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Vir Biotechnology

Develops monoclonal antibodies for infectious diseases

Senior Vice President, Regulatory Affairs

Full-TimePosted on 10/14/2026
$350k - $400k/yr+ Bonus + Equity
Expert
PharmD, PhD, MD
San Francisco, CA, USA
HybridAt least three days per week in the San Francisco office.
Biology & BiotechRegulatory & Quality (Life Sciences)
No H1B Sponsorship

About the job

Requirements
  • Advanced scientific or medical degree (PhD, PharmD, MD, or equivalent) preferred.
  • At least 15 years of Regulatory Affairs experience with a proven track record of leadership and organizational impact across the biotechnology and/or pharmaceutical industry.
  • Extensive experience developing and executing global regulatory strategies across all stages of development, from preclinical development through approval and lifecycle management.
  • Proven track record of leading major regulatory submissions and approvals, including direct experience with BLA submissions, biologics development, and global registration strategies.
  • Significant experience leading regulatory interactions with the FDA, EMA, and other global Health Authorities.
  • Demonstrated ability to influence executive-level decisions, balance risk, and guide complex development programs.
  • Experience building, developing, and leading high-performing global teams and organizations.
  • Exceptional communication, relationship-building, and stakeholder management skills.
Responsibilities
  • Lead and evolve Vir Bio's global Regulatory Affairs organization, setting the vision, strategy, structure, and capabilities needed to support the company's current and future portfolio.
  • Serve as the company's most senior regulatory leader, providing strategic counsel to executive leadership and influencing key portfolio, development, and business decisions.
  • Define and execute global regulatory strategies across all stages of development, balancing the immediate needs of a late-stage registration program with the differentiated regulatory pathways required for innovative early-stage programs.
  • Lead and oversee regulatory interactions with global Health Authorities, building productive relationships, shaping regulatory pathways, and driving successful outcomes across key markets.
  • Lead filing readiness, cross-functional submission planning and execution, Health Authority review, approval activities, and post-marketing commitments for major regulatory applications, ensuring continuity, clear accountability, and alignment with corporate objectives and development priorities.
  • Assess regulatory risks, opportunities, and emerging trends to inform development strategy, portfolio decisions, and long-term business planning.
  • Partner across the organization to ensure regulatory considerations are integrated into development plans, portfolio strategy, and corporate objectives.
  • Build, develop, and retain a high-performing Regulatory Affairs organization while fostering a culture of collaboration, accountability, innovation, and continuous development.
  • Represent Regulatory Affairs on executive governance, portfolio review, and development leadership forums, serving as a trusted advisor and strategic thought partner to senior leadership.
  • Drive operational excellence across the regulatory function, ensuring effective planning, prioritization, resource allocation, and execution in support of company objectives.
  • Champion Vir Bio’s external presence within the regulatory and biotechnology communities through engagement with Health Authorities, industry organizations, professional societies, and key external stakeholders.

About the company

V

Vir Biotechnology

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Vir Biotechnology develops treatments for infectious diseases like hepatitis B, HIV, and influenza by engineering monoclonal antibodies and T cell vaccines. The company uses a proprietary platform enhanced by machine learning and artificial intelligence to identify and optimize human antibodies that can neutralize viruses or stimulate the immune system. Unlike many competitors, Vir integrates these AI capabilities with a broad collaborative network of government and industry partners to rapidly scale its scientific discoveries. Its primary goal is to provide functional cures and preventative medicines for diseases that carry a significant global health burden.

Company Size

201-500

Company Stage

IPO

Headquarters

San Francisco, California

Founded

2016

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Simplify's Take

What believers are saying

  • Q2 2026 cash reached $1.01 billion, funding operations into second-half 2028.
  • Vir completed enrollment across all three ECLIPSE studies; Q1 2027 readouts follow.
  • Astellas delivered $240 million upfront plus $75 million equity, de-risking development costs.

What critics are saying

  • CMO Mark Eisner left April 24, 2026, and CFO Jason O'Byrne leaves August 3.
  • ECLIPSE 1 readout in Q4 2026 is binary; failure crushes the HDV franchise.
  • Vir's oncology pivot depends on VIR-5500 success and Astellas; setbacks erase its future.

What makes Vir Biotechnology unique

  • Vir owns the only registrational hepatitis delta package, with ECLIPSE 1 data due Q4 2026.
  • Astellas validated PRO-XTEN VIR-5500, paying $315 million and sharing U.S. profits.
  • Vir combines infectious-disease immunology with masked T-cell engagers, spanning HDV and prostate cancer.

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Benefits

  • Comprehensive healthcare coverage
  • Employer matched 401(k)
  • Employee stock purchase plan
  • Childcare assistance
  • Tuition reimbursement

Growth & Insights and Company News

Headcount

6 month growth

1%

1 year growth

0%

2 year growth

-1%
TradingView
Oct 16th, 2026
Stocktwits biotech dealmaker: Gilead, AstraZeneca and Roche chase pipeline expansion over buyouts.

Stocktwits biotech dealmaker: Gilead, AstraZeneca and Roche chase pipeline expansion over buyouts. Key points: * Gilead Sciences partnered with Vir Biotechnology on Wednesday to discover and develop three drugs aimed at solid tumors. * AstraZeneca signed an up-to-$1.5 billion AI collaboration with insitro for MASH and cardiomyopathies. * Roche licensed Rona's drug candidate, and Zealand Pharma teamed with Generate on AI-designed proteins for differentiated obesity approaches. Large pharmaceutical companies including Gilead Sciences, Roche and AstraZeneca spent this week securing access to discovery technologies and experimental candidates that address clear biological gaps, instead of large-scale acquisitions of rival firms or approved products. Obesity and cancer remained the clear focal points, with several of the week's biggest partnerships aimed at differentiated weight-loss mechanisms or new solid-tumor approaches. Gilead Partners With Vir For New Cancer Drug Candidates Gilead Sciences (GILD) partnered with Vir Biotechnology (VIR) on Wednesday to discover and develop three drugs aimed at solid tumors. Vir will handle early discovery, design, and optimization using its AI-enabled protein engineering tools and PRO-XTEN masking technology. Gilead receives exclusive rights to nominate candidates and will lead subsequent development, manufacturing, and commercialization. Vir is eligible for $90 million upfront - $65 million in cash plus a $25 million equity investment at a premium - plus up to $45 million in near-term preclinical milestones and as much as $1.74 billion in later development, regulatory, and commercial payments, along with tiered royalties. The agreement marks Vir's second major partnership around its masking platform this year after a previous deal with Astellas and adds to Gilead's attempts to advance its cancer offerings besides its blockbuster drug Trodelvy. AstraZeneca Taps Insitro's AI Platform AstraZeneca (AZN) signed a worldwide exclusive research collaboration with privately held AI therapeutics company insitro focused on metabolic dysfunction-associated steatohepatitis (MASH) and cardiomyopathies. Insitro will apply its Virtual Human platform, which combines human and cellular data with AI, to identify causal disease biology and advance AstraZeneca-nominated targets through discovery to the development-candidate stage. AstraZeneca will lead clinical development, regulatory work, and commercialization. Insitro will receive $40 million upfront and is eligible for up to approximately $1.46 billion in discovery, development, and commercial milestones, plus single-digit royalties on potential sales. Roche, Zealand Pharma Add Differentiated Obesity Approaches Roche secured exclusive worldwide rights to Rona Therapeutics' investigational drug candidate which targets a protein predominantly expressed in fat tissues. The drug candidate is designed to selectively reduce visceral and ectopic fat while preserving lean mass - an attractive complement to currently popular obesity drug classes like GLP-1. Rona is eligible for up to $100 million in upfront and near-term payments, up to $1.06 billion in additional milestones, and tiered royalties. Separately, Zealand Pharma entered a collaboration with Generate Biomedicines (GENB) to design multispecific protein therapeutics for obesity and other metabolic diseases using Generate's generative AI platform. Generate will lead research through lead-candidate selection for two initial programs, with an option for a third; Zealand will handle clinical development, regulatory submissions, and commercialization. Generate receives $30 million upfront, up to $35 million in early preclinical milestones, and nearly $1.2 billion in total potential milestones, plus royalties. Pfizer, Galderma Make Platform And Commercial Moves Pfizer (PFE) partnered with privately-held Enodia Therapeutics on a research collaboration and license for compounds intended to block disease-driving proteins at the point of synthesis. The potential value exceeds $500 million, including an upfront payment, milestones, and royalties; Enodia will run discovery against multiple targets while Pfizer takes over later development and commercialization. How Did Retail Traders React? On Stocktwits, retail sentiment around SPDR S&P Biotech ETF (XBI) fell from bullish to neutral territory over the past 24 hours, while message volume stayed at normal levels. XBI has fallen 4% over the past week as part of a broader biotech pullback that began after its mid-August peak near $170, but it is up 22.5% year-to-date.

PharmaVoice
Oct 15th, 2026
Gilead and Vir forge $1.9bn pact to develop next-gen T-cell engagers.

Gilead and Vir forge $1.9bn pact to develop next-gen T-cell engagers. Oct 15, 2026, 1:30 PM Translate article text Choose a language and wait for the translated text. This deal sees Gilead double down on TCEs, following its first bet on the modality through its buyout of autoimmune-focused Ouro Medicines.

Ochre Digi Media Pvt. Ltd.
Oct 15th, 2026
Vir Biotechnology enters into collaboration with Gilead Sciences to develop T-cell engagers for solid tumours.

Vir Biotechnology enters into collaboration with Gilead Sciences to develop T-cell engagers for solid tumours. Thursday, October 15, 2026 Vir Biotechnology has entered into a collaboration and licensing agreement with Gilead Sciences to discover and develop three novel T-cell engager (TCE) candidates for the treatment of solid tumours. T-cell engagers are designed to direct T cells, a type of immune cell, towards cancer cells and help destroy them. Although these treatments have become an important option for certain blood cancers, their use against solid tumours has been limited by the risk of toxicity. Under the agreement, Vir Biotechnology will use its expertise in TCE discovery and protein engineering, along with its proprietary dAIsY(TM) platform and PRO-XTEN(R) masking technology, to design and optimise the candidates. The treatments will target selected antigens associated with solid tumours, with the aim of improving anti-tumour activity while reducing the risk of toxicity. Vir Biotechnology will lead the discovery, design and optimisation of the three candidates. Gilead Sciences will hold exclusive rights to select candidates for further development and will be responsible for their subsequent development, manufacturing and commercialisation. The agreement includes upfront and near-term preclinical milestone payments of up to US$135 million for Vir Biotechnology. This comprises US$90 million in upfront consideration, including US$65 million in cash and a US$25 million equity investment at a 30% premium, as well as up to US$45 million in potential preclinical milestone payments. Vir Biotechnology may also receive up to US$1.74 billion in additional development, regulatory and commercial milestone payments. The agreement includes tiered royalties ranging from high single-digit to low double-digit percentages of net sales. Vir Biotechnology's PRO-XTEN(R) technology is designed to keep T-cell engagers inactive until they reach the tumour microenvironment. Enzymes found in this environment remove the masking component, activating the treatment and allowing T cells to attack cancer cells. The technology is also intended to extend the medicines' time in the body, potentially reduce toxicity and support less frequent dosing. Through this collaboration, the companies aim to develop new immunotherapies for solid tumours, where treatment options remain limited. The agreement also combines Vir Biotechnology's discovery and engineering capabilities with Gilead Sciences' oncology development and commercialisation expertise.

Pharmaceutical Executive
Oct 14th, 2026
Vir Biotechnology enters R&D collaboration with Gilead for three novel PRO-XTEN dual masked t-cell engagers.

Vir Biotechnology enters R&D collaboration with Gilead for three novel PRO-XTEN dual masked t-cell engagers. Gilead and Vir Biotechnology Enter a $1.87 billion collaboration to discover three PRO-XTEN dual-masked T-cell engagers aimed at solid tumors. Vir Biotechnology, entered a collaboration and license agreement with Gilead to discover and engineer three novel PRO-XTEN dual-masked T-cell engager development candidates targeting selected solid tumor-associated antigens. As part of the collaboration, Gilead will hold an exclusive license to develop and commercialize the resulting therapies, with Vir eligible to receive up to $1.87 billion in combined near-term and milestone payments.[1] Vir will be responsible for discovery, design and optimization of the three T-cell engager candidates, applying its proprietary Daisy platform for rapid, multiparameter optimization alongside its universal PRO-XTEN masking technology.[1] Gilead is granted an exclusive license to nominate and advance candidates generated through the collaboration and is expected to take on subsequent development, manufacturing and commercialization activities. What are the details of the deal? Vir Biotechnology is eligible to receive up to $135 million in total upfront and near-term preclinical milestone payments, which breaks down into $90 million in upfront consideration, consisting of $65 million in cash and a $25 million equity investment priced at a 30% premium, plus up to $45 million in potential near-term preclinical milestones.[1] Beyond that initial tranche, Vir has the potential to receive up to $1.74 billion in further development, regulatory and commercial milestone payments, along with tiered royalties on net sales ranging from high single digits to low double digits.[1] How does the masking technology work? T-cell engagers are designed to direct the immune system, particularly T-cells, to destroy cancer cells. While the modality has become an important treatment option in blood cancers, its use in solid tumors has historically been limited by toxicity. Vir's PRO-XTEN masking technology is built to address that limitation. It is designed to extend the half-life of the molecule and keep T-cell engagers inactive, or masked, until they reach the tumor microenvironment.[2] There, tumor-specific proteases cleave off the mask and activate the T-cell engager, triggering T-cell killing of cancer cells. By extending half-life and confining activity to the tumor microenvironment, the company says the technology could limit toxicity, widen the therapeutic index of T-cell engagers, and potentially enable less frequent dosing regimens.[2] Putnam's CEO Matt Riordan with Pharmaceutical Executive about the importance of innovation, specifically highlighting how it's playing out in the oncology space. "Solid tumors represent the vast majority of cancer cases worldwide, and if CAR-T therapies can be successfully translated, they could redefine the standard of care for millions of patients." Why does this partnership matter for both companies? For Vir, the agreement adds external validation to its discovery engine while preserving the company's own clinical oncology ambitions. "We believe T-cell engagers have a powerful role to play in the future of immunotherapy to treat cancer," said Marianne De Backer, president and chief executive officer of Vir Biotechnology. "This collaboration with Gilead provides an opportunity to generate multiple differentiated candidates aimed at difficult-to-address solid tumors and to expand the potential impact of our science, while also advancing our own clinical oncology portfolio. This transaction provides further external validation of Vir Biotechnology's integrated discovery capabilities and the broad potential of the PRO-XTEN platform." For Gilead, the collaboration extends an oncology pipeline that already includes substantial development infrastructure. "We look forward to combining Gilead's established and growing oncology capabilities, including our extensive development expertise and focus on next-generation immunotherapies, with Vir Biotechnology's innovative discovery capabilities," said Flavius Martin, executive vice president, research, Gilead Sciences. "Together with Vir Biotechnology, we seek to bring meaningful innovative therapeutics to patients."

MarketScreener
Oct 14th, 2026
Vir, Gilead team up on solid tumor cancer therapies in up to $1.9 billion deal.

Vir, Gilead team up on solid tumor cancer therapies in up to $1.9 billion deal. Published on 10/14/2026 at 09:22 am EDT or by email Gilead Sciences, Inc. specializes in the development, manufacturing and marketing of therapeutic products. Net sales break down by source of income as follows: - sale of drugs (98.2%): for the treatment of HIV (71.8% of net sales), oncology diseases (11.2%), hepatitis B virus (11.1%), Ebola virus (3.2%) and other (2.7%; primarily cytomegalovirus retinitis, and advanced Kaposi sarcoma resulting from HIV); - other (1.8%): especially royalties and revenue from research and development services and from subcontracted production of therapeutic products. Net sales are distributed geographically as follows: the United States (70.9%), Europe (17.2%) and other (11.9%). Mean consensus Number of Analysts Last Close Price 147.92 USD Average target price 159.62 USD Spread / Average Target