Clinical Trial Manager

 

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.” 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 Trial Manger (CTM) to join our growing Clinical Operations team! In this newly created role, you will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). You will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. A key focus is partnership with CROs and other 3rd party vendors to oversee and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines, and that the quality of data is suitable for regulatory submission/inspections. You will have visibility and regular interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. 

Key Responsibilities

• Oversee study scope, quality, timelines, and budget with the internal functional leads, CRO, and vendors to ensure overall project objectives are met 
• Initiate and build strong relationships with key opinion leaders and clinical site staff
• Partner with the CRO to ensure robust patient enrolment strategies are developed and effectively implemented, on time and within budget for assigned regions
• Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and effectively implemented to ensure delivery of high-quality data
• Proactively identify and manage study related risks
• Develop and manage clinical trial documents, including but not limited to protocols, Case Report Forms (CRFs), and consents
• Review and manage study related plans and processes including Investigator agreements (CTA), site budget review, CRFs, CRF guidelines, Statistical Analysis Plans, Pharmacokinetic Analysis Plans, Monitoring plan, Data Management Plan, and Safety Monitoring Plan
• Collaborate with Regulatory/CRO team members to assist with completion/review of regulatory submissions
• Review CRO and vendor contracts/work orders and specifications to align with study objectives
• Review specifications for systems build and participate in User Acceptance Testing (UAT) (eg, IRT, eCOA, EDC)
• Participate in data cleaning and manage database lock activities with cross functional team
• Oversee review and approve essential document packages to enable timely site activations
• Direct investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• Participate in TMF review and ensure quality and completeness throughout end of the study
• Ensure the study is always “inspection ready” 
• Oversee and coach the functional activities of Clinical Trial Associates allocated to the project 

Ideal Candidate

• Bachelor’s degree in life science or equivalent
• Minimum of 5 years of clinical trial management experience in conducting international clinical trials in a Sponsor Pharma/Biotech organization.  Biotech experience strongly preferred.  
• Prior phase II and III experience required
• A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• Proven proficiency in overseeing complex studies being managed in house and by a CRO
• Demonstrated ability to lead teams and work in a fast-paced, cross functional environment, and able to think critically and creatively
• Experience selecting and managin