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.
Vir Biotechnology is seeking an experienced Director, Toxicology to lead nonclinical safety strategies across our infectious disease and oncology portfolio. In this role, you will provide scientific leadership for toxicology and safety assessment activities from candidate selection through clinical development, working closely with cross-functional teams and external partners to advance programs efficiently and effectively.
You will contribute to study design, data interpretation, regulatory submissions (IND and NDA/BLA), and risk assessment, while driving innovative approaches to support successful drug development. This position reports to the VP of Translational Development.
This role is located in our San Francisco headquarters with an expectation of at least 3 days per week in the office.
WHAT YOU'LL DO- Develop and execute the nonclinical toxicology strategy across multiple development programs from candidate selection through registration and life cycle management
- Oversee nonclinical safety studies (GLP and non-GLP) in compliance with regulations and company SOPs
- Accountable for the design, review and interpretation of nonclinical toxicology study reports and report finalization consistent with the necessary global regulatory and compliance requirements
- Strong knowledge of GLP regulations and regulatory guidelines for testing biologics is required
- Leads development and review of regulatory documents (CTAs, IMPDs, INDs, BLAs, etc) and interact with regulatory authorities as needed
- Partner with and provide subject matter expertise to key internal stakeholders (e.g. Regulatory, Clinical, CMC) and their external co-collaborators to ensure proper integration of nonclinical activities into overall development plans
- Contribute to the departmental procedures such as SOPs and templates
- Maintains a current understanding of significant literature and methodology, as well as the scientific literature related to Vir Bio’s pipeline and R&D projects
- Works as part of a multidisciplinary team to bring discovery candidates into development and through licensure
- Generates literature reviews
- DVM or PhD in Pharmacology/Toxicology or Biomedical Sciences
- DABT Certification strongly preferred
- 12+ years of relevant experience in industry conducting biologics and pharmaceutical research and development, and preferably with oncology and infectious disease biologics specialization
- Working knowledge of FDA, EMA, and ICH guidance including GLP regulations
- Experience in authoring regulatory submissions, e.g. INDs, BLA and preparing science-based responses to regulatory inquiries
- Functional understanding of QA, regulatory, and clinical responsibilities to guide key nonclinical activities, setting up drug candidates for success at all stages of development
- Excellent scientific written and oral communication skills are required
- Ability to work highly effectively and collaboratively with multiple departments and on cross-functional project teams
- Willingness to learn new areas of expertise
- Outstanding attention to detail working in a time sensitive, high paced environment
- Innate flexibility to work in a rapidly growing matrixed environment. Excellent interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines
The expected salary range for this position is $203,500 to $284,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir Biotechnology'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 Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, 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.
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.
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Skills Required
- DVM or PhD in Pharmacology/Toxicology or Biomedical Sciences
- DABT Certification
- 12+ years relevant industry experience in biologics/pharmaceutical R&D, preferably oncology and infectious disease
- Working knowledge of FDA, EMA, and ICH guidance including GLP regulations
- Experience authoring regulatory submissions (INDs, BLAs) and responding to regulatory inquiries
- Functional understanding of QA, regulatory, and clinical roles to guide nonclinical activities
- Excellent scientific written and oral communication skills
- Ability to work effectively and collaboratively on cross-functional teams
- Outstanding attention to detail and ability to work in a time-sensitive, high-paced environment
- Innate flexibility, strong interpersonal skills, ability to lead and drive consensus in matrixed environment
- Willingness to learn new areas of expertise
- Work in San Francisco office at least 3 days per week
- Authorization to work in the U.S. without visa sponsorship
What We Do
Vir Biotechnology, Inc. (in Europe, Humabs BioMed, https://bit.ly/46lQGN2) is an immunology company focused on powering the immune system to address unmet patient needs in infectious disease and beyond. Our powerful R&D engine combines our proprietary monoclonal antibody (mAb) platform with machine learning and artificial intelligence-enhanced capabilities, enabling us to engineer our rich database of human antibodies and deliver transformative medicines for diseases with significant global burden. Our current pipeline consists of multiple clinical candidates targeting hepatitis B and hepatitis delta viruses and human immunodeficiency virus, including a potential functional cure for chronic hepatitis B and treatment for chronic hepatitis delta. Our portfolio of broad, potent investigational monoclonal antibodies also targets influenza A and B viruses, COVID-19, respiratory syncytial virus/human metapneumovirus and human papillomavirus, and our investigational T cell vaccine aims to prevent HIV. Explore our full pipeline: https://bit.ly/3tr7FPm We collaborate with some of the world’s leaders in industry as well as government agencies and non-profit organizations enabling us to rapidly advance cutting-edge scientific discoveries and innovative technologies with the potential to benefit people around the world. We are proud to have been ranked the fastest-growing company in North America on the 2022 Deloitte Technology Fast 500™. Join us as we pursue our mission to transform lives. It has come to our attention that there have been various recruitment scams targeting job seekers on LinkedIn. Vir Biotechnology, Inc. is committed to your privacy and will never request sensitive personal information including banking details through email, text message, social media or video software platforms. We also will never request a financial commitment from a candidate as part of the application process. Learn more about Vir’s recruiting process: https://bit.ly/461EgJN
