Clinical Safety Director

At Big Health, our mission is to help millions back to good mental health. Our digital therapeutics - Daylight? for worry and anxiety and Sleepio? for poor sleep - are fully automated cognitive and behavioral programs that are as scalable and clinically validated as drugs. Our software combines the intimacy of the human voice, engaging animation, and clinically rigorous techniques to help people overcome their mental health challenges.

As our Clinical Safety Director, you will be accountable for ensuring the safety of our digital therapeutic users. You will drive the refinement of our existing clinical safety strategy to ensure that our safety policies are aligned with the highest standards for clinical and industry best practices. As we expand to new markets and develop additional care pathways and strategies, you will expand our clinical safety strategies and develop new protocols to ensure user safety. You will work closely with our Quality and Regulatory team, providing clinical input to ensure that our safety policies surpass the bar for international and regulatory body requirements. You will also work closely with our Product Development Team and our Clinical, Research, and Medical Affairs Team. You will report to Dr. Jenna Carl, Big Health's Chief Medical Officer.

This post will be full-time, or near full-time and based in the United States.

Big Health is a remote-first company - we are headquartered in San Francisco and have a distributed team across the US and the UK. This role can be based anywhere in the US. Join us!

To learn more about working at Big Health, please go to Built In and Glassdoor.

What you'll do:

• Refine, implement, and manage a robust and state-of-the-art clinical safety strategy for our digital therapeutics that aligns with the highest standards for clinical and industry best practices.
• Ensure the safety of our users (e.g., developing and implementing response plans; developing and implementing protocols for escalation of care; being "on call" if a user is in an acute crisis).
• Author, review, and maintain all relevant clinical governance documentation (e.g, our policies for determining user risk and escalation procedures, documentation of clinical safety events and actions/responses taken).
• Work closely with our Quality and Regulatory team, providing clinical safety input to ensure our safety processes are consistent with regulatory requirements and standards.
• Ensure compliance with mandatory reporting requirements to local, state, federal, and international agencies as they relate to user safety.
• Identify and track safety metrics to demonstrate the quality and effectiveness of safety processes and protocols.
• Develop new clinical safety training materials and implement training procedures for current and future Big Health employees.
• Work closely with our User Happiness team, audit User Happiness communications, and provide feedback as appropriate.

What you bring:

• Medical Doctor (MD or equivalent) with mental health training and experience (e.g., psychiatry, family medicine, primary care) that is currently licensed/registered with a professional body
• A minimum of 6 years of related experience as defined by: 3+ years of clinical practice experience (e.g, residency program, private practice, internship and post-doc programs) and 3+ years experience in patient safety within the consumer, pharmaceutical, and/or medical device sectors
• Prior leadership responsibility with a proven track record of implementing change and patient safety improvements in a complex environment
• A strong understanding of safety assessment and response protocols, mandated reporting, and escalation procedures
• Must have excellent verbal and written communication skills and attention to detail
• Past experience with safety related to digital health tools (digital therapeutics, telehealth, EHRs, etc) is extremely helpful, though not required

Life at Big Health:

• Be part of a team that includes clinical psychologists, software engineers, business leaders and even a former professional magician [shh... it's a secret].
• Surround yourself with the smartest, most enthusiastic and dedicated people you'll ever meet, but who listen well, learn from their mistakes and when things go wrong, generously pull together to help each other out
• Check out our values - they're a living, breathing part of our culture
• Enjoy benefits including a generous vacation policy, professional development fund, flexible working locations and more.
• Competitive salary packages including stock options.

Because we are on a mission to bring millions back to good mental health, we believe it's essential to reflect the diversity of those we intend to serve. We're an equal opportunity employer dedicated to building a culturally and experientially diverse team that leads with empathy and respect.

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. Big Health participates in E-Verify and will provide the federal government with Form I-9 information from all new employees to confirm that they are authorized to work in the U.S. Big Health does not use E-Verify to pre-screen applicants.