Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!

•Independently manages and provides guidance & oversight for all components of clinical trials, from protocol development through clinical study report.

•Proactively manages and leads a cross-functional study team, including risk identification and mitigation.

•Manages CRO(s), including overseeing clinical site monitoring visits (qualification, initiation, interim, closeout), investigational site selection and site management, and coordinates other vendors involved in the trial, e.g., central lab, IRT.

•Collaborates with CRO and investigational sites, as needed, to complete and execute trial deliverables as required per protocol and contract.

•Acts as a cross functional liaison, communicates trial status and issues, to ensure trial plan aligns with business development strategies and goals are met. Escalates issues appropriately within the organization.

•Recommends and implements innovative processes to improve and impact clinical trial management and deliverables. 

•Responsible for creating and maintaining timelines, including aligning study start-up, enrollment projections, study conduct, and close-out activities with study and project goals, and using these timelines to track and manage trial progress.

•Works closely with the project team to develop the clinical trial protocol and design associated clinical forms, including electronic CRFs, SAE Forms.

•Works with the Data Sciences group to create and implement study-specific tools to ensure clean data, e.g., metrics reports, patient profiles.

•Oversees the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.

•Develops and contributes to the development of study plans and manuals.

•Helps manage clinical site budgets and contract plans for clinical trials. 

•Responsible for managing CRO/vendor budgets, including review of invoices for accuracy.

•Responsible for oversight of TMF for inspection readiness.

•Provide oversight and/or mentorship for CRAs and/or CTAs.

•Batchelor’s degree or equivalent, plus a minimum of 5 years of clinical trials experience (CTM) or 7 years of clinical trials experience (Sr. CTM), including clinical trial management, in pharmaceutical, biotech or CRO setting and clinical trial management experience. Sr. CTM candidates should have at least 2+ of those years managing clinical trial activities as a trial manager (other relevant experiences and skills may be considered).

•Must have strong knowledge of clinical drug development processes, clinical study design, study planning and management, and monitoring.

•Autoimmune, inflammation or related indication, and/or experience in immunotherapies preferred; rare disease experience also preferred.

•Experience in the planning, launching, maintenance, and closure of Phase I-IV clinical trials, including global clinical trials. 

•Experience in management of Ex-US regions, e.g., Europe, Asia Pacific.

•Demonstrated successful setup and management of CROs and associated vendors, e.g., IRT, central laboratory, imaging.

•Thorough knowledge of CFR, ICH GCP, and GDPR/data privacy requirements. 

•Self-starter comfortable working in a hybrid work environment with department and cross-functional colleagues based in different geographies.

•Resourceful with keen critical thinking skills; ability to successfully research a variety of topics, including obtaining input from colleagues to drive solutions. 

•Ability to anticipate issues and outcomes and respond strategically, proposing “outside the box”, goal-oriented solutions to challenges in alignment with project and company objectives and values.

•Ability to prioritize urgent and important tasks and take necessary actions to inform/escalate to management and stakeholders as appropriate.

•Proven leadership and interpersonal skills with the ability to work collaboratively as a member of a cross-functional team; excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment.

•Ability to review and analyze performance metrics through various systems, e.g., IRT, central laboratory, data management, etc., and drive actions toward improving results.

•Proficiency with MS Word, Excel, PowerPoint, SharePoint; Smartsheet experience a plus.

•Experience giving presentations in both department and multidisciplinary settings. 

•Leads by example and learns from mistakes.

•Effectively pivots to meet changing demands in priorities when business needs dictate.

•Completes tasks on time to meet milestones, comfortable proactively communicating to stakeholders if timelines are at risk.

•Clearly communicates milestones, risks, mitigations, and essential feedback.

•Values the input of colleagues. 

•Works efficiently without compromising quality.

•Continually seeks self and team improvement.

•Innovates and eliminates redundant, inefficient, and manual processes where feasible.

#LI-Remote

Alpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.

Our treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpine’s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.

Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Our office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.

Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges.  Join us!