Vice President of Regulatory Affairs and Quality

San Francisco
Clinical
Full time
At Big Health, our purpose is to help millions back to good mental health. We do this by creating Digital Therapeutics: fully automated and highly personalized cognitive behavioral therapy (CBT) programs for mental health. In addition to being backed by an extensive portfolio of clinical research, our programs follow our core product philosophy of using “entertainment as medicine” as the way to engage individuals and in turn help them to acquire the necessary skills to overcome their troubles, be it poor sleep or worry and anxiety.

Our first program, Sleepio, has been the subject of extensive research, including eight randomized controlled trials (RCTs), that indicates its effects improving sleep are on par with in-person CBT for insomnia. Sleepio is recognized by RAND Corporation, Nature, Ranked, and The King’s Fund as the best evidenced App in its category. Sleepio is currently available to over 12 million people across 60+ countries.

We are now recruiting a VP of Regulatory Affairs & Quality to take the lead in designing our regulatory strategy for a clinical grade product line, and developing a regulatory affairs and quality function to support this new line of work. This is a full-time leadership role touching all of Big Health’s company-wide objectives.

This post will be full-time and based in San Francisco with flexibility for remote working.

Primary responsibilities are ensuring excellence in the development and implementation of strategic regulatory objectives in service of the goal of helping millions back to good mental health. This post will report directly to one of the co-founders (Peter Hames [CEO] or Colin Espie [CMO]) and will work closely with Dickon Waterfield (Chief Commercial Officer), Jenna Carl (Medical Director), and Kelvin Kwong (VP of Product).

Specific Responsibilities will Include:

    • Develop all aspects of Big Health’s global regulatory strategy with the objective of harnessing digital medicine's potential to reach millions efficiently.
    • Design, implement, and oversee a quality management system to support the ongoing development of software-based clinical grade digital therapeutics
    • Develop and manage an internal regulatory affairs and quality function, including developing the internal and/or external resources needed for achieving regulatory and quality objectives.
    • Maintain knowledge of the global competitive landscape, regulatory environment, regulations and guidelines; providing ongoing appraisal of strategic regulatory opportunities.
    • Work as part of Big Health’s senior team to implement the company’s strategic objectives, influencing both commercial and product strategy.
    • Act as Big Health’s primary liaison to regulatory agencies (e.g., FDA, MHRA) and take responsibility for all agency filing and compliance processes.
    • Work closely with clinical and product teams to define contributions to regulatory submissions and to develop an efficient QMS that aligns with current working practices.
    • Serve as an advocate for Big Health within the digital health industry including serving as company representative to relevant industry groups (e.g., Digital Therapeutics Alliance) and contributing to the development of clinical and quality standards and related thought leadership.
    • Direct and manage regulatory intelligence and policy efforts to best impact Big Health; including developing necessary relationships and foster influence and innovation at the agency level.

Requirements:

    • Advanced degree in a relevant scientific or clinical area is preferred.
    • 10 years experience in the pharmaceutical, biotechnology, or health industry, including five years in a leadership role pertaining to regulatory affairs and quality, including direct experience with SaMD products.
    • Extensive experience in preparing FDA and international regulatory filings, interacting with regulatory bodies, and obtaining successful regulatory clearance.
    • Knowledge of US and UK/EU regulatory and ICH guidelines with regard to mobile medical apps/SaMD.
    • Experience managing a quality function and implementing a QMS for a SaMD product.
    • Effective in a team-based, collaborative environment with excellent written and interpersonal communication skills.
    • This post will be full-time and based in San Francisco with flexibility for remote working.

Life at Big Health:

    • Join a diverse team of all backgrounds, we’re proud to be an equal opportunities employer
    • A clearly structured personal review and professional development program
    • Quarterly happiness survey that we use to ensure we’re creating a healthy and productive workplace for ourselves
    • Fund for spending on team happiness
    • Generous vacation and maternity/paternity policy
    • Comprehensive health benefits
    • Competitive compensation

More about Big Health:

    • We have partnerships with Oxford University, leading health insurers, and multiple universities in the US and around the world.
    • We’re backed by a leading venture capital firms, Index Ventures, Octopus Ventures and Kaiser Permanente Ventures.
    • We’re working with many of the Fortune 500 companies, including the most prominent technology firms, and leading healthcare institutions, Sleepio is already available to over a million people, all paid for by their employer and is being rolled out at scale in the NHS

Working with us:

    • We offer flexibility on where and when you work.
    • We care about what you get done and that's how we'll measure you - it is not about the time you spend sitting at your desk.
Big Health is an Equal Opportunity Employer dedicated to the goal of building a culturally & experientially diverse team. Additionally, we will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.