Scientific Director, Clinical pathologist - Belgium
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- Provide scientific review of clinical pathology data to ensure timely delivery, meet the agreed metrics and timeliness for completing interpretation and reporting of Clinical Pathology data from Toleration Studies, Outsourced GLP Studies and studies from Discovery Projects, TAs, Investigative &Mechanistic Toxicology and company supported Consortia Safety Bio-marker Initiatives.
- In addition, provide insights and identify the scientific and technical resources needed to develop novel translational safety bio-marker assays e.g., coagulation assays, that may be required for both discovery and development projects (at varying phases of development) within the space from Lead Optimization to Human clinical studies.
- Work collaboratively globally, within the Clinical Pathology group to strengthen the scientific and technical expertise in new technologies such as Molecular Immunoassay, Multi-Plex Luminex Technology and Flow Cytometry.
- Well-rounded knowledge and demonstrated competence in all aspects of Clinical Pathology (Hematology, Clinical Chemistry, Urinalysis) with recognized expertise, experience and knowledge with data driven approach to initiate hypothesis-testing aimed at resolving pre-clinical or clinical issues of safety concern that could impede progression of drug candidates.
Roles and Responsibilities:
- Provide scientific leadership globally to the Clin Path Lab groups (US &BE) and through collaboration with Inv & Mech Tox, others groups within PD&S, Therapeutic Area & Drug Discovery Teams.
- Provide well-written concise Clinical Pathology reports that accurately and completely reflects the data collected and the significance/impact on candidate drug development, drug registration and human safety.
- Review study protocols and make recommendations regarding the design of the clinical pathology portions of toxicology studies.
- Support drug discovery and development globally by contributing knowledge and scientific expertise to understanding potential mode of action for toxicity in pre-clinical studies that includes scientific input in the design and conduct of toxicology experiments that focus on characterizing the safety of novel therapeutic utilizing both routine/novel clinical pathology endpoints for translational human safety monitoring.
- Globally collaborate with Pathologists and other scientists in the design, interpretation and communication of study findings and provide the appropriate context of the data and its impact on the discovery program as well as clinical development.
- Active participation on the Global Safety Bio-marker Steering Committee to help drive scientific and technical support to the End-to-End approach for Safety Bio-marker Assays development to resolve issues of target organ related toxicity.
- Using innovative clinical pathology-based approaches and techniques contribute to the identification of new “safety” biomarkers and assist in the design and execution of appropriate qualification and validation criteria.
- Develop collaborative partnerships to exploit the use and application of innovative platforms and technologies aimed at improving pre-clinical to clinical translation of Safety Biomarkers.
- The successful candidate must have a DVM and preferably a PhD, and is board certified by European/American College of Veterinary Pathologists (ECVP or ACVP).
- Current working knowledge and experience in the field of pre-clinical GLP toxicological pathology/clinical pathology is desirable.
- A solid scientific publication record, 3-5 years of experience in the field excellent written and communication skills and recognized knowledge and expertise in the field of clinical pathology is required.