Head of Clinical Operations

98119, Seattle
Jun 14, 2018
Required Education
Position Type
Full time

Head of Clinical Operations  

Primary Function

Responsible for strategic and operational leadership of all clinical operations activities in the Alpine Immune Sciences portfolio.


Key Responsibilities:

·       Leads and directs all teams responsible for execution of clinical trials. As needed, leads cross-functional clinical trial team and proactively manages timeline, milestones, budget, resources and vendors

·       Assesses operational feasibility of projects and studies, recommending plans for execution and/or risk mitigation

·       Manages or oversees, plans and conducts internal team and investigator meetings

·       Manages or oversees the tracking, reporting and review of study quality metrics and identifies activities warranted to meet trial goals and timelines

·       Identifies, hires, and oversees appropriate CROs and other third party vendors

·       Negotiates and manages budget, invoices and payments with vendors and/or sites

·       Manages and/or writes, prepares and/or contributes to clinical protocols and amendments, ICFs, CRFs, study manuals and other clinical research documents

·       Oversees the identification, selection and monitoring of investigational sites, including investigations of queries and discrepancies

·       May hire, manage, and/or train other clinical operations personnel

·       Ensures 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.