Lab Operations Director

Requisition Number: 6160

Position Title: Senior Director, Head of Laboratory Operations

External Description:

SUMMARY:  The Director, Head of Bioanalytical Sciences will report directly to the Sr VP and Laboratory Director as a member of the Laboratory Leadership Team at Worldwide Clinical Trials Early Phase Services Organization.  This dynamic individual will be responsible for the management of the bioanalytical scientific department which consists of over 70+ staff and will oversee all method development, validation, sample analysis, and study coordination studies to ensure full compliance and delivery of quality data within defined timelines to our clients in support of their drug discovery and development programs.  This individual is also accountable as a liaison for building up strong collaboration with EP commercial organization and supporting business development. 

RESPONSIBILITIES:

Tasks may include but are not limited to:

• Develop and execute strategies of talent, technology, and organizational development to ensure sustainable growth in support of worldwide business, and contribute strategic scientific decisions affecting the department, particularly as related to scientific directions for development.
• Manage group leaders and oversee activities in bioanalytical assay development, validation, study sample analysis studies conducted in the department in high quality and in compliance with Worldwide SOPs/Policies and in line with global regulatory guidelines
• Ensure that resources in his/her department are planned and dynamically allocated based on the project priorities and defined timelines
• Build strong collegial working relationships, and establish and maintain effective collaborations, with other related departments such as Bioanalytical Study Management, Laboratory Operations, Clinical Operations/CLIA lab, and QA
• Conduct performance management and develop a written plan with each leader and employee in his/her group to set mutually agreed upon career goals and monitor the performance of the employees in his/her group on an ongoing basis and make appropriate communications regarding performance to employee, management and human resources
• Inspire, motivate, and empower employees in his/her department for their career development through cross-training and rotation programs
• Foster a customer-centered culture focused on the delivery of quality data through synergized team efforts
• Participate in sponsor’s visits and audit activities, and maintain a strong relationship with our clients
• Actively contribute to Worldwide business development events/activities by providing scientific consultancy to BD colleagues and to our clients
• Promote scientific development and increase scientific visibility for his/her team through publications in peer-reviewed journals and presentations at national and international conferences/workshop
• Lead and oversee troubleshooting and issue resolution efforts by developing streamlined processes
• Contribute to unexpected investigations.

Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

• Highly developed organizational and time management skills
• Effective written and oral communication with all levels of the organization
• Strong knowledge of regulatory requirements and Standard Operating Procedures
• Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events
• Ability to use logical inferences to understand the “big picture” and long-term implications of these regulated bioanalyses and their role in drug development
• Ability to interact professionally and to work independently or in teams
• Ability to build relationships and promote teamwork

• Ability to motivate Ability to prioritize work and define steps needed to achieve assigned project goals
• Results-oriented

REQUIREMENTS:

• A person entering or being promoted to this level must have knowledge equivalent to that attained, along with a bachelor’s degree in a scientific focus, Master's or Ph.D. in biology, chemistry, or another scientific discipline, is preferred, plus a minimum of 12 years of relevant work experience in pharmaceutical and/or CRO industries, and 12 years of managerial experience. Demonstrated track record of leadership and KOL position in the bioanalytical community
• Scientific background in pre-clinical and clinical drug development across a broad range of therapeutic areas
• A track record of successful management of bioanalytical lab staff and managing teams with proven responsibility for delivery to timelines.
• Knowledge of the principles of Good Laboratory Practice and Good Clinical Practice

 

City:

State:

Employment Type: Regular

Community / Marketing Title: Lab Operations Director

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Austin, Texas US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.