Head of Clinical Operations

Location
98119, Seattle
Posted
Jun 14, 2018
Hotbed
BioForest
Required Education
Doctorate/PHD/MD
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.