possesses a Bachelor's degree in life sciences, 8+ years of biotech/pharmaceutical experience, and 3+ years of clinical operations experience. Apogee offers a competitive compensation and benefits package, including flexible PTO, company-wide shutdowns, and professional development opportunities.

Requirements

• Bachelor’s degree in life sciences or a related field
• Minimum of 8 years of experience in biotech or pharmaceutical industry
• 3+ years of Clinical Operations experience
• Experience working with clinical stage candidates across all phases of Clinical Development (e.g., Ph I to Ph III)
• Extensive knowledge of Smartsheet and/or Microsoft Project
• Self-starter who is confident and proactive
• Highly organized with meticulous attention to detail
• Ability to multi-task and keep pace with a fast-moving organization
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 15% travel

Responsibilities

• Develop, maintain and communicate a current overview of Clinical Operations Program status and issues
• Work with Clinical Operations team members to identify resource constraints, risks, and conflicts that could impact the team’s ability to deliver according to plans
• Provide Project Management support for 1 or more Clinical programs, including building and maintaining the clinical study plans by interfacing with our external partners
• Collaborate closely with the cross-functional Program Management team to ensure integration of Clinical Operations activities into overall program plans, monitor project deliverables and ensure tasks are on track
• Work collaboratively to create project planning guidelines/playbooks for use across projects
• Establish and track key performance indicators (KPIs) and metrics to evaluate performance and identify areas for improvement
• Document, standardize and publish department processes and procedures while seeking to identify potential operating efficiencies
• Prepare reports, presentations, and other deliverables related to project updates, process improvements, or other business initiatives
• Participate in Work Order and Change Order negotiation, review, and approval
• Submit purchase orders in NetSuite, review and approve vendor revenue recognition, accruals, and invoices
• Assist with tracking outsourced activities as needed

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• 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
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• 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