Director - Clinical Systems

3 days ago

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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 Director of Clinical Systems as the strategic leader leading, deploying and optimizing of multiple clinical systems within the Clinical Operations organization. • This position will strategically evaluate business needs against clinical systems capabilities and partner in cross-functional collaboration activities with Information Technology (IT), internal stakeholders, external clinical system vendors and Clinical Research Organizations (CROs) to develop, manage and support the use of clinical systems including but not limited to Risk Based Monitoring, (RBM), Interactive Response Technology (IRT), Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), and Patient Reported Outcomes, (ePRO/ eCOA). • Additionally, this position will manage and assist with developing and implementing clinical system (business and technical) processes as they apply to SOPs, Work Instructions, tools, templates, and training.

🎯 Requirements

• Bachelor’s degree required • Minimum of 15 years of experience working in or partnering with a Clinical Operations Organization • Minimum of 10 years of experience in clinical systems related management including: • Veeva systems implementation and management • IxRS/IRT and related systems • CTMS and related systems • Minimum of 5 years of experience with ePro/eCOA experience • Demonstrated familiarity and use of the System Design Life Cycle (SDLC) • Successful record in leading the implementation of clinical systems • Working knowledge of Good Clinical Practices and Health Authority regulations governing clinical trial execution • Detail-oriented and able to manage many projects simultaneously • Experience with documentation in a regulated environment • Meeting management, facilitation, and negotiation skills • Extensive vendor management experience • Excellent project management and organizational skills, attention to detail and follow through • Sound problem resolution, judgment, and decision-making abilities • Highly organized with a strong attention to detail, clarity, accuracy, and conciseness • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless • Self-direction, motivation, problem solving and decision-making abilities • Demonstrated effective written and verbal communication skills with internal and external team members, and functional leadership • Able to navigate complex problems, develop advanced concepts, make decisions, anticipate challenges, and propose solutions/recommendations • Collaborate with the vendor on on-going system issues, upgrades, and maintenance • Position requires travel up to 3-4 times per quarter, based on business needs

🏖️ 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