COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We are recruiting for our Early Development Unit in Harrogate and are currently seeking to hire a Study Director III to help support the Immunology & Immunotoxicology team. This is a full time and permanent contract.
The Study Director in Immunology and Immunotoxicology department (I&I) will have an overarching view of all aspects of acquisition, analysis, reporting and interpretation of I&I data. This senior position is responsible for establishing and maintaining the highest level of quality in data capture and interpretation and reporting, and provides advice and support to external and internal customers involved with I&I.
Ideal candidate should have a recognized knowledge for the mechanisms of Immunology and Immunotoxicology as well as knowledge of key technologies such as flow cytometry, cell based in-vitro and ligand binding assays that drive this interpretation.
The Study Director has a responsibility to conduct work in compliance with applicable regulatory requirements, and specifically those regulations (e.g. GLP or GCP) specified in the study plans, protocols or working agreements governing the work in which they are involved.
Essential Job Duties:
- This is a senior-level position in I&I group that provides scientific support to Study Direction, Management, Principal Investigators, and Contributing Scientists.
- Leads new technical capabilities for Immunology and Immunotoxicology (I&I) group, implements systems/processes, and trains technical personnel after development of the technology.
- Plans and leads I&I scientific discipline within the laboratory and specific scientific application for I&I studies. Monitors and maintains compliance with appropriate SOPs, GLPs, regulatory agency guidelines, and study-specific protocols.
- Plans and leads Research and Development projects in response to needs identified by Covance Management, Study Direction and clients. Stay current on new and emerging technologies. Evaluates new techniques and systems for applicability to data collection and analysis and advise management on opportunities.
- Contributes towards business, financial and commercial plans for new technologies being developed for I&I data acquisitions studies.
- Acts as a primary liaison with laboratory activities and provide input and assistance for new methods/assays being developed for I&I studies.
- Mentors, trains, and serves as primary resource for staff engaged in development of I&I laboratory methods and techniques.
- Implement and validate new techniques and instrumentation to improve I&I operations.
- Monitors, evaluates, and reviews the scientific performance of I&I acquisition, analysis, and reporting.
- Works in partnership with Operations team in preparing I&I SOPs and other relevant documentation.
- Is responsible for preparing I&I analysis SOPs, and translates new technical skills to appropriate Covance staff after development of technique.
- Trains and provides technical oversight to individuals in I&I procedures, analysis, and evaluation techniques.
- Participates in the planning, marketing, and project activities for assigned technologies, capabilities and service lines.
- May liaise with client service, program management, and study direction to evaluate I&I proposals, evaluate feasibility, and provide recommendations to clients.
- Monitors progress and status of I&I studies. Ensures that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified.
- Oversees analysis of data, provides technical contribution to reports, ensures compliance with protocol and regulatory requirements, and submit them to the client.
- May lead client facing activities and represent I&I .
- Coordinates and may lead a scientific team to conduct complex and challenging feasibility/development studies.
- Provides a leadership role in in managing technical problem resolution and communication of impact.
- To attend meetings and seminars where appropriate and to prepare and present papers on suitable topics to help in establishing Covance's scientific reputation, collaborating with others as required.
- May serve as Contributing Scientist for I&I applications in toxicology studies.
- May author scientific papers, which are published in peer reviewed journals, and presented in scientific meetings.
- Expected perform scientific mentoring activities (e.g.; training staff/clients on I&I capabilities, assisting with complex analytical work/problem solving; and presenting technique seminars).
- Expected to contribute to the strategy of long-range planning and technical policies of the department both locally and globally.
- Keeps study direction management informed of problems/issues as they unfold in assigned studies.
- Participates in the evaluation of enquiries and preparation of proposals.
- Participates in the preparation of RFIs and bid defense activities.
- Identify and implement new business opportunities and develop new service lines.
- Develops and sustains multi-disciplinary relationships with other Covance departments or sites.
- Expected to collaborate with scientists either on or off-site, when required.
- Responsible for the scheduling and management of individual workload.
- Performs other related duties as assigned.
- At least (10+) ten years of related experience. Relevant experience may be substituted for education.
- Customer service skills.
- Skilled in conducting research, data interpretation, and writing reports.
- Experience and knowledge of relevant instrumentation.
- Some experience in performing scientific presentation and preparing scientific publications.
- Demonstrated leadership skills
- Prior experience in I&I procedures, method development, and validation preferred.
- Knowledge of GLP/GCP and regulatory agencies is required.
- Knowledge of computer validation process.
- Ability to interact effectively with all staff and management levels.
- Problem solving and decision making skills.
- Strong English writing and communication skills.
- Knowledge of laboratory automation software, system software, and Microsoft applications.
- PhD preferred, or equivalent degree in immunology, Immunotoxicology or related field, or Master’s degree in related discipline plus 10 + years of experience.
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