Associate Director, Clinical Operations

We are seeking an Associate Director, Clinical Operations to provide operational oversight and trial management expertise, leadership, and guidance to AIS and third-party study team members for all clinical trials within the Alpine Immune Sciences (AIS) portfolio.

Key Responsibilities:                                                                                  

• Work with departmental leadership to establish strategic plans and objectives
• Help establish departmental methods, techniques, and standards for projects, programs, and people
• Assist in the preparation of investigator brochures, clinical study reports, clinical sections of regulatory filings, annual reports, etc.
• Collaborate with Quality staff to develop a quality plan for clinical trials
• Identify, hire, and oversee appropriate CROs and other third-party vendors
• Oversee selection and monitoring of clinical sites
• Develop action plans to address issues with investigators, clinical sites, or Clinical Research Associates and direct study monitoring priorities
• Help coordinate IP distribution; manage IP accountability, release, and reconciliation
• Negotiate and manage budget, invoices, and payments
• Develop trial-related training materials for AIS team members, clinical site staff, and third parties
• Track, report, and review study quality metrics and identifies activities warranted to meet trial goals and timelines
• Review clinical data listings and summary tables; oversee the generation and resolution of queries
• Oversee, plan, and conduct internal team and investigator meetings
• Write, prepare, and/or contribute to clinical protocols and amendments, ICFs, CRFs, study manuals and other clinical documents
• Ensure execution of trials according to the study protocol and procedures, SOPs, GCP and regulations

Desired Skills and Experience

• At least 8 years of trial management experience in a pharmaceutical/biotech setting; experience overseeing global clinical studies strongly preferred
• First-in-human, oncology, or inflammatory disease trial experience desired
• Bachelor’s degree or equivalent in a science or health-related field
• Demonstrated success at clinical trial initiation through completion, including excellent project management skills
• Demonstrated successful management of CROs
• Thorough knowledge of ICH/GCP and appropriate regulatory guidelines
• Strong interpersonal and communication skills including attention to detail

Alpine team members enjoy competitive salaries, equity participation (stock options) and an excellent benefits package including health and life insurance, a 401 (k), FSA and generous paid time off benefits.