Regulatory & Compliance Lead

PicnicHealth is revolutionizing how life sciences companies advance medicine while providing immediate value to the patients who power the research. Through direct patient engagement, state of the art machine learning, and scientific expertise, PicnicHealth uniquely curates 100% of consenting patients’ medical records to generate the high quality and clinically-rich evidence that life sciences companies need, at a fraction of the cost of traditional study models. At the same time, we give patients immediate access to their medical records through a patient portal that simplifies participation and drives engagement.  To date we’ve helped tens of thousands of patients securely access their records and proactively contribute to advancing research in diseases that impact their lives. 

Founded in 2014, PicnicHealth partners with 12 of the top 20 biopharma companies and has raised over $100 million in venture capital from investors including Amplify Partners, Felicis Ventures and B Capital Group.

If you are looking to join an award winning, mission-driven, motivated team that is making a real impact across millions of people’s lives, PicnicHealth might just be the place for you. 

The Opportunity

As Regulatory & Compliance lead you’ll lead our efforts in ensuring that our decentralized trials and observational research meet the highest standards of regulatory compliance and quality. In this pivotal role, you will develop and maintain a robust Quality Management System (QMS), shape regulatory strategies, oversee risk management, conduct audits, and validate our technology platform. Your expertise will guide our teams and partners through the evolving regulatory landscape, fostering innovative, fit-for-purpose solutions that align with our commitment to scientific excellence and patient-centered care. 

As the Regulatory & Compliance Lead, you will be responsible for:

• Quality Management System (QMS): Develop, enhance and maintain a robust Quality Management System (QMS) aligned with relevant regulatory requirements for the conduct of decentralized and observational research (FDA, GCP, ICH, etc.).
• Regulatory Strategy & Adherence: Develop and implement a comprehensive strategy for navigating the evolving regulatory landscape for decentralized clinical trials, registries and observational research. Provide structure for how PicnicHealth approaches all regulatory activities for studies, including best practices for protocol development, safety reporting, informed consent, etc.
• Risk Management: Develop and adopt a risk-based approach to monitoring clinical research studies. 
• Audit: Conduct regular audits and inspections of decentralized trial processes and technologies to identify and mitigate potential quality and compliance risks.
• Technology Validation: Oversee the validation of PicnicHealth’s technology platform and adherence to existing regulatory requirements (21CFR11, etc.).
• Educate and Inform: Stay abreast of emerging trends and best practices in decentralized trial regulations and quality management. Be a resource for our internal teams and our customers for how we approach regulatory and quality consistent with existing and new expectations and requirements.
• Innovative Problem Solving: Use your deep understanding of regulatory requirements combined with experience at a fast moving small company to help identify risks, know when to innovate, work collaboratively with diverse stakeholders, and drive to innovative, fit-for-purpose solutions.

You are a strong candidate if you have: 

• Extensive experience (8+ years) in clinical trial regulatory affairs and quality assurance, with a strong track record in helping build and evolve systems in a rapidly growing company .
• In-depth knowledge of global regulatory requirements (GCP, ICH, 21CFR11, FDA guidance, etc.) and quality management principles (e.g., ICH Q9).
• Proven ability to develop and implement effective regulatory and quality strategies for decentralized trials and/or observational research.
• Have led technology validation and compliance programs.
• Excellent leadership and communication skills, with the ability to inspire, motivate, and build consensus across diverse teams.
• A strategic, business-oriented thinker who can bring a keen understanding of risk management and mitigation strategies to weighing quality, regulatory, legal, and business risks.
• A passion for innovation and a commitment to scientific excellence.
• Have experience working in a start-up environment with a focus on both technical and scientific excellence and an entrepreneurial spirit and are seeking a high-growth, fast-paced environment where you can innovate and help build a disruptive business.

We expect all team members to be motivated to be amazing in their roles and, ultimately, to move the PicnicHealth mission forward.

Perks & Benefits @PicnicHealth   

At PicnicHealth you get to solve real problems with real solutions, great tech, and great people. We look to attract and retain exceptional performers through a mission that matters, a culture that allows team members to do their best work and be their real selves, and through competitive compensation and benefits packages aligned to the market and our Core Values.

We’re a remote first company, with teammates spread across the US. We support in-person gatherings, including co-working spaces and multi-day onsites,  to build connections and move forward strategic initiatives. Expect to travel 2-4 times a year.  For our team members in the Bay Area, who prefer to work in person we can offer a hybrid set up to work from the SF office on a flexible schedule.

Target Base Salary Range:  $160K - 190K

The base salary PicnicHealth offers may vary depending upon the ultimate scope and responsibilities of the position and on the candidate’s job-related knowledge, skills, and experience. The total package will include equity, in addition to a full range of medical and/or other benefits, depending on the position offered. Pay and benefits are subject to change at any time, consistent with the terms of any applicable compensation or benefit plans. 

You also get:

• Comprehensive benefits including above market Health, Dental, Vision
• Family friendly environment 
• Flexible time off
• 401k plan
• Free PicnicHealth account
• Equipment and internet funds for home office set up 
• Wellness Stipend

Equal Opportunity Statement

PicnicHealth is committed to promoting an inclusive work environment free of discrimination and harassment. We value a diverse and balanced team where everyone can belong.