Senior Study Director - Immunotoxicology & Immunology (I&I)
Our team is growing! We are looking to add a Study Directorto our Immunology & Immunotoxicology (I&I) team in Madison, WI. At Laborp Drug Development, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in an impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities.
This lead role will:
* Have overall responsibility for the technical conduct of immunotoxicology endpoints. Monitors and maintains compliance with appropriate SOPs, GLPs, regulatory guidelines, and study-specific protocols.
* Develops protocols and ensures that the protocol, including any changes, is approved and is in compliance with the appropriate SOPs, GLPs, and regulatory agency guidelines.
* Monitors progress and status of assigned studies. Ensures that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified.
* Oversees analysis and interpretation of data, provides technical contribution to reports, ensures compliance with protocol and regulatory requirements, and submits them to the client.
* May assist in troubleshooting and solving challenging technical problems, dependent on issue and site.
* Is responsible for on time delivery targets (protocols, results, reports).
* Have in-depth and up to date knowledge of national and international GLP/GCP regulations and their application to the work area SD roles and responsibilities, and organization of multi-site studies.
* Addresses quality assurance audits relating to studies and participate in client discussions on report issues. Ensures all document/data clarifications are completed within specified timelines.
* May author scientific papers, which are published in peer reviewed journals, and presented in scientific meetings.
* May perform scientific mentoring activities (e.g.; training study specific techniques, assisting with complex analytical work/problem solving, and presenting technique seminars).
* May conduct scientific peer review for protocols and reports and provide training for other SD/CS/PIs.
* To evaluate existing departmental procedures and systems and instigates in process improvements.
Understanding of I&I assays
* Have in-depth knowledge of relevant assays; and be able to advise internal/external clients on standard study designs.
* Maintains familiarity with routine study procedures/analysis methods and becomes familiar with specialized study procedures/analysis methods.
* Remains current with assay capabilities within I&I.
Client facing roles
* Participates in client visits and activities
* Assists in assessing client interest and technical feasibility of new immunotoxicology assays.
* Works with Safety Assessment Management, client service, program management, and study direction to evaluate I&I proposals, evaluate feasibility, and provide recommendations to clients.
New assays/feasibility work
* Assists in the planning and designing of new techniques and leads method development/feasibility studies. Ensures that method development activities are properly documented and conducted in accordance with SOPs and Good Scientific Practice.
* Stays current on new and emerging technologies and discoveries and provides input on new assays being developed.
* Evaluates new techniques and systems for applicability to data collection and analysis and advises management on opportunities. Assists in implementation and training on new techniques and equipment as applicable.
* May contribute to the strategy of long-range planning and technical policies of the department both locally and globally.
* Participates in the preparation of RFIs and bid defense activities.
Come join a global leader in drug development!
Patients can't wait. Neither can we.
Experience will have been gained in study direction within the department or within a similar role external to Laborp. In addition, experience of Sponsor management and technical expertise in the relevant business line will have been gained prior to this role. The job holder will have developed skills and competencies in the basic study types.
The post holder should typically have:
* Computing skills, including word processing and use of spreadsheets (e.g. Word, Excel).
* An in depth understanding of Health and Safety policies, Company Policies and Procedures, GLP and GCP.
* Be able to communicate effectively at all levels with other Labcorp employees, as well as external Sponsors, suppliers etc.
* Skilled in conducting research, data interpretation, and writing reports.
* Some experience in performing scientific presentation and preparing scientific publications.
PhD preferred, or equivalent degree in immunology, immunotoxicology or related field, or Master's or Bachelor's degree in related discipline plus 10 years+ of experience.
Experience may be substituted for education.
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