Head of Regulatory Affairs

Who We Are

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Vial is a hyper-scalable biotech company advancing programs into the clinic by leveraging dramatically cheaper trials and computationally designed therapeutics.

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Our mission is to reimagine drug development in order to cure all human diseases. We have assembled a talented team of clinical operators, chemists, and innovative thinkers to achieve this vision.

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Vial is based in San Francisco, California, and was founded by Simon Burns in October 2020. Since our founding, we have grown rapidly to a team of 100+ employees with over $100 million in funding from leading investors including General Catalyst, Box Group, and Byers Capital.

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Vial is rebuilding the infrastructure to advance research. By deploying technology at every step, we are creating a more efficient future for drug discovery.

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Position Overview

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In the Head of Regulatory Affairs role (title dependent on experience), you will develop and execute regulatory strategies that accelerate the development of lower-cost drug discovery and cures while ensuring Vial’s compliance with global requirements. Reporting to the Chief Corporate Affairs Officer, you will spearhead Vial’s regulatory goals, and help the company navigate evolving regulatory landscapes. You will directly be responsible for positioning the company as a leader in an efficient, equitable, and globally competitive U.S. drug development ecosystem.

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What You’ll Do

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• Strategic Regulatory Leadership  
• Design and oversee regulatory strategies, optimizing the approval process for drug candidates and clinical trials— aimed at reducing overall drug development costs and enabling innovative strategies.  
• Monitor and respond to changes in regulatory policies, ensuring alignment with Vial’s long-term objective of bringing more affordable cures to market.  
• Align and add-value to strategy and operations teams.
• Establishing New Capacities  
• Implement robust internal systems and SOPs for managing regulatory filings, communications, and inspections.  
• Lead cross-functional teams to support innovative trial designs that foster efficiency without compromising safety or quality.
• Global Regulatory Agency Engagement  
• Act as Vial’s liaison to major regulatory bodies, proactively collaborating with agencies on strategies that speed up drug approval timelines.  
• Oversee the preparation of essential regulatory documents, focusing on operational excellence and compliance.
• Team Development & Leadership  
• Build, coach, and mentor a high-performing regulatory team that can adapt to evolving industry demands.  
• Champion a culture of innovation and collaboration, aligning regulatory best practices with Vial’s mission and growth trajectory.

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What You’ll Bring

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• Advanced degree in Life Sciences or related field (Ph.D., PharmD, MD, or Master’s) preferred.  
• Preferred — Extensive experience in regulatory affairs within pharma, biotech, or CRO settings  
• Including in-house, as a consultant, or in a highly transferrable role like a Congressional Committee staffer.  
• Proven record of streamlining regulatory processes to reduce time and cost in drug development.  
• Ability to excel in a startup environment, establishing new structures and strategies quickly.  
• Strong communication, leadership, and strategic thinking abilities.

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Why You’ll Love Working At Vial

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• Innate curiosity.  

  At our core, we embody an insatiable curiosity. Our journey into the realm of clinical trials was ignited by a firsthand understanding of the challenges involved. This innate curiosity drives us to constantly innovate, seek fresh ideas, and bring our vision of reimagining clinical trials to life.

• Fostering autonomy.  

  Autonomy is our guiding principle. We firmly believe that when team members are entrusted with autonomy, they unleash their true potential. Our culture fosters an environment where each individual takes ownership of their domain, empowering them to make a profound impact.

• The pursuit of mastery.  

  We are dedicated to cultivating mastery. We understand the value of honing expertise in a craft. The pursuit of mastery, coupled with a deep sense of pride in one's workmanship, fuels our unwavering commitment to tackle intricate challenges. At Vial, we foster a culture of highly autonomous professionals, each an expert in their field, collaborating on an immensely demanding endeavor together.

• Move fast, stay humble.  

  Our strength lies in agility and humility. We firmly believe that intellectual honesty and a nimble mindset are the pillars of success. By staying adaptable and open-minded to all solutions, we tackle obstacles head-on, remaining humble in the face of adversity. This enables us to surmount the hurdles that confront us at every twist and turn.

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Benefits

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• Competitive Equity Compensation  
• Health, Dental, and Vision Benefits  
• Retirement Savings Plan with Company Matching after 90 Days of Employment  
• One time, Remote Office Setup Stipend  
• Paid Parental Leave  
• Remote-First, Flexible Work Schedule  
• Observed US & Canada Holidays  
• Unlimited Vacation

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We prioritize candidate safety. Please be aware that official communication will only be sent from '@vial.com' or '@tryvial.careers' addresses. Vial is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.