Full Time, U.S. Remote

Our vision is to make mental health radically accessible.

We’re on a mission to address the vast unmet need for improved mental health outcomes across health systems globally.

We are a team of innovators, experts and business builders who have come together to develop a new generation of technologies that can transform mental healthcare. We’ve developed Woebot, our proprietary relational agent, to help people engage more deeply and continuously in their mental health at scale.

Woebot generates human-level rapport through text-based conversations that use the latest research in NLP, ML and other core technologies. Leveraging this therapeutic bond, Woebot delivers high quality CBT-based therapy that targets user’s needs with tools translated by our team of expert clinicians and scientists.

Job Summary

The Head of Safety and Device Vigilance will be responsible for the strategic implementation, execution, and management of Device Vigilance and risk management activities in conjunction with Woebot’s development and commercial activities. 

They must effectively collaborate cross-functionally at all levels in the organization as well as with external safety service providers and regulatory authorities including those in the US and EU.

The Head of Safety and Device Vigilance will lead and is accountable for providing strategic clinical and safety oversight for all Device Vigilance functions which includes but is not limited to: 

Oversee and lead the signal assessment and management process in conjunction with the Safety Assessment Committee (SAC) and external vendors (ie CROs) Participation in, management and oversight of the Safety Assessment CommitteeManagement and mentoring of the device safety team, Product benefit- risk management including and proactive safety signaling and timely benefit- risk assessments of safety data Oversight of Safety Operations and documentation including selection, management and oversight of safety database vendors; Leadership in addressing any external questions related to product safety Leadership in ensuring compliance with all safety and device event reporting timelines.

The candidate will play a visible role towards providing safety leadership and advisement in company-wide forums and initiatives.

Your First 90 Days

• Onboard and review the Device Vigilance SOPs to understand current ways of working 
• Meet with Regulatory, Clinical, Medical and Development to lead Device Vigilance function and inform DV strategy 
• Handover activities alongside the current Head of Device Vigilance
• Lead the first Safety Assessment Committee, acting as chair to compile the product benefit-risk profile 
• Provide Device Vigilance insight into trial design for future Woebot Health trials

Key Responsibilities

• Lead, oversee and direct all aspects of Device Vigilance and risk management activities for development products and potential marketed products
• Maintain and further build-out the safety management system to accommodate additional trials and eventual commercial launch
• Receive and review incoming clinical and commercial device reports for (1) company assessment of causality, (2)risk and need for escalation to SAC, and (3) reportability
• Co-develop and review Safety Management Plans (SMPs)
• Acquire a deep understanding of the disease process in the mental health space as well as competitor updates
• Own and drive the maintenance of WH product(s) benefit- risk profile including a working knowledge of other company products in development
• Actively contribute to oversight of patient safety in all ongoing clinical trials
• Design, direct, and conduct ongoing safety surveillance of Woebot Health trials using internal and external resources (e.g. CROs) to ensure delivery of high-quality PV services
• Help negotiate contracts for, interact with and supervise the activities of CROs and vendors for Device vigilance services
• Provide ongoing updates to the C-suite and Executive Core Team members on the changing benefit- risk profile of our products and competitors’ products, based on analyses/evaluation of potential safety signals.
• Implement appropriate safety updates and risk mitigation plans.
• Provide strategic planning, implementation, and management of device safety and vigilance activities to support clinical development of company products and actively contribute to corporate risk management related to device safety
• Provide oversight of all clinical safety activities including review of medical coding of AEs, con-meds, and processing of device and safety events through the entire lifecycle including preparation of analyses for unanticipated adverse device events (UADEs)
• Lead responses and resolutions to safety questions from regulatory authorities, as well as regulatory agency audits/inspections, and corrective action plans
• Direct the development, preparation, and compliance of periodic and annual safety reports (e.g., DSUR-if applicable), investigator communications, product labeling and other reports as necessary that relate to product device safety
• Provide expert safety review input into all critical documents for clinical development plans of products (e.g., clinical study, protocols and amendments, ICFs, IBs, IMPDs, support DMCs, clinical safety reports, IDEs, CTAs, as applicable)
• Ensure departmental budgets and schedules meet corporate requirements
• Manage internal staff and work to establish the permanent Device Safety Team overseeing both internal employees and external contractors to ensure delivery of quality safety and device vigilance services
• Monitor industry best practices and changes in global safety regulations and guidelines- especially in the device space.
• Recommend changes and upgrades to existing departmental policies, SOPs and systems to ensure regulatory compliance in jurisdictions where the company’s products are available
• Support the C-suite and provide strategic Medical or clinical insights to help respond to safety-related questions from external sources including the investment community
• Work effectively across functions including Clinical Development, Regulatory, Quality, Medical Affairs, Commercial, Translational Science / Intervention Science, Product and Legal to effectively perform the above responsibilities and achieve the expected risk management outcomes (ex. Support for CLMR reviews)
• Mentor team towards continuous improvement/enhancement of safety work procedures consistent with good device vigilance practices, including for regulatory inspection readiness

Role Specific Competencies

Required

• M.D./PhD/MS/MPH or PharmD is preferred
• Minimum of 10 years of experience in Device Safety in biotechnology required
• Minimum of 8 years as a direct manager within a global safety function, optimally with at least 2 years of prior device reporting experience
• Deep understanding of risks and risk mitigation steps related to safety signals and device vigilance for clinical and post marketing
• Expert knowledge of FDA safety regulations, ICH and IMDRF (International Medical Device Regulators Forum) Guidelines, EU MedDEV and other applicable regulatory guidance documents; expertise in global safety regulations, MedDRA Certified Training in SMQs and Coding
• Expert knowledge of relational database applications (including ARGUS, ARISg, or other safety databases), including optimally EudraVigilance training or other competency with E2B reportingEffective team player with demonstrated ability to solve problems with innovative solutions along with strong organizational skills
• Possess strong and dynamic leadership skills, with excellent written, verbal, and presentation skills

Ideal

• Clinical expertise in the mental health space is preferred. 
• Experience with digital therapeutics is optimal but not required

Our Core Values:

• Empathic: You’re a compassionate person and a team player motivated to understand others and help them be successful, too. You care as deeply for your colleagues as you do for our mission and our users.
• Self-aware: You possess a high level of emotional intelligence, which allows you to understand yourself and others, and to have a healthy emotional life in the workplace.
• Proactive & flexible:You are able to hit the ground running, you take responsibility for finding a way to get the job done. You learn as quickly as possible and sometimes do things outside the immediate scope of your work, giving it all you’ve got.
• Strong work-ethic: You’ve mastered healthy habits in your life that allow you to do great things. You exemplify dedication and commitment to coming up with very good results in your work and inspire others to do the same.
• Growth mindset: You believe abilities – like intelligence and talent – can be developed through dedication and hard work. You see failure as an opportunity to grow and welcome feedback as a pathway to your continued success.
• Humble: You recognize that you are one among many, and you hold a genuine desire to discover what other people can offer. You are intrigued by how others think, and how others feel differently from you. You lean into these moments with patience and curiosity.

 Benefits 

• Competitive Salary
• Stock Options 
• Flexible PTO
• Health, Dental & Vision
• Healthy Snacks & Meals

Woebot is an equal opportunity employer and we deeply value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.