Senior Director, Head of Clinical Pharmacology

The role

The Senior Director, Head of Clinical Pharmacology will lead technical and operational aspects of the department for infectious disease and oncology programs. This role involves managing a team and working with cross-functional teams to support drug development from preclinical to market authorization.

What you will do

• Oversee clinical pharmacology and translational PK/PD operations across all stages of development
• Represent clinical pharmacology and translational PK/PD as technical expert on cross-functional project teams
• Develop clinical pharmacology strategies to enable development and regulatory decisions
• Select and execute modeling and simulation approaches to inform dose selection and optimization
• Author and provide technical input for regulatory documents and submissions
• Work collaboratively with cross-functional teams including clinical research, CMC, and regulatory
• Establish and manage collaborations with external vendors and partners
• Generate and manage departmental budget and optimize resource allocation
• Manage and develop the Clinical Pharmacology and Translational PK/PD team

Required qualifications

• PhD, PharmD, or MD
• Mastery of nonclinical and clinical pharmacokinetic concepts and methodologies
• Expertise in PK/PD, PopPK and exposure-response modeling
• Extensive experience leading translational and clinical pharmacology work from candidate 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
• Proficiency using standard PK analysis and graphing programs
• Proven ability to manage and develop teams

Nice to have

• 13+ years industry experience in Clinical Pharmacology, DMPK and/or related fields
• experience in oncology indications

Benefits

• compensation
• bonus
• equity
• health and welfare benefit plans
• non-accrual paid time off
• company shut down for holidays
• commuter benefits
• 401K match
• lunch each day in the office

Before you apply

• Applicants must currently be authorized to work for any employer in the U.S.
• Unable to sponsor or take over sponsorship of an employment Visa at this time
• Vir Biotechnology participates in E-Verify

About the company

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing medicines for serious infectious diseases and cancer.