Alpine Immune Sciences : Head of Clinical Operations (Dir., Sr., or VP)

Job ID: 1110

We are seeking a Head of Clinical Operations at either the Director, Senior, or VP level. This person will be responsible for strategic and operational leadership of all clinical operations activities in the Alpine Immune Sciences portfolio. Title and compensation commensurate with level of experience.

Key Responsibilities:

• Lead and direct all teams responsible for execution of clinical trials. As needed, lead cross-functional clinical trial team and proactively manage timeline, milestones, budget, resources, and vendors
• Assess operational feasibility of projects and studies, recommending plans for execution and/or risk mitigation
• Plan, conduct, and manage/oversee internal team and investigator meetings
• Manage or oversee the tracking, reporting, and review of study quality metrics and identify activities warranted to meet trial goals and timelines
• Identify, hire, and oversee appropriate CROs and other third party vendors
• Negotiate and manage budget, invoices, and payments with vendors and/or sites
• Manage and/or write, prepare and/or contribute to clinical protocols and amendments, ICFs, CRFs, study manuals, and other clinical research documents
• Oversee the identification, selection, and monitoring of investigational sites, including investigations of queries and discrepancies
• May hire, manage, and/or train other clinical operations personnel
• Ensure execution of trials according to the study protocol and procedures, SOPs, GCP, and regulations

Desired Skills and Experience:

• At least 10 years of clinical operations experience in a pharmaceutical/biotech setting. Successful oncology, bone marrow transplant/GVHD, or inflammatory disease experience.
• Bachelor's degree or equivalent in a science or health-related field.
• Demonstrated success in US and ex-US territories strongly preferred, e.g. including IND, CTA, IMPD, BLA/NDA, and MA submissions.
• Prior successful management experience also preferred.
• Demonstrated success at clinical operations management, including excellent presentation skills.
• Demonstrated successful management of CROs.
• Demonstrated knowledge of ICH/GCP and appropriate regulatory guidelines.
• Strong interpersonal and communication skills including attention to detail.
• Entrepreneurial, enjoys working in a fast-paced, small-company environment. Ability to function well with volatility, uncertainty, complexity and ambiguity; to take disparate inputs and drive them into one cohesive strategic regulatory decision; to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality.

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