BACKGROUND

Seattle Genetics, Inc. is a biotechnology company focused on developing monoclonal antibody (mAb)-based therapies for cancer and immunologic diseases. We are seeking to hire a Sr. Manager Clinical Research.

RESPONSIBILITIES

Responsible for the supervision and management of all in-house CTAs, CRAs, and Protocol Leads/Clinical Project Managers to ensure that clinical trials are performed according to GCP guidelines and established SOPs as well as meeting corporate timelines and budgets. The successful candidate will provide mentorship for the CRAs regarding clinical project management skills and will assist the CRAs with supervision of regional monitors. Additional responsibilities include: provide operational support to core and clinical project teams; develop study budgets and timelines; contract with and oversee the management of CROs and vendors involved in clinical study conduct; oversee study conduct and administrative processes to ensure successful clinical trial conduct; participate in IND/NDA/BLA filings and reports to the FDA. This position will also interact directly with statisticians, medical writers, regulatory and data management personnel, and medical monitors. Report directly to Director of Clinical Operations; work within a clinical team structure.

REQUIREMENTS

Bachelor’s degree in scientific discipline, nursing or pharmacy with a minimum of 10-12 years of pharmaceutical, clinical or biological research of which 6-7 years should be CRA experience, preferably with knowledge of oncology drug development. Demonstrated clinical management experience with prior CRA supervision and training required. Knowledge of electronic data capture systems preferred. Current knowledge of FDA regulations and GCPs is essential. This position requires excellent interpersonal, communication, leadership, problem solving, and organizational skills, Expertise in other disciplines such as regulatory affairs, clinical marketing, and/or basic research is desirable. Must be willing to travel up to 30% to co-monitor with site CRAs.

TERMS:
Fulltime

LOCALE:
Bothell, WA

COMPENSATION:
DOE

HOW TO APPLY:
http://seagen.com/careers/index.htm OR scoleman[at]nwrpros.com