Vir Biotechnology, Inc.
Associate Director, Biosample Operations
Vir Biotechnology, Inc., San Francisco, California, United States, 94199
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. Vir's clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to multiple oncology programs. Vir also has a preclinical portfolio of programs across a range of other infectious diseases and oncologic malignancies.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results.
THE OPPORTUNITY:
Supporting the development portfolio, the Associate Director, Biosample Operations will planall project management and operational activities required to operationalize the VIR biomarker strategies (PK, ADA, PD, Exploratory Biomarker and CDx) for programs across the VIR portfolio. You will ensure continuity and integrity across projects, coordinate assay development and implementation activities and acts as the primarycontact for projects requiring biomarker and diagnostic activities including collection, delivery and assay testing of all biosamples within one or more clinical projects or clinical studies. You will also be responsible for any biomarker and CDx sub-team meeting management, dashboards, following up on actions, organizing meetings and tracking biomarker deliverables. In addition to the core biomarker activities, you will be involved in some clinical operation activities for clinical site management in the context of biomarker sample collection education and compliance at clinical sites.
This role will report to the VP, Clinical Operations Oncology
This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.
WHAT YOU'LL DO:
Drive the implementation and execution of the clinical biomarker and diagnostic plans for therapeutic programs in early and late stage clinical development across therapeutic areasAccountable for project management and appropriate planning of related biomarker analysis and samples management costs within a project(s) or clinical studiesPlan and implement the PK and biomarker and diagnostics biosamples collection within a project(s) or clinical study including definition of the appropriate material, instructions, lab manual development Kit development, database set up, etcEnsure the timely and efficient delivery of all biosample, including scheduling analyses with relevant vendors, sample processing and shipment, analysis, data delivery and final sample disposition.Serve as vendor operations lead with central lab and other ancillary labs and will oversee sample shipment and coordination of sample analyses, data transfers and sample reconciliationBe the first contact for PK biomarker and diagnostics biosamples operational questions and issues within a project(s) and coordinates with internal and external partnersProvide guidance during protocol, informed consent form and CRF development to ensure feasibility of biological sampling and alignment with ICH/GCP, sample testing plans and data collection and reconciliationDevelop and implement a global strategy for standardization of clinical sample management for inspection readiness including development of SOPs for practices across clinical programsAccountable for training, managing, and providing oversight of Biomarker Operations team and driving the overall biomarker operational strategy for the pipelineWHO YOU ARE AND WHAT YOU BRING:
Life Science Degree or Higher At least 7+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment3+ years Clinical or biological laboratory experience with involvement in the processing or analysis of biological samplesClinical development experience working on a crossfunctional team responsible for the execution of clinical studies, oncology preferredCompetent in application of standard business procedures (standard operating procedures, International Conference on Harmonization , Global Regulations, Ethics and Compliance)Project management skills and knowledge of project management tools
WHO WE ARE AND WHAT WE OFFER:
The expected salary range for this position is $168,500 to $246,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch each day in the office.
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.
Vir Biotechnology ("Vir") is an equal opportunity employer. All employment decisions at Vir are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to race, color, religion, sex (including pregnancy), gender, gender identity, gender expression, sexual orientation, age, parental status, marital status, national origin, ancestry, disability, medical condition, genetic information (including family medical history), political affiliation, military service or any other legally protected characteristic.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir also strongly commits to providing employees with a work environment free of unlawful discrimination or harassment.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir 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, Inc., participates in E-Verify.
Candidate Privacy Notice
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results.
THE OPPORTUNITY:
Supporting the development portfolio, the Associate Director, Biosample Operations will planall project management and operational activities required to operationalize the VIR biomarker strategies (PK, ADA, PD, Exploratory Biomarker and CDx) for programs across the VIR portfolio. You will ensure continuity and integrity across projects, coordinate assay development and implementation activities and acts as the primarycontact for projects requiring biomarker and diagnostic activities including collection, delivery and assay testing of all biosamples within one or more clinical projects or clinical studies. You will also be responsible for any biomarker and CDx sub-team meeting management, dashboards, following up on actions, organizing meetings and tracking biomarker deliverables. In addition to the core biomarker activities, you will be involved in some clinical operation activities for clinical site management in the context of biomarker sample collection education and compliance at clinical sites.
This role will report to the VP, Clinical Operations Oncology
This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.
WHAT YOU'LL DO:
Drive the implementation and execution of the clinical biomarker and diagnostic plans for therapeutic programs in early and late stage clinical development across therapeutic areasAccountable for project management and appropriate planning of related biomarker analysis and samples management costs within a project(s) or clinical studiesPlan and implement the PK and biomarker and diagnostics biosamples collection within a project(s) or clinical study including definition of the appropriate material, instructions, lab manual development Kit development, database set up, etcEnsure the timely and efficient delivery of all biosample, including scheduling analyses with relevant vendors, sample processing and shipment, analysis, data delivery and final sample disposition.Serve as vendor operations lead with central lab and other ancillary labs and will oversee sample shipment and coordination of sample analyses, data transfers and sample reconciliationBe the first contact for PK biomarker and diagnostics biosamples operational questions and issues within a project(s) and coordinates with internal and external partnersProvide guidance during protocol, informed consent form and CRF development to ensure feasibility of biological sampling and alignment with ICH/GCP, sample testing plans and data collection and reconciliationDevelop and implement a global strategy for standardization of clinical sample management for inspection readiness including development of SOPs for practices across clinical programsAccountable for training, managing, and providing oversight of Biomarker Operations team and driving the overall biomarker operational strategy for the pipelineWHO YOU ARE AND WHAT YOU BRING:
Life Science Degree or Higher At least 7+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment3+ years Clinical or biological laboratory experience with involvement in the processing or analysis of biological samplesClinical development experience working on a crossfunctional team responsible for the execution of clinical studies, oncology preferredCompetent in application of standard business procedures (standard operating procedures, International Conference on Harmonization , Global Regulations, Ethics and Compliance)Project management skills and knowledge of project management tools
WHO WE ARE AND WHAT WE OFFER:
The expected salary range for this position is $168,500 to $246,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch each day in the office.
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.
Vir Biotechnology ("Vir") is an equal opportunity employer. All employment decisions at Vir are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to race, color, religion, sex (including pregnancy), gender, gender identity, gender expression, sexual orientation, age, parental status, marital status, national origin, ancestry, disability, medical condition, genetic information (including family medical history), political affiliation, military service or any other legally protected characteristic.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir also strongly commits to providing employees with a work environment free of unlawful discrimination or harassment.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir 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, Inc., participates in E-Verify.
Candidate Privacy Notice