The Laboratory Director will perform monitoring and site management activities for clinical research projects to assess the progress of clinical projects and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and all applicable local and federal regulatory requirements. Performs all tasks routinely and independently. Mentors and/or trains, as well as may assume line management responsibilities for less experienced employees. May assume clinical functional leadership tasks as assigned, acting as Lead CRA for a project.
- Leads and manages all laboratory staff, for both the biomarker and safety laboratory operations and deliverables
- In conjunction with Clinical Sciences staff, develops biological markers of pharmacodynamic and effect and disease models to support new drug development in humans and to support regulatory filings.
- Leads the development, validation and performance of biomarker methods and routine clinical safety analyses to support the clinical development of drug candidates.
- Develops and maintains quality processes and SOPs in the laboratories, ensuring that all temperature records, calibrations and certifications of instruments and equipment are sustained.
- Develops and enforces policies to assure biological, chemical, and general safety in the labs.
- Assures accurate collection and processing of biological specimens to assure quality of analytical data.
- In conjunction with the Medical Director and Groton Clinical Sciences, establishes policies on scientific and operational practices and assures exemplary scientific and ethical standard.
- Assures compliance of all activities with applicable regulations and guidelines.
- Delivers high quality, validates methods and laboratory data to Groton Clinical Sciences.
- Recruits, trains, appraises, and provides for career counseling / development of staff including continued competency.
- Develops and maintains unit capability by assuring that facilities and equipment are properly maintained, validated, and periodically updated.
- Involved in the creation and implementation of global and local SOPs, ensuring staff are trained.
- PhD in chemistry or the biomedical sciences preferred.
- Previous direct work experience (5+ years) managing a laboratory in a health care or pharmaceutical setting; expected experience in analytical techniques and full knowledge of analytical validation procedures.
- Experience with clinical trial operations.
- Significant track record of experience and accomplishment in clinical and/or research laboratory setting.
- Demonstrated leadership ability and supervisory experience.
- Good interpersonal skills.
- Through knowledge of OSHA requirements related to safe operation of laboratories.
- Thorough knowledge of clinical pharmacology and regulatory requirements (GCP, GLP, CLIA).
- Experience leading teams and motivating direct and indirect staff
- Proven ability to accept, accommodate and manage change in a fast-paced high-stress setting.