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Senior Director, Clinical Pharmacology and Translational PK/PD
- San Francisco, California, United States
- San Francisco, California, United States
À propos
Vir Biotechnology is looking for an experienced Sr. Director of Clinical Pharmacology and Translational PK/PD to lead the technical and operational aspects of the department in support of programs across all stages of preclinical and clinical development. You will work across Vir Bio's portfolio of infectious disease and oncology programs, providing hands-on leadership while managing and developing a team. In this role, you will work collaboratively with internal and external cross-functional teams and consultants to support the successful and timely advancement of drug development programs. You will evaluate and apply best practices and innovative techniques to foster successful execution and outcomes of clinical studies. You will report to the VP of Translational Development.
This role is located in our San Francisco headquarters with an expectation of at least 3 days per week in office.
What You'll Do- Oversee clinical pharmacology and translational PK/PD operations and deliverables across all stages of development for both infectious disease and oncology programs
- Represent clinical pharmacology and translational PK/PD as technical expert on cross-functional project teams and provide strategic input to program advancement
- Develop fit-for-purpose clinical pharmacology strategies to enable development and regulatory decisions from pre-IND through market authorization
- Select and execute appropriate modeling and simulation approaches (PK/PD, PopPK, exposure-response) to inform dose selection, optimization, and justification for Phase 2 and pivotal trials
- Author and provide technical input for regulatory documents and submissions (protocols, IBs, briefing packages, INDs, NDAs/BLAs) and responses to questions
- Work collaboratively with cross-functional teams, including clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, research, and regulatory in support of program advancement
- Establish and manage collaborations with external vendors and collaborating partners
- Generate and manage departmental budget(s) and optimize resource allocation across multiple programs
- Manage and develop the Clinical Pharmacology and Translational PK/PD team, including hiring, mentoring, and building departmental capabilities to support organizational needs
- PhD, PharmD, or MD with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or related field with 13+ years industry experience in Clinical Pharmacology, DMPK and/or related fields
- Mastery of nonclinical and clinical pharmacokinetic concepts and methodologies with deep understanding of multidisciplinary drug development requirements
- Expertise in PK/PD, PopPK and exposure-response modeling with proficiency in R and extensive hands-on experience with Monolix or NONMEM
- Extensive experience leading translational and clinical pharmacology work from FIH dose selection through market authorization
- Strong understanding of regulatory requirements and experience contributing to regulatory submissions and engagements
- Working knowledge of bioanalytical techniques in support of clinical development of small molecules and biologics
- Experience with biologics, including monoclonal antibodies and bispecifics required; experience in oncology and/or infectious disease indications strongly preferred
- Proficiency using standard PK analysis and graphing programs (Phoenix WNL, Graphpad, R, etc.)
- Proven ability to manage and develop teams
Compétences linguistiques
- English
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