Job Summary
Provide direct oversight of scientific and operational processes for discovery through regulated (GLP) and clinical bioanalytical services. Manage assigned scientific / operational staff and provide scientific direction, operational oversight, report on operational KPIs, and provide mentorship for junior staff. Develop and maintain client/sponsor relationships and participate in business development. Additional responsibilities include serving as the subject matter expert and primary scientific contact for internal and external clients and the on-site support of their programs, as well as ensuring the regulatory compliance of laboratory procedures, documentation, and data management.
Essential Duties and Responsibilities:
- Efficiently perform supervisory responsibilities in accordance with organizational policies and applicable laws to include interviewing, hiring, training, and development employees.
- Develop organizational strength by hiring, identifying and developing personnel who are scientifically and/or technically strong.
- Establish culture and atmosphere to maintain good retention and low turnover using available tools and metrics.
- Assist with providing costing estimates for components of applicable studies.
- Provide short and long-term solutions that support continuous improvement.
- Maintain critical thinking, troubleshooting and time management skills aligned with needs of operational areas.
- Demonstrate effective communication skills through informal discussions with peers, supervisor, team, cross-site, and externally with collaborators and sponsors.
- Ensure laboratory tasks and operations are executed in compliance with SOPs, protocols, regulatory requirements as needed.
- Review and approve Standard Operating Procedures (SOPs), protocols, policies, best practices and study procedures.
- Maintain contemporaneous knowledge of regulatory requirements.
- Effectively plan, assign and direct work within one or more operational areas.
- Establish and monitor performance metrics for one or more operational areas.
- Skillfully oversee the design, conduct, interpretation and reporting of studies as needed.
- Effectively utilize project management systems.
- Lead implementation of new procedures and refinement of existing procedures to meet current and future business needs.
- Align operational resources with the current needs in one or more operational area.
- Manage cross-service line interdependencies in collaboration with organizational leadership.
- Collaborate with multiple departments within and outside of site.
- Lead planning (resource management, budgets and study coordination) as well as track budgets and spend vs. revenue for one or more operational areas.
- Collaborate and consult with prospective Sponsors, providing scientific expertise and developing ongoing Sponsor relationships.
- Provide leadership, expert consultation and mentorship to cross-functional company teams.
- Provide vision and determines business priorities for one or more operational areas.
- Performs all other related duties as assigned.
Job Qualifications
- Education: PhD or international equivalent in a science related field required.
- Experience: 10 or more years’ experience in the contract research or pharmaceutical industry conducting scientific research. Experience in a GLP (discovery) environment required. Management experience required. Experience with financial business planning and project management experience preferred.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Other: Excellent verbal and written communication, and organizational skills. Demonstrated independent analytical and problem-solving abilities. Demonstrated proficiency in managing a laboratory area. Demonstrated knowledge and full understanding of GLP regulatory requirements and industry standards. Ability to develop and maintain client/sponsor relationships and direct client/Sponsor programs. Ability to interact appropriately with all levels of employees. Ability to work effectively as a member of a team. Ability to work in a dynamic, detailed driven environment. Ability to apply leadership, negotiation, interpersonal, and managerial skills. Ability to handle multiple projects, prioritize work and meet deadlines. Computer proficiency in MS Word, Excel, Outlook, instrumentation and analysis software.
- This position may require occasional travel.
Workplace Requirements:
- While performing the duties of this job, the employee must be able to perform general office and/or laboratory procedures, which require, talking, hearing, standing or sitting for long periods of time, typing/entering data into a computer, using appropriate instruments, reaching with hands and arms, and wearing safety equipment (PPE) according to OSHA regulations and company standards.
- Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
