Senior Director, Laboratory Sciences
8 - 10 years experience • Biotech/Pharma
Direct the science and business involved in the conduct, direction and execution of Laboratory Sciences operations and studies. Provide scientific direction, oversight, and guidance to staff. Maintain and implement efficient processes and procedures to provide high quality standards of study design and timely reporting. Continue to build preclinical and clinical bioanalysis and biomarkers capabilities in an effort to expand the client base. Serve as primary expert for Laboratory Sciences within the scientific community presenting and speaking at meetings and interacting with new and perspective clients. Keep abreast and maintain a broad knowledge of state-of-the art principles and theories.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Direct and oversee department activities to ensure achievement of department objectives.
- Provide senior level review of protocols, reports and related documents for appropriate scientific content and interpretation in collaboration with other senior staff.
- Oversee and ensure report timelines are maintained and perform quality assessments to ensure high quality study design and timely reporting.
- Lead interactions for Nevada Laboratory Sciences with Sponsors, consultants and other outside contacts; interact with government representatives and Sponsors when site visits are conducted.
- Lead and promote new business development for Laboratory Sciences in Nevada as the primary scientific expert for existing and new clients. Continue to build preclinical and clinical bioanalysis and biomarkers capabilities in an effort to expand the client base.
- Be seen as a recognized expert in the areas of scientific expertise in Laboratory Sciences. Deliver scientific presentations lead and/or participate in industry groups and participate in the discussions and writing of scientific guidance for industry.
- Identify key regulatory requirements and guidelines that pertain to preclinical and clinical testing and specialty services that we provide.
- Evaluate opportunities for new technology, and implement new scientific initiatives to add additional or expanded services in Laboratory Sciences.
- Ensure departmental policies, practices and procedures adhere to GLP/FDA regulations as they relate to the conduct of preclinical studies. Establish new policies and practices to ensure compliance with all applicable regulations and corporate policies.
- Ensure coordination of study bids, study design and conduct, protocol review, consultant interactions, staffing needs, analysis, and reporting of Laboratory Sciences studies.
- Represent the organization to industry groups, key customers, representatives of government and regulatory agencies and the general public.
- Ensure a positive employee relations position is maintained and that effective communication is maintained to inform employees of plans and progress.
- Anticipate problems and initiate improvements.
- Maintain up-to-date knowledge of current industry practices.
- Contribute to recruitment of research scientists and support staff. Contribute to overall facility management Interview and select qualified exempt-level departmental personnel. Recommend, review and approve personnel actions, including hiring, promotions and raises. Partner with Human Resources in the handling of disciplinary issues. Prepare and/or approve appropriate personnel action paperwork.
- Ensure that management training and development needs are identified and programs initiated. Direct the development of departmental orientation and other training programs.
- Monitor performance of direct reports. Provide regular coaching and counseling. Prepare and deliver salary and performance reviews. Review and approve performance and salary appraisals initiated by direct reports.
- Monitor and determine appropriate levels of departmental overtime. Review and approve vacation/time off requests for direct reports.
- Develop short- and long-range operating objectives, organizational structure, and staffing requirements. Oversee the development of a departmental plan for backup and succession of key departmental personnel.
- Develop and recommend departmental budget. Authorize expenditures in accordance with budget. Approve budget and expenses of subordinates.
- Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
- Direct the development and communication of departmental systems, SOPs, policies and procedures. Partner with Human Resources to develop and approve departmental job descriptions; ensure communication of duties and responsibilities to employees.
- Develop business leads to ensure the company’s financial success.
- Train and mentor scientific staff.
- Perform testing facility management duties for the site as delegated by PCS senior management.
- Perform all other related duties as assigned.
- Education: Masters Degree in immunology, biochemistry or a related scientific discipline required. PhD preferred.
- Experience: 10 years relevant laboratory experience in a contract research organization (CRO), biotechnology, or pharmaceutical environment, working to Good Laboratory Practice (GLP) standards. 5 years management experience, including staff management and development, and financial responsibility including budgets.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute.
- Certification/Licensure: None
- Other: Management and problem solving skills. Demonstrated abilities in analytical, quantitative and critical thinking. Ability to handle multiple projects, meet deadlines and make executive level decisions. Detail oriented, flexible with the ability to work well in a team-oriented environment. Proven ability to work in a dynamic, deadlinedriven environment. Proficient project management, presentation, and communication skills. Proficient with computers and standard application software.
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet