Apogee Therapeutics is hiring an Associate Director, Monitoring Oversight Management to lead our global team of Oversight Clinical Research Associates (CRAs). You will manage the oversight of CRO monitoring and site management activities, serving as the primary liaison for internal Oversight and Lead CRAs. This role is critical for building a team and patient-centric culture, developing monitoring processes, and helping Apogee achieve its goal of becoming a 'Sponsor of Choice'.
What You'll Do
- Lead Oversight CRAs globally to ensure study deliverables are met efficiently, with quality, and in accordance with SOPs, regulations, GCP, KPIs, and study requirements.
- Hire and train in-house Oversight CRAs, ensuring training compliance.
- Assist with creation, review, and revision of departmental SOPs, policies, and processes to support monitoring excellence.
- Lead, conduct, and document regular team and individual meetings to disseminate updates and best practices.
- Contribute to department initiatives, improvement plans, training, and overall operational readiness for monitoring oversight.
- Contribute to development and implementation of risk-based monitoring strategies.
- Assist monitoring head with resourcing and capacity management projections.
- Facilitate resolution of region-specific and site management challenges and handle communication with clinical vendors.
- Create and implement monitoring processes, tools, and documents (e.g., monitoring oversight plan, site visit report templates).
- Periodically review monitoring visit reports and metrics.
- Ensure Oversight CRAs maintain sites as inspection ready, including the TMF, and review data for integrity, accuracy, and completeness.
- Compile and provide clinical monitoring metrics per KPIs.
- Support and liaise with clinical site personnel as needed.
- Review and approve time sheets and expense reports.
- Conduct periodic quality visits for Senior Oversight CRAs as needed.
- Ensure all site oversight visits are completed within expected timelines globally and oversee all timelines and KPIs for the team.
What We're Looking For
- Bachelor's degree in a scientific or healthcare-related field.
- Minimum of 8-10 years of experience as a CRA or related role within the pharmaceutical or biotechnology industry.
- Minimum 5 years of experience leading a team of CRAs.
- Experience working in Phase I – III clinical trials.
- Recent experience working on trials utilizing risk-based monitoring models.
- Strong knowledge of ICH guidelines, GCP, and FDA regulations.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet.
- Experience with EDC systems, electronic trial master files (eTMFs), and other clinical trial databases and systems.
- Strong understanding of clinical trial processes and study conduct.
- Excellent organizational and time management skills.
- Effective communication and interpersonal skills, with ability to work collaboratively and independently in a fast-paced, dynamic environment.
- Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless.
- Willingness to travel up to 35%, including mandatory in-person company meetings and travel to clinical sites/conferences.
Nice to Have
- Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials.
- Certification as a Clinical Research Associate (CCRA) or equivalent.
Technical Stack
- Microsoft Office Suite (Word, Excel, PowerPoint)
- Smartsheet
- EDC systems
- Electronic trial master files (eTMFs)
- Clinical trial databases and systems
Team & Environment
You will lead a team of Oversight CRAs globally, serving as the primary liaison with in-house Oversight CRAs and Lead CRAs.
Benefits & Compensation
- Market competitive compensation: $180,000-$205,000/year + performance bonus and equity grant opportunities.
- Comprehensive health, welfare & retirement benefits.
- Three weeks PTO, two one-week company-wide shutdowns a year, and dedicated paid sick leave.
- Commitment to professional growth and access to resources for development.
- Regular all team, in-person meetings to build relationships and problem solve.
Work Mode
This is a remote position.
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
