- Provide overall scientific and operational leadership to the site toxicology organization overseeing toxicology scientific resources and toxicology study operations at the site.
- Serve as a member of the Global Toxicology Governance Committee to resolve issues and identify and advance standardization/optimization of toxicology operations and procedures.
- Supervise Study Directors, Study Operations and Archives in their interactions with Sponsors, design of studies, preparation of protocols, interpretation of data and preparation of study reports.
- Assist with Study Director assignments and workload balancing, study scheduling, and report tracking.
- Foster the training, professional development and scientific credentials of the Toxicology department at the site.
- Institute processes to optimize toxicology study execution.
- Represent our company and the site to potential new clients.
- Work closely with direct and indirect reports to achieve/maintain a high level of integrity in all aspects of customer service, effective communications and study execution.
- Develop and implement plans/actions to continuously identify and reduce costs in toxicology and related areas.
- Contribute to the development of major business proposals for key clients as required.
- Perform Testing Facility Management duties as delegated.
- Direct activities of assigned group(s) to ensure optimum performance of the group/function.
- Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
- Develop short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
- Integrate activities with those of other major organizational units (e.g. segments, departments, functions).
- Develop and recommend departmental budget and authorize expenditures.
- Develop and oversee the implementation of departmental training programs, including orientation.
- Support the policy of equal employment opportunity through affirmative action in personnel actions.
- Partner with site senior leadership team in the development and implementation of succession plans of key toxicology personnel.
- Responsible for ensuring client expectations are met and issues involving study conduct or reporting are resolved in a way that maximizes client satisfaction.
- Direct the development and communication of systems, SOPs, policies and procedures, as appropriate.
- Perform all other related duties as assigned.
Study Director Duties
- Serve as a Study Director when appropriate.
- Generate study protocols for various regulatory guidelines and obtain sponsor approval.
- Assure that the protocol, including any change, is approved as provided by the GLP’s and is followed.
- Supervise the conduct of the studies; assures all applicable good laboratory practice regulations are followed.
- Assure that all data for the studies are accurately recorded and verified.
- Keep both management and the sponsor informed as to any significant protocol changes or circumstances that may affect the quality and integrity of the study and documents the corrective action taken.
- Interpret, analyze, document and report the results for toxicology studies.
- Ensure that at the end of the study all raw data, supporting documentation, protocols, specimens and final reports are archived.
- May act as an interim or alternate study director in the event the assigned study director is unavailable.
- Submit reports in a timely fashion.
- Perform all other related duties as assigned.
Safety and Health
- Conform to all relevant safety information, within area of responsibility, including use of specialized safety equipment required by Standard Operating Procedures (SOP), protocols, and OSHA regulations.
- Reduce or eliminate possible hazards with input from Health and Safety Officers on any new or changed procedures in the work place.
- Inform affected employees of special safety precautions via verbal and written notification and see that any additional safety training is provided prior to the conduct of the study.
- Responsible for appropriate safety gear worn by employees.
- At least ten years of relevant scientific and management experience in the pharmaceutical or contract research fields in a GLP environment in scientific and project management roles.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Certification/Licensure: Board Certification in Toxicology (D.A.B.T.) highly desired.
- Ability to critically evaluate written scientific documents for overall quality, clarity of presentation, and acceptability of scientific interpretation.
- Ability to handle multiple projects, prioritize work and meet deadlines.
- Excellent written, verbal and problem solving skills.
- Good interpersonal skills which are conducive to effective communication and delegation
Equal Employment Opportunity