Senior Principal Scientist (DMPK - Biologics) Summit United States,
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
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:
- Represent DMPK on cross-disciplinary biologics discovery and development project teams, formulating and executing project strategies in collaboration with functional teams.
- 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.
- 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.
- Have a good understanding of regulatory landscape in the areas of bioanalytical validation and testing, immunogenicity testing and pharmacokinetics/toxicokinetics.
- Write and critically review BA, Immunogenicity and PK/TK reports, functional contributions to regulatory documents in support of IND/IB, Briefing Books and registrations.
- 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.
- 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.
- Represent DMPK in interactions with regulatory agencies, collaboration partners and internal and external scientific bodies as appropriate.
- 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.
- 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.
- 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.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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