Executive Director, Global Clinical Operations
Apogee Therapeutics, Inc. - Common StockJob Description
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 is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.
We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.
If this sounds like you, keep reading!
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
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