Vir Biotechnology
Associate Director, Clinical Pharmacology and Pharmacometrics (Temporary)
Remote - United States · Director · Contract
No sponsorship$95k-$118kDetected 1 day ago
HRIntellectual PropertyClinical TrialsClinical ResearchPharmacologyResearchAnimal Studies
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26Unrated
Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
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About the role
- You will present clinical pharmacology data and strategy to internal teams, acting as a technical expert on cross-functional project teams and sub-teams.
- Additionally, you will apply quantitative modeling approaches, including PK/PD, Population PK and exposure response analysis to guide recommended doses for Phase 2 and pivotal trials.
Responsibilities
- Supports the development of fit-for-purpose clinical pharmacology strategies to enable development and regulatory decisions from pre-IND through market authorization
- Work collaboratively with cross functional teams, including clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, and regulatory in support of program advancement
- Supports 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
- Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer.
Requirements
- 6+ years industry experience in Clinical Pharmacology and/or Pharmacometrics
- Ability to communicate complex data and concepts to diverse audiences
- Understanding of the multidisciplinary requirements for drug development and ability to work effectively across functions to enable program advancement
- Experience in PK/PD, PopPK and exposure-response modeling.
- Proficiency in R and extensive hands-on experience with Monolix or NONMEM required
- Experience working on translational and clinical pharmacology work from FIH dose selection through market authorization
- 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.
- Proficiency using standard PK analysis and graphing programs (Phoenix WNL, Graphpad, R, etc)
Nice to have
- Experience with clinical pharmacology and/or pharmacometrics strategy for oncology and/or immunology indications preferred.
- Familiarity with clinical pharmacology strategies for immune modulating agents
Compensation
- This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.
Company info
- The expected hourly rate for this position is $95.00 to $118.00 per hour.
- Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
- Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
- All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications.
- Employment decisions are made without regard to any legally protected characteristics.
- This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.
- Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
- Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology.
- Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes.
- We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
- For hires based in the United States, Vir Biotechnology, participates in E-Verify.
Visa & Work Authorization
- Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
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