Senior Director/Director of Regulatory Affairs

San Francisco
Clinical
Full time
At Big Health, our purpose is to help millions back to good mental health. We do this by creating what we call, “Digital Medicine”. Our programs are highly personalized, automated behavioral therapy programs, backed by gold standard clinical evidence, that can offer a true alternative to prescribed medication. 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 cognitive and behavioral 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.

We are now recruiting a Sr Director/Director of Regulatory Affairs to take the lead in designing the regulatory strategy for our mobile medical apps, and developing and directing a regulatory affairs function to support the associated quality and regulatory 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 if desired.

Primary responsibilities are 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 [Chief Medical Officer]) and will work closely with Dickon Waterfield (Chief Commercial Officer), Jenna Carl (Medical Director), and Kelvin Kwong (VP of Product).

As a Sr. Director or Regulatory Affairs at Big Health, you will:

    • Develop all aspects of Big Health’s global regulatory strategy with the objective of harnessing digital medicine's potential to reach millions efficiently.
    • Develop a regulatory affairs function, including building internal and external capacities for efficient operations, and overseeing the adoption and maintenance of relevant working practices and procedures.
    • Work closely with the CEO, CMO, and CCO to provide insights on implications, risks and opportunities associated with different regulation pathways.
    • Work closely with the Medical Director and VP of Product to provide clinical and product guidance in relation to regulatory considerations; and work with cross-functional teams to define contributions to regulatory submissions.
    • Maintain knowledge of the global regulatory environment, regulations and guidelines.
    • Identify and communicate information about potential regulatory issues and propose risk evaluations and mitigation strategies.
    • Act as Big Health’s primary liaison to regulatory agencies (e.g., FDA, MHRA) and take responsibility for all agency filing and compliance processes.
    • Oversee and manage all of Big Health’s quality and regulatory activities to ensure that they are conducted in full compliance with applicable regulations and at the highest level of ethical standards.
    • 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.

To be successful in this role you will need:

    • Advanced degree in a relevant scientific or clinical area is preferred (e.g., PhD, MD).
    • 10 years experience in the pharmaceutical, biotechnology, or health industry, including five years in a leadership role pertaining to regulatory affairs.
    • Experience in preparing FDA and international regulatory filings, interacting with regulatory bodies, and obtaining successful FDA regulatory clearance for a mobile medical app or other SaMD.
    • Knowledge of US and UK/EU regulatory and ICH/GCP guidelines and how they are applied to SaMD/mobile medical apps.
    • Track record of leading the development and implementation of complex regulatory strategies and associated reimbursement pathways.
    • Effective in a team-based, collaborative environment with excellent written and interpersonal communication skills.

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
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.