Über diese Associate Director, Clinical Pharmacology and Pharmacometrics (Temporary) Stelle bei Vir Biotechnology
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. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.
Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.
THE OPPORTUNITY
Vir Biotechnology is looking for an Associate Director, Clinical Pharmacology and Pharmacometrics (Temporary Staff) who will support the design, execution, interpretation and reporting of clinical pharmacology data across all stages of drug development. In this role you will work collaboratively with internal and external cross-functional teams to support the successful and timely advancement of drug development programs. 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.
WHAT YOU'LL DO
- Represents clinical pharmacology and pharmacometrics on cross functional project teams
- 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
- 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
WHO YOU ARE AND WHAT YOU BRING
- PhD or PharmD or equivalent with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or related field
- 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.
- Experience with clinical pharmacology and/or pharmacometrics strategy for oncology and/or immunology indications preferred. Familiarity with clinical pharmacology strategies for immune modulating agents
- Proficiency using standard PK analysis and graphing programs (Phoenix WNL, Graphpad, R, etc)
WHO WE ARE AND WHAT WE OFFER
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.