Director, Clinical Pharmacology and Pharmacometrics (Temporary Staff-Remote) at Vir Biotechnology

United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

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Requirements

PhD or PharmD or equivalent with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or related field
8+ years industry experience in Clinical Pharmacology and/or Pharmacometrics
Deep understanding of the multidisciplinary requirements for drug development and ability to work effectively across functions to enable program advancement
Expertise in PK/PD, PopPK and exposure-response modeling. Proficiency in R and extensive hands-on experience with Monolix or NONMEM required
Extensive experience leading translational and clinical pharmacology work from FIH dose selection through market authorization
Ability to lead the design and reporting of various Phase 1 studies and contribute to Phase 2/3 studies with respect to dose selection/justification and sampling strategy
Experience contributing to clinical pharmacology plans and clinical pharmacology components of regulatory submissions as well as representing clinical pharmacology in regulatory engagements
Extensive experience with biologics, including monoclonal antibodies, bispecifics
Experience leading clinical pharmacology and/or pharmacometrics strategy for oncology and/or immunology indications preferred

Responsibilities

Lead the design, execution, interpretation and reporting of clinical pharmacology data across all stages of drug development
Work collaboratively with internal and external cross-functional teams to support the successful and timely advancement of drug development programs
Present clinical pharmacology data and strategy to internal teams, acting as a technical expert on cross-functional project teams and sub-teams
Apply quantitative modeling approaches, including PK/PD, Population PK and exposure response analysis to guide recommended doses for Phase 2 and pivotal trials
Select and execute appropriate modeling and simulation approaches (PK/PD, PopPK, exposure-response) to inform dose selection, optimization, and justification
Work closely with biometrics on preparation of analysis ready datasets
Leads development of fit-for-purpose clinical pharmacology strategies to enable development and regulatory decisions from pre-IND through market authorization
Lead the design and execution of Ph1 clinical pharmacology studies (i.e FIH, relative bioavailability, bioequivalence, hepatic impairment, renal impairment, etc)
Author and provide technical input for regulatory documents and submissions (protocols, IBs, briefing packages) and RTQs
May provide guidance to junior clinical pharmacologists in analysis and reporting of study level clinical pharmacology data and drafting of clinical pharmacology sections of protocols, CSRs, IBs
Represents clinical pharmacology and pharmacometrics on cross functional project teams

Skills

Vir Biotechnology

Develops monoclonal antibodies for infectious diseases

About Vir Biotechnology

Vir Biotechnology develops treatments that leverage the immune system to combat infectious diseases. The company uses a proprietary monoclonal antibody platform combined with machine learning to create a database of human antibodies, which aids in developing effective medicines. Their pipeline includes candidates for hepatitis B, hepatitis delta, HIV, and various viruses like influenza and COVID-19. Vir stands out by collaborating with industry leaders and organizations to accelerate scientific advancements, with the goal of transforming lives through innovative therapies.

San Francisco, CaliforniaHeadquarters

2016Year Founded

$640.6MTotal Funding

IPOCompany Stage

AI & Machine Learning, Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Comprehensive healthcare coverage

Employer matched 401(k)

Employee stock purchase plan

Childcare assistance

Tuition reimbursement

Risks

Leadership instability due to key executive resignations may disrupt operations.

Job cuts and facility closures indicate potential financial strain.

Struggles to diversify beyond COVID-19 antibody success may impact revenue growth.

Differentiation

Vir Biotechnology uses AI-enhanced capabilities for monoclonal antibody development.

The company focuses on immune system manipulation for targeted therapies.

Vir's pipeline includes a potential functional cure for chronic hepatitis B.

Upsides

Increased interest in AI-driven drug discovery benefits Vir's AI capabilities.

The rise of personalized medicine aligns with Vir's monoclonal antibody focus.

Global pandemic preparedness funding supports Vir's broad-spectrum antiviral therapies.

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