Clinical Monitoring Manager

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 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.” We are a fast‑paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading! Role Summary We are seeking a Clinical Monitoring Manager to oversee in‑house Oversight CRAs that will manage CRO CRA’s oversight of clinical study site activities for Apogee‑sponsored clinical trials. This role will also support the study team in various trial‑related activities, serve as Apogee’s primary liaison with the in‑house CRAs and CRO clinical monitoring team, and liaise with clinical study sites to contribute to a culture of patient centricity. The manager will be accountable for oversight of clinical monitoring activities from site identification through close‑out, and may also conduct sponsor monitoring or co‑monitoring visits at study sites as required. Key Responsibilities In‑house responsibilities: Ensure study deliverables of in‑house CRAs are met with efficiency and quality, in accordance with SOPs, regulations, GCP, KPIs, and study‑specific requirements. May be responsible for hiring of in‑house CRAs. Assist in development of study documents (protocols, case report forms, informed consent forms). Oversee development and implementation of project‐specific processes, tools, and documents (monitoring oversight plans, site visit report templates, monitoring tools). Support training and development of in‑house CRAs and ensure training compliance. Collaborate with the study team on best practices, quality by design and operational delivery. Oversee review of monitoring visit reports and metrics, summarize for the study team, and develop corrective and preventative actions as needed. Ensure CRAs manage their site’s data with quality and integrity. Maintain CRAs’ sites as inspection‑ready, including the TMF for health authority inspections. Compile and provide clinical monitoring metrics per KPIs. Lead, conduct, and document regular meetings with the CRA team and individual CRAs. Oversee the CRA team’s performance and implement action plans; escalate issues to the Executive Director, Clinical Operations. Support and liaise with clinical site personnel as needed. Review and approve time sheets and expense reports. Assist with review and revision of departmental SOPs and policies. Assist with creation and delivery of new department initiatives, improvement plans or training. May assist with selection of appropriate clinical trial sites and investigators. Field monitoring responsibilities: Conduct CRO co‑monitoring visits or other monitoring visits (site qualification, initiation, interim monitoring, or close‑out) as required. Oversee CRO site visits to ensure compliance with study timelines, protocol requirements, and regulatory guidelines. Review data integrity, accuracy, and completeness at the clinical study sites. Escalate site‑related issues to the study team. Oversee coordination for site audit and make sites inspection‑ready as needed. Ideal Candidate Bachelor's degree in a scientific or healthcare‑related field. Minimum of 8 years of experience as a CRA or related role within pharmaceuticals, biotechnology, or medical devices. Minimum 2 years of experience leading a team of CRAs. Recent experience in respiratory, dermatology, and/or gastrointestinal clinical trials is a plus. Certification as a Clinical Research Associate (CCRA) or equivalent preferred. Experience with 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, eTMFs, and other clinical trial databases and systems. Excellent organizational and time‑management skills. Effective communication and interpersonal skills, able to work collaboratively in a team and independently. Experience working in a fast‑paced and dynamic environment. Exhibit Apogee’s C.O.R.E values: Caring, Original, Resilient and Egoless. Position requires up to 35% travel, including mandatory in‑person attendance at Apogee All Hands meetings twice per year and key Phase 3 meetings at the San Francisco office; US and international travel to clinical sites and conferences may also be required. The anticipated salary range for this role will be $150,000 – $170,000 per year, depending on experience, education, and geography. What We Offer A great culture rooted in our C.O.R.E values: Caring, Original, Resilient, and Egoless. Opportunity to work in a fast‑paced, highly dynamic environment and shape the company culture. Market‑competitive compensation and benefits package, including base salary, performance bonus, equity, health, welfare and retirement benefits. Competitive time off: three weeks PTO, two one‑week company‑wide shutdowns, and dedicated paid sick leave. Commitment to your professional growth with regular training and development resources. Regular all‑team in‑person meetings to build relationships and solve problems. E‑Verify participation: As part of the I‑9 verification of authorization to work in the U.S., Apogee participates in E‑Verify. Learn more about E‑Verify here . Apogee Therapeutics is 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. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr Apogee Therapeutics