Clinical Trial Manager - Respiratory

January 11

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Apogee Therapeutics

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Apogee Therapeutics is a clinical stage biotechnology company focused on developing novel biologics for the treatment of inflammatory and immunology disorders. The company targets major markets in inflammatory and immune diseases such as atopic dermatitis, asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, and other related conditions. Apogee Therapeutics seeks to reshape the current standard of care by advancing antibody therapeutics that target well-established biological mechanisms, with the potential to address dermatological, respiratory, and gastroenterological issues. The company is committed to creating a psychologically safe workplace while prioritizing innovative treatment options for those living with these conditions.

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

📋 Description

• We are seeking a Clinical Trial Manager (CTM), who will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). • The individual 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 will be the oversight of and partnership with CROs and other 3rd party vendors to 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. • The CTM will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. • 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(s) to ensure robust patient enrollment strategies are developed and effectively implemented, on time and within budget. • Proactively identify and manage study related risks. • Develop and manage clinical trial documents, including but not limited to protocols, Case Report Forms (CRFs), consent documents, and confidentiality agreements. • Review and manage study related plans and processes including Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, and safety monitoring. • Review CRO and vendor contracts/work orders and specifications to align with study objectives. • Review and approve essential document packages to enable timely site activation. • Work closely with Apogee CRA team to ensure sites are committed to quality and patients’ safety as well as meeting enrollment expectations. • Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs. • Ensure the study is "inspection ready" always. • Oversee and coach the functional activities of Clinical Trial Associates allocated to the project.

🎯 Requirements

• Bachelor’s degree in life science or equivalent • 5+ years of clinical project management experience in Respiratory therapeutic area with strong preference for COPD/Ashma in conducting international clinical trials in sponsor Pharma/Biotech organization • 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 • Experience with budget forecasting and management • 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 team environment • Attention to detail and commitment to quality • Experienced and enjoys building relationships with KOLs and site personnel • Demonstrated ability to build and deliver on patient enrolment strategies • Excellent interpersonal and decision-making skills • Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives • Demonstrated ability to comprehend complex scientific concepts and data • Proficient in reviewing and assessing clinical data • Possesses excellent planning, time management & coordination skills • Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs • Experience in working in a small organization • Collaborative team-player • Excellent written and oral communication skills • Ability to travel globally - Amount will vary upon project needs (up to 25%)

🏖️ Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • Flexible PTO • Two, one-week company-wide shutdowns each year • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve