Executive Director, Global Clinical Operations

 

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.  If this sounds like you, keep reading!

 

Role Summary

We are seeking an Executive Director, Global Clinical Operations, (GCO), who will be accountable for the strategic operational management, tactical planning, and execution of global clinical trial programs (Phases II-III). In this role you will be a key leader within Clinical Operations, driving the success of your assigned clinical trials and teams. In collaboration with leaders across the organization you will provide clinical operations expertise to a cross-functional matrix team. This position is fully remote and reports to the VP, Clinical Trial Operations (CTO).

Key Responsibilities

Clinical Operations Leadership

• Manage and plan CTO resourcing for assigned programs
• Lead, build and mentor CTO team supporting assigned program(s)
• Serve as a member on Clinical Operations Leadership Team (COLT)
• Create and support implementation of Clinical Operations processes, platforms and/or systems

Cross Functional Leadership

• Clinical operations representative on global development teams (GDT) and/or oversees direct reports serving on GDTs, ensuring clinical operations strategic and operational input to clinical development programs
• Clinical operations representative on Program Teams (PT)
• Lead problem solving and facilitate teams to identify clinical operations issues and propose solutions
• Identify critical path items and evaluate variances to propose and oversee the implementation of proactive contingency plans, when necessary
• Compile, assess, and communicate risks and optionality to support informed decision making for operational strategy
• Strong collaboration and partnership with cross functional colleagues globally (e.g., Clinical Development, Project Management, PVE, Regulatory, Biometrics, Clinical Pharmacology, CSM, Medical Affairs, etc.) to ensure on-budget, timely, high-quality delivery of the programs

Accountable for overall management of clinical trials

• Monitor the progress of projects and provide senior management with timely updates, changes in scope and resource requirements across the assigned clinical program(s)
• Work cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Serve as the central point of contact and contribute expertise for clinical trial execution on assigned protocols
• Ensure accurate tracking/reporting (dashboard) of study metrics and progress of study through completion
• Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
• Develop, review and/or consult on clinical trial documents, such as informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
• May be responsible for participating/presenting at Investigator Meetings, SIVs and other meetings

Budget/Finance/Legal

• Accountable for program level clinical operations budget forecasting, accrual management and quarterly review, ensuring tight control between study forecasts and actuals
• In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc
• Review and approve contracts, work orders and invoices prior to submission to Executive approval

Outsourcing/Procurement/Vendor Management

• Lead the creatio