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Associate Director, Monitoring Oversight Management

2 months, 1 week ago
United States
Full-time
Lead
Program Manager
Project and Program Management
GCP
Apply Now
Apogee Therapeutics

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
1-10
Founded 2022
$169M raised
View All Jobs 20

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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