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Senior Principal Scientist (DMPK - Biologics)

Req #: 17001745
Location: Summit, NJ US
Job Category: Research and Early Development
Work Location: 86 Morris Avenue CELSUM 07901
Organization: Celgene Corporation
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Director
Travel: Yes, 15 % of the Time
Other Locations:US- NJ- Summit East

Overview:

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.

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Skills/Knowledge Required: -

  • Demonstrated knowledge in the areas of pharmacokinetics/bioanlaysis/immunogenicity and proven track record of scientific contributions and problem solving in the areas of preclinical and clinical biologics development. -
  • Demonstrated experience in working with BA CROs and managing multiple projects and modalities -
  • Demonstrated experience and contributions to clinical candidate advancement, regulatory submissions, peer-reviewed publications and presentations and recognized role in development of novel methodologies or practices. -
  • Strategic thinker who can balance near term objectives with long term goals and outcomes -
  • Strong verbal and written communication skills; ability to clearly articulate scientific viewpoints to diverse audience.
  • Team player with mentoring ability. -
  • Ability to work effectively in a collaborative team environment where results are achieved through persuasion.

Qualifications: -

  • Degree:  Ph.D. and 10-12 years preferred post Ph.D. in biochemistry, pharmaceutical sciences, biology or related fields with extensive industry experience and track record of solid contributions in preclinical and clinical biologics drug development/pharmacokinetics/immunogenicity.
  • Years of Experience: - 10+ years of corporate pharmaceutical industry experience preferred.  -
  • Experience in a dynamic and fast paced environment is a plus. Field Knowledge: -
  • Advanced knowledge of regulatory, technical and standard industrial practices in bioanalysis for biologics/immunogenicity/pharmacokinetics and a broad knowledge base in drug discovery and development process.
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