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!

The Senior Director/Executive Director, Clinical Operations acts as the single point of accountability for Clinical Operations and reports directly to the Senior Vice President of Clinical Operations to ensure the integrity and success of Alpine Immune Sciences' clinical trials. This position is a key cross-functional team member contributing to the design and execution of Alpine’s clinical trials, and is responsible and accountable for ensuring there is an alignment of Clinical Operation timelines and deliverables with organizational objectives. The position provides strategic and operational leadership to ensure milestones are delivered on time, within budget, with high quality, and in compliance with all applicable regulations, guidelines, and SOPs. 

•Lead Clinical Operations Teams to expedite the execution of clinical trials with the highest level of regulatory, ethical, and safety standards.

•Participate in the design, implementation, and review of clinical protocols and study reports for scientific and operational accuracy

•Responsible for ensuring all programs are appropriately resourced with staff who have appropriate qualifications and current training 

•Ensure departmental processes and SOPs are adequate to ensure consistent, efficient, and high-quality execution of clinical studies; establish new processes as required 

•Establish excellent communication and collaboration with the cross-functional partners within the company. Serve as the escalation point of contact for internal/external team members

•Provide consistent, detailed, and accurate clinical study timelines and deliverables; work closely with Program Management to establish cross-functional corporate timelines and objectives

•Responsible for timely delivery of high-quality clinical study data, working in concert with data sciences and drug safety

•Identify, recruit, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators to prioritize enrollment and ensure timely and high-quality execution of clinical studies

•Accountable for the selection, contracting, and oversight of CROs and vendors

•Assist with strategic planning and development of the operational model for each study, including site and country selection; develop and maintain study startup and enrollment forecasts; closely monitor projections vs actuals

•Work closely with Clinical Development and other stakeholders to develop and drive patient accrual strategy to meet appropriate corporate timelines 

•Lead or assist in writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB/EC and HA submissions/approvals, site activations, monitoring plan and tools, CRF’s, DMP edit checks, safety plan, Safety Management Team and DMC charter, close-out plans, inspection readiness plans, and CSRs

•Assist with the development of study presentations, handouts, and coordination of Investigator Meetings, Advisory Boards, Study Monitoring boards. 

•Assist in writing publications and scientific presentations

•Provide operational expertise to internal teams (CMC, regulatory affairs, non-clinical, medical writing, data sciences, and drug safety) and external teams (CROs, consultants) to ensure that Clinical Development scientific and medical strategies are met

•Collaborate with Clinical Development and Finance to develop and effectively manage annual budget for clinical activities and budget forecasting

•Review contracts and work closely with the Legal department to ensure execution of contracts per company requirements and to planned timelines

•Regular presentations to the Executive Committee and other senior management meetings providing up to date clinical operation metrics

•Degree in health care or other scientifically related discipline is required. An advanced degree (e.g., Masters, MBA, MD, PhD, RN, NP, PA) is preferred

•15+ years of experience in a leadership function in clinical operations with a proven track record of people and project management; working knowledge of details and issues involved in cross-functional areas

•Experience in a scientific discipline with clinical drug development experience and strategic planning specifically in the pharmaceutical or biotech industries is preferred; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility

•Experience in immunology, inflammation and autoimmune diseases is preferred

•Demonstrated experience managing and mentoring team members. Effective leadership and critical thinking skills and proven ability to foster team productivity and cohesiveness

•Highly motivated and thrives working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient

•Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations

•Some travel (domestic and international), up to 25% and periodic travel to the Seattle HQ if employee is remote

#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!