Senior Principal Scientist (DMPK - Biologics) is a senior functional leader responsible for managing scientific and technical activities, act as a DMPK thought leader and as functional representative on cross-disciplinary drug development project teams. Senior Principal Scientist role on the scientific ladder is comparable to Associate Director on the managerial ladder.
Responsibilities will include the following:
1. Represent DMPK on cross-disciplinary biologics discovery and development project teams, formulating and executing project strategies in collaboration with functional teams.
2. Act as PK and Immunogenicity scientific thought leader, apply critical thinking to identify and address emerging issues in collaboration with other functions such as Research, Toxicology, Clinical Pharmacology and Pharmaceutical Development.
3. Demonstrate experience and deep knowledge of bioanalytical methods for biologics, methods for immunogenicity testing, and interpretation of preclinical PK and immunogenicity data as part of the full data package for biologics development programs.
4. Have a good understanding of regulatory landscape in the areas of bioanalytical validation and testing, immunogenicity testing and pharmacokinetics/toxicokinetics.
5. Write and critically review BA, Immunogenicity and PK/TK reports, functional contributions to regulatory documents in support of IND/IB, Briefing Books and registrations.
6. Represent bioanalytical/immunogenicity function on clinical stage project teams, manage bioanalytical/immunogenicity aspects of clinical trials at contract research organizations, work closely with clinical pharmacologists in interpretation of data and contribute to clinical study reports.
7. Work closely with DMPK staff to maintain high quality work product that is in line with current regulatory and scientific standards; lead in identifying, evaluating and implementing novel technologies to address challenges in drug development.
8. Represent DMPK in interactions with regulatory agencies, collaboration partners and internal and external scientific bodies as appropriate.
Skills/Knowledge Required: -
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.