Senior Director, Head of Clinical Pharmacology
About The Position
Vir Biotechnology is seeking an experienced Senior Director of Clinical Pharmacology to lead the technical and operational aspects of the department and support programs across preclinical and clinical development. The role spans infectious disease and oncology programs and combines hands-on scientific leadership with management and development of a team. The Senior Director collaborates with internal and external cross-functional teams and consultants to advance drug development programs, applying best practices and innovative techniques to support successful clinical studies. This position reports to the VP of Translational Development.
Requirements
- PhD, PharmD, or MD with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or a related field.
- 13+ years of industry experience in Clinical Pharmacology, DMPK, and/or related fields.
- Mastery of nonclinical and clinical pharmacokinetic concepts and methodologies, with a deep understanding of multidisciplinary drug development requirements.
- 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 supporting 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.
- Current authorization to work for any employer in the U.S.; the company is unable to sponsor or take over sponsorship of an employment visa.
Nice To Haves
- Experience in oncology indications is strongly preferred.
Responsibilities
- Oversee clinical pharmacology and translational PK/PD operations and deliverables across all stages of development for infectious disease and oncology programs.
- Represent clinical pharmacology and translational PK/PD as a technical expert on cross-functional project teams and provide strategic input to program advancement.
- Develop fit-for-purpose clinical pharmacology strategies to support development and regulatory decisions from pre-IND through market authorization.
- Select and execute appropriate modeling and simulation approaches, including PK/PD, PopPK, and exposure-response, to inform dose selection, optimization, and justification across all phases of drug development.
- Author and provide technical input for regulatory documents and submissions, including protocols, IBs, briefing packages, INDs, NDAs/BLAs, and responses to questions.
- Collaborate with clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, research, and regulatory teams to support program advancement.
- Establish and manage collaborations with external vendors and collaborating partners.
- Generate and manage departmental budgets 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.
Benefits
- Compensation, bonus, and equity.
- Health and welfare benefit plans.
- Non-accrual paid time off.
- Company shutdown for holidays.
- Commuter benefits.
- 401K match.
- Lunch each day in the office.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
