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.