Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology

Health Care

1-10 (10)

Founded 2022

$169M raised

14 open positions

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Associate Director, Monitoring Oversight Management

1 hour, 45 minutes ago

United States

Full-time

Lead

Program Manager

Project and Program Management

GCP

Apply Now

Apogee Therapeutics

Biotechnology

1-10

Founded 2022

$169M raised

View All Jobs 14

Description

Lead global Oversight CRAs to ensure study deliverables are met efficiently and in compliance with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Manage hiring, training, development, and training compliance for in-house Oversight CRAs.
Conduct and document regular team and individual meetings to share updates, align best practices, and improve consistency and efficiency.
Support creation, review, and revision of departmental SOPs, policies, processes, tools, and monitoring documents.
Contribute to risk-based monitoring strategy development and implementation across clinical studies.
Assist with monitoring resource and capacity planning across studies and therapeutic areas.
Ensure monitoring oversight activities remain inspection-ready, including Trial Master File maintenance for health authority inspections.
Review monitoring visit reports, metrics, timesheets, and expense reports, and compile clinical monitoring KPI reporting.
Resolve region-specific and site management issues and coordinate with clinical vendors and site personnel as needed.
Oversee global field management timelines, site oversight visit completion, and data integrity at clinical study sites.

Requirements

Bachelor's degree in a scientific or healthcare-related field.
8-10 years of experience as a CRA or in a related role in the pharmaceutical or biotechnology industry.
5+ years of experience leading a team of CRAs.
Experience in Phase I-III clinical trials.
Recent experience with respiratory, dermatology, and/or gastrointestinal clinical trials preferred.
Recent experience using risk-based monitoring models preferred.
Strong knowledge of ICH guidelines, GCP, and FDA regulations.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet.
Experience with EDC systems, eTMFs, and other clinical trial databases and systems.
Clinical Research Associate (CCRA) certification or equivalent preferred.
Up to 35% travel required, including mandatory in-person attendance at Apogee All Hands meetings, annual clinical operations meetings, and key Phase 3 meetings in San Francisco.
Ability to work independently and collaboratively in a fast-paced, dynamic environment.

Benefits

Anticipated salary range of $180,000-$205,000 per year.
Market-competitive compensation package with performance bonus and equity grant opportunities.
Health, welfare, and retirement benefits.
Three weeks of PTO, two one-week company-wide shutdowns each year, and dedicated paid sick leave.
Professional development support and access to resources for growth.
Regular all-team in-person meetings to build relationships and solve problems.
Opportunity to work in a fast-paced, highly dynamic environment that supports shaping the company culture.

Interested in this position?

Apply directly on the company website

Apply Now

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