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Director, Clinical Pharmacology

3 months ago

San Mateo, California, United States BeiGene Full time

_General Description:
_

  • The Director, Clinical Pharmacology will be responsible for developing and executing clinical pharmacology and pharmacometric strategies for novel small molecules and biologics assets in the company portfolio.
She/He will provide clinical pharmacology and pharmacometric expertise for:
characterizing pharmacokinetic profiles; dose selection justification; assessing drug/food interaction potential; characterizing QT prolongation potential, etc.

This will be accomplished by implementing novel quantitative techniques and working in close partnership with other key functions such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC etc.

Responsibilities will include planning and reviewing study designs & analysis plans; analysis & interpretation of pharmacokinetic and pharmacodynamic data; and authoring and defending the clinical pharmacology sections of regulatory filings.

A working knowledge of global regulatory practices as they relate to clinical pharmacology-related areas of subject matter expertise is essential.

Communication skills at all levels of interaction must be excellent.

Essential Functions of the job:

  • Actively participate as the functional clinical pharmacology representative on project teams.
  • Develop and execute clinical pharmacology and pharmacometrics strategies to mitigate risks and support development of small molecule and/or biologics drug candidates from pre-IND and first-in- human testing through all phases of clinical development.
  • Develop clinical pharmacology study designs and collaborate with CROs and Clinical Operations to write study protocols, amendments, and reports, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines.
  • Contribute to the design and analysis of PK data from patient clinical studies.
  • Conduct hands-on clinical PK and pharmacometric data analysis.
  • Analyze, interpret, summarize, and present data to internal project teams, senior management, and to global health authorities.
  • Present data and interpretations to health authorities to enable optimal clinical development and registration of novel drugs.
  • Author, review, and finalize relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions and respond to health authority questions related to these submissions.
  • Represent Beigene in the external scientific environment - influencing partners and regulators in a positive way.
  • Provide clinical pharmacology reviews on business diligence activities.

Qualifications:
A Ph.
D.

or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline with at least eight years of industry and/or related post- doctoral experience is preferred.

Demonstrable scientific, clinical development and regulatory experience based on prior experience with NDA/BLA/MAA filings and/or publications is essential. Familiarity with DMPK studies, bioanalytical methods is preferred. Prior experience in oncology drug development is preferred.

Supervisory Responsibilities:

  • Direct management and mentoring junior members of the group as needed
  • Manage clinical pharmacology vendors, and consultants for specific project needs

Computer Skills
:
Hands-on experience in performing NCA using Phoenix WinNonlin is essential.

Experience with one or more of the following is preferred:
NONMEM, R, S-Plus, Berkeley Madonna, Simcyp, Gastroplus.

Education Required: Bachelors with 10+ years of experience or Masters with 7+ years of experience.

Travel:
Ability to travel to manage clinical pharmacology collaborations and to global health authority interactions.


All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.