Associate Director, Regional Clinical Trial Operations

Company: HCPro, Inc.
Location: Bothell
Posted on: September 17, 2020

Job Description:

Associate Director, Regional Clinical Trial Operations

Associate Director, Regional Clinical Trial Operations Description

Description

Summary:

The Associate Director, Regional Clinical Trial Operations is a critical role responsible for leading the Regional Clinical Trial Operations (RCTO) team in trial execution of all trials within a molecule or therapeutic area and in helping build the strategic vision of the team. This position will take a primary role in providing leadership and oversight of Clinical Trial Managers and Clinical Research Associates.

Principal Responsibilities:

Project and Management Responsibilities

May lead RCTO activities on all phases and complexity of trials from First to Human to Global Phase 3

Represents Regional Clinical Trial Operations in senior level, cross-functional teams and committees

Reviews molecule and study level documents, such as the protocol, Investigator Brochure, Pharmacy Instructions, Case Report Form and Inform Consent Form

Along with the Director, Regional Clinical Trial Operations, establishes a strategic vision and long-range plan for the RCTO team

Determines the best utilization and the optimal organization of the RCTO infrastructure and staff

Helps build strong Regional Clinical Trial Operations teams and makes decisions on selecting RCTO staff

Directly manage a large RCTO team that may include Clinical Trial Managers and Clinical Research Associates

Provide RCTO staff with appropriate coaching, mentoring and development

Participate in the preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections

Serve as Subject Matter Expert in one or more area. May be internal or external-facing and may be cross-functional

Primary contact for CRO’s Clinical Trial Site Monitoring Team. Oversees CRO’s performance in site management ensuring compliance to the protocol, terms of the contract, CFR, ICH/GCP, and overall quality of work

Infrastructure Development and Maintenance

Develops new or leads the improvement of existing department systems and processes

Leads the implementation of process improvements or of new process across RCTO

Develops or improves SOPs and training guides applicable to a global organization

Ensures consistency and best practices are followed on all processes, protocols, and clinical systems, such as within the Clinical Trial Management System (CTMS) and electronic Trial Master File

Ensures proper training is implemented to demonstrate CFR, GCP/ICH compliance

Participates in the selection of vendors and Contract Research Organization (CRO) services as required

Leadership & Functional Competencies

Must demonstrate high-level leadership skills and proactive communication. Ability to build, engage and energize the team and set high performance expectations

Ability to work successfully in a mid-stage biotechnology culture where a premium is placed on delivering science-based results in an entrepreneurial, fast moving and a sometimes resource constrained environment

Qualifications:

BA/BS or equivalent or any relevant and qualifying training with a minimum of 11 years of relevant clinical trial management experience. Advanced degree preferred

Must have significant regulatory experience spanning Phase I-III trials, preferring past participation in an NDA or BLA process

Must have significant experience managing global trials

Oncology trial experience preferred, or experience with trials in similar disease states

Proven ability to effectively manage a large staff of Clinical Trial Managers and CRAs

Intense drive and exceptional organizational expertise are necessary to manage the diverse group of functional activities. Ability to proactively handle multiple tasks simultaneously are required

Proficiency in CFR, GCP/ICH and regulatory issues is essential

Education:

BA/BS or equivalent or any relevant and qualifying training with a minimum of 11 years of relevant clinical trial management experience. Advanced degree preferred

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com .

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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Job Information

Job ID: 54666613

Location:

Seattle, Washington, United States

Position Title: Associate Director, Regional Clinical Trial Operations

Seattle Genetics is a biotechnology company focused on developing and commercializing innovative, empowered antibody-based therapies for the treatment of cancer. We are the industry leader in antibody-drug conjugates (ADCs), a technology designed to harness the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells. ADCs are intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy, while potentially enhancing antitumor activity. In ...

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Keywords: HCPro, Inc., Seattle , Associate Director, Regional Clinical Trial Operations, Other , Bothell, Washington