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, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse 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 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 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
• 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
• Support and liaise with clinical site personnel, as needed
• Review and approve time sheets and expense reports
• Assist with creation, review and revision of departmental SOPs and policies, as applicable
• Assist with creation and delivery of department initiatives, improvement plans and/or training

Field management responsibilities

• Conduct periodic quality visits for Senior Oversight CRAs, as needed
• Ensure all site oversight visits are completed within the expected timelines globally
• Oversee all timelines and KPIs for the oversight monitoring team globally
• Ensure the oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites

Ideal Candidate

• 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
• Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials preferred
• Experience working in Phase I – III clinical trials
• Recent experience working on trials utilizing risk-based monitoring models
• Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (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 the ability to work collaboratively in a team environment and can also work independently without significant oversight
• Experience working in a fast-paced and dynamic environment
• Certification as a Clinical Research Associate (CCRA) or equivalent preferred
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Position requires up to 35% travel including to company meetings at least twice per year

The anticipated salary range for candidates for this role will be $170,000 - $195,000 year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

What We Offer

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.

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