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Associate Director, Methods Validation

Employer
Worldwide Clinical Trials - USA
Location
Austin, Texas, United States;Homeworking
Salary
Competitive
Start date
19 Jan 2022
Closing date
16 Feb 2022

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Discipline
Sales / Commercial, Business Development
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

What Global Talent Acquisition does at Worldwide

We are passionate and singularly focused on hiring the very best talent in the industry, whilst also providing the best possible candidate experience. Dynamic and fast-paced, we are agile, well-resourced and supported by the entire organization, which empowers us to move quickly and decisively.

Teamwork and collaboration is paramount, especially as a globally distributed, remote based team. We are at the forefront of Worldwide’s exciting growth and the nexus between candidates and opportunities.

What you will do
  • Monitor and manage method development timelines and appropriate communications for projects.
  • Actively develop reports through strong oversight, training, coaching and mentoring in scientific, technical and regulatory areas .
  • Ensure staff compliance with required training of departmental GLP, SOP, safety, and other guidelines.
  • Review analytical test methods (ATMs) for accuracy, provide responses to regulatory audits and SOP’s or other guidelines. Ensure timely release of such reports and information.

What you will bring to the role
  • Excellent communication skills to effectively relay project status including challenges to Sponsors .
  • Expert knowledge of bioanalytical methodology used in the pharmaceutical and biotechnology industries. with a focus on small molecules, peptides, and oligonucleotides utilizing LC-MS/MS.
  • Strong knowledge of drug discovery, drug metabolism, pharmacokinetics and toxicokinetics as applicable to bioanalytical activities.
  • Established record of publications and oral presentations at national scientific meetings.
  • Proven track record in the execution of the company’s business objectives, and laboratory operations towards success and growth in the area of bioanalytical methods development.

Your experience
  • D. Degree in Chemistry, Analytical Chemistry or equivalent scientific discipline.
  • Scientific management level experience required.
  • 8+ years managing methods development in support of regulated bioanalysis with expert knowledge of scientific principles and concepts.
  • Business knowledge as it relates to efficiency of processes, timely deliverables and metrics in a Life Sciences organization.

Why Worldwide



At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!

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Company

Find out more about working for our company

Worldwide Clinical Trials -hub-button

Brief Company Description; 

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 2,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Company info
Mini-site
Worldwide Clinical Trials - USA
Location
600 Park Offices Drive
Suite 200
Research Triangle Park
NC 27709
United States

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