Associate Director, Monitoring Oversight Management

Position Overview

• Location Type: Remote
• Job Type: Full-time
• Salary: Not specified

About Apogee Therapeutics: Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed biotechnology company founded in 2022. It seeks to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications with high unmet need. Apogee is committed to building an exceptional company culture based on its C.O.R.E. values: Caring, Original, Resilient, and Egoless.

Role Summary

We are seeking an Associate 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:

• Leadership of Oversight CRAs globally, driving the team to ensure study deliverables are met with efficiency and quality in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements.
• Responsible for hiring of in-house Oversight CRAs.
• 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 monitoring related issues.

Requirements

• (Details not provided in the original job description)

Application Instructions

• (Details not provided in the original job description)