Executive Director, Clinical Solutions and Compliance - Novato, CA | Biospace
Get Our FREE Industry eNewsletter

Executive Director, Clinical Solutions and Compliance

Ultragenyx Pharmaceutical Inc.

Apply
Location:
Novato, CA
Posted Date:
5/24/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Operations, Compliance, Director,

Job Description

Why Join Us?

Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.

Come join our team during this exciting time of growth and opportunities!

We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco.

Position Summary:

The Executive Director of Clinical Solutions and Compliance is accountable for defining the vision, mission and strategy for the function, which resides in the Clinical Operations organization. This position has responsibility for overseeing clinical systems, training programs and implementing appropriate processes and procedures to ensure GCP compliance and inspection readiness. The Senior Director/Executive Director will also sponsor and/or lead key strategic Clinical Operations organizational initiatives. This position can be located in our Novato, CA or Brisbane, CA offices.  

Responsibilities:

•   Build and lead the Clinical Solutions & Compliance team to create, deploy and manage Clinical Operations’ systems, process and procedures, training programs, GCP compliance and regulatory inspection activities
•   Manage the development and deployment of Clinical Operations’ Policies, Quality Standards and Standard Operating Procedures in accordance with ICH/GCP regulations and company policies to ensure inspection readiness
•   Ensure optimal relationships with key internal stakeholders, as well as vendors, to enable the successful development and deployment of Clinical Operations and cross functional Development processes, clinical systems, quality documentation and training programs, as appropriate
•   Represent Clinical Operations on the Inspection Readiness Steering Committees
•   Partner with Clinical Quality Assurance to oversee GCP regulatory authority inspections on behalf of Clinical Operations
•   Provide oversight and strategic guidance for key clinical systems, such as eTMF, CTMS and IWRS
•   Actively participate as a member of the Clinical Operations Leadership Team in the development of organizational goals and strategies
•   Lead key strategic Clinical Operations organizational initiatives by translating the vision into actionable strategies and ensuring that plans are executed per commitments. Includes the identification of process challenges, process enhancement, and training of teams
•   Accountable for the line management of Clinical Solutions & Compliance staff, including development, coaching, talent planning and performance management
•   Provide input to and rationale for department budget and maintain control of functional expenditures against department budget
•   Develop and present strategic and operational plans to senior management

Requirements

•   Bachelor degree or equivalent required (scientific or healthcare discipline preferred)
•   16+ years of experience in Clinical Research
•   Ideal candidate will have demonstrated ability in two or more of the following areas:  Clinical Quality Assurance (GCP), GCP regulatory authority inspections, process development & improvement, training & development, or clinical systems
•   Previous experience in managing a group or business unit, including the management of budgets, timelines and resources
•   Strong working knowledge and interpretation of FDA/EU and ICH – GCP regulations and guidelines
•   Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections
•   Previous experience leading key strategic functional initiatives
•   Willing to travel domestically and internationally, as needed

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.