Associate Director, Monitoring Oversight Management

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 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!

 

Role Summary

We are seeking an Associator Director, Monitoring Oversight Management, to manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities for Apogee sponsored clinical trials.  This role will also support contract Oversight CRAs globally.  In this role, you will serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs and contribute to building a culture of team, site and patient centricity.  Helping Apogee become “Sponsor of Choice” with both our CRO partners and sites will be critical.  This role will also contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies.

Key Responsibilities

In-house responsibilities

• The Associate Director of Monitoring Oversight Management is responsible for the leadership of Oversight CRAs globally driving the team to ensure study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements
• Responsible for hiring in-house Oversight CRAs
• Assist with creation, review and revision of departmental SOPs and policies, as applicable
• Lead, conduct, and document regular meetings with Oversight CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency
• Assist with creation and delivery of department initiatives, improvement plans and/or training
• Create SOPs and process to support the responsibilities of the monitoring excellence organization
• Responsible for the training and development of in-house Oversight CRAs and ensuring training compliance is maintained
• Contribute to development and implementation of risk-based monitoring strategies
• Assist monitoring head with resourcing/capacity management projections across clinical studies and/or therapeutic areas
• Contribute to overall operational readiness to support clinical operations monitoring oversight activities across studies and/or therapeutic areas
• Facilitate resolution of region specific and site management related challenges
• Communication and issue resolution with clinical vendors, as needed
• Create and implement monitoring processes, tools, and documents (e.g., monitoring oversight plan, site visit report templates, monitoring tools)
• Responsible for the training and development of in-house Oversight CRAs and ensuring training compliance is maintained
• Periodic review of monitoring visit reports and metrics, as applicable
• Responsible for ensuring Oversight CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections
• Responsible for compiling and providing clinical monitoring metrics per KPIs to ensure adequate oversight of clinical monitoring activities
• Support and liaise with clinical site personnel, as needed
• Review and approve time sheets and expense reports

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