Director, Expanded Access Program Operations

myTomorrows

About myTomorrows  myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options.    We strive to enable earlier and better treatment access by bridging the gap between those searching for possible options, and the companies who develop them. We work closely with patients, healthcare professionals, trial sites, patient advocacy groups, and BioPharma – connecting key stakeholders in the drug development ecosystem.    We’ve developed a cutting-edge AI-powered technology platform that simplifies and streamlines access to drugs in development. To support our users and clients, we have a range of industry-expert specialized teams ready to help. Our services include clinical trial patient recruitment, Expanded Access Program management and Real-World Data collection.    With a global footprint spanning 134 countries, to date we’ve supported over 17,000 patients, 3,000 physicians and 350 sites, earning the trust of 60+ BioPharma companies. In October 2025, we closed a €25M investment with Avego Healthcare Capital to fuel our global ambitions and scale the business.   Join us in shaping the future of treatment access - making tomorrow’s therapies accessible for people who need them today.  The Opportunity: Senior Operational Excellence Manager The Senior Operational Excellence Manager Improves operational processes to enhance efficiency, effectiveness, scalability and quality across myTomorrows. The role identifies, analyzes, and optimizes business processes using data-driven insights to achieve sustainable improvements, ensuring processes align with organizational objectives and supporting a culture of continuous improvement. This role will report to the Director, Operational Excellence (Diane says hi!). You'll be joining a small Operational Excellence function with a portfolio of active initiatives already in flight. The function has foundations in place, but there is meaningful room to shape how things are done; this is not a role where you inherit a fully-defined playbook and execute against it. If you're energized by a mix of picking up existing work and putting your own stamp on it, this is a strong fit. This role is hands-on and cross-functional. Success requires strong stakeholder management, excellent documentation discipline, and the ability to implement change effectively in an environment where teams are busy. The role also serves as a key interface between Operations and Product Development to ensure operational processes are effectively enabled by systems and tooling, including AI and automation capabilities. Key Responsibilities * Lead operational excellence initiatives: Identify inefficiencies, run root-cause analysis, and deliver scalable process improvements with measurable outcomes (end-to-end: definition → design → implementation → adoption → tracking). * Project oversight: Manage scope, plans, dependencies, risks, and stakeholder actions across multiple initiatives to ensure high-quality delivery and on-time implementation. * Ops ↔ Product interface (systems enablement): Translate operational needs into clear requirements, support implementation of system/process changes, and ensure solutions work in real operational workflows. * AI & automation integration: Identify where AI tools and automation can meaningfully reduce manual effort, improve consistency, or accelerate throughput. * Collaborate with the AI/Automation workstream to scope, test, and embed solutions into operational processes — maintaining appropriate human oversight, especially in regulated contexts. * Evaluate AI output quality as part of process design, not as an afterthought. * Lead GxP / CSV related implementations: Partner with Quality and Product to support and/or lead Computer System Validation (CSV) for GxP-touching systems, ensuring appropriate documentation, test evidence, traceability, training alignment, and change control as applicable. * Stakeholder & change management: Influence without authority, align priorities, and drive adoption through practical rollouts that respect operational workload constraints and provide enablement. * Documentation excellence: Create and support maintaining high-quality process documentation (process maps, SOPs/work instructions, templates, decision logs). * Establish standards and ways of working so teams can document consistently, accurately and keep it current, including how AI-generated content is reviewed, versioned, and approved. * Training & embedment: Develop training materials and deliver/coordinate training to ensure process changes are adopted and sustained including support to the AI enablement team to help build capability in the team’s use of AI tools where relevant. * Data & KPI management: Define KPIs upfront per initiative; measure, track, analyze trends, and report impact using data analytics tools. Requirements * Experience: 4–6+ years in Operational Excellence / Process Improvement / Operations, with demonstrated success leading cross-functional improvement initiatives. * Proven experience operating in validated environments and executing/participating in CSV activities for GxP-touching systems. * Comfortable working with AI tools in a professional context, not necessarily as a builder, but as a critical and informed user. * Strong capability in process analysis, continuous improvement methods, and data-driven decision making. * Experience with project/process management tools; Smartsheet a plus. * Excellent communication and stakeholder management skills; ability to drive change in fast-paced operational settings. * Comfortable operating in a maturing function where frameworks are being built, not just inherited. * Strong writing skills and a high bar for documentation quality; ability to coach and enable others to follow the same standards. * Highly preferred: work experience in life sciences (e.g., drug development, expanded access programs, clinical trial recruitment) and/or highly regulated environments. Equal opportunities myTomorrows is an Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated. The best work comes from our best selves, and we go to great lengths in supporting our team members to be just that.

myTomorrows

About myTomorrows  myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options.    We strive to enable earlier and better treatment access by bridging the gap between those searching for possible options, and the companies who develop them. We work closely with patients, healthcare professionals, trial sites, patient advocacy groups, and BioPharma – connecting key stakeholders in the drug development ecosystem.    We’ve developed a cutting-edge AI-powered technology platform that simplifies and streamlines access to drugs in development. To support our users and clients, we have a range of industry-expert specialized teams ready to help. Our services include clinical trial patient recruitment, Expanded Access Program management and Real-World Data collection.    With a global footprint spanning 134 countries, to date we’ve supported over 17,000 patients, 3,000 physicians and 350 sites, earning the trust of 60+ BioPharma companies. In October 2025, we closed a €25M investment with Avego Healthcare Capital to fuel our global ambitions and scale the business.   Join us in shaping the future of treatment access - making tomorrow’s therapies accessible for people who need them today.  THE OPPORTUNITY: REGULATORY AFFAIRS DIRECTOR As Regulatory Affairs Director, you will play a critical leadership role in translating our global regulatory strategy into execution across programs, regions, and service lines. You will oversee a portfolio of regulatory activities, ensuring high-quality, compliant, and timely delivery while leading and developing a team of Regulatory Affairs professionals. You’ll work closely with cross-functional teams and act as a senior point of contact for both internal stakeholders and external partners. This role sits at the intersection of strategy, delivery, and leadership, and is key to scaling our Regulatory Affairs capabilities globally. WHAT YOU'LL DO IN THIS ROLE: DRIVE REGULATORY STRATEGY EXECUTION * Translate company and RA/PV strategy into clear regulatory plans across programs and regions * Drive implementation across Expanded Access Programs (EAPs), Clinical Trials, and Real-World Data initiatives OVERSEE PROGRAM AND PORTFOLIO DELIVERY * Oversee multiple regulatory programs simultaneously, ensuring delivery against timelines, quality standards, and client expectations * Identify and proactively manage cross-program risks, dependencies, and resource constraints LEAD AND DEVELOP THE TEAM * Lead, coach, and develop Regulatory Affairs Managers and senior team members * Set clear expectations and drive accountability for performance, quality, and delivery COLLABORATE CROSS-FUNCTIONALLY * Partner closely with Program Management, Medical Affairs, Quality Assurance, and Supply Chain * Ensure regulatory input is embedded into end-to-end program delivery DRIVE OPERATIONAL EXCELLENCE AND PERFORMANCE * Drive standardization, consistency, and scalability of regulatory processes * Identify improvement opportunities and implement data-driven solutions ENGAGE WITH CLIENTS AND STAKEHOLDERS * Act as a senior point of contact for clients on regulatory matters * Support client discussions, audits, and regulatory interactions with Health Authorities ENSURE QUALITY, COMPLIANCE, AND RISK MANAGEMENT * Ensure adherence to global regulatory requirements and internal processes * Support inspection readiness and audit preparedness WHAT YOU BRING TO THE TABLE: * Advanced degree in life sciences, pharmacy, or a related field * Significant experience in Regulatory Affairs within pharma, biotech, or CRO environments * Proven experience managing multiple programs and complex regulatory portfolios * Strong knowledge of global regulatory frameworks (EAP, clinical trials, or similar environments) * Demonstrated leadership experience managing teams and developing talent * Excellent stakeholder management and communication skills Equal opportunities myTomorrows is an Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated. The best work comes from our best selves, and we go to great lengths in supporting our team members to be just that.

myTomorrows

About myTomorrows  myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options.    We strive to enable earlier and better treatment access by bridging the gap between those searching for possible options, and the companies who develop them. We work closely with patients, healthcare professionals, trial sites, patient advocacy groups, and BioPharma – connecting key stakeholders in the drug development ecosystem.    We’ve developed a cutting-edge AI-powered technology platform that simplifies and streamlines access to drugs in development. To support our users and clients, we have a range of industry-expert specialized teams ready to help. Our services include clinical trial patient recruitment, Expanded Access Program management and Real-World Data collection.    With a global footprint spanning 134 countries, to date we’ve supported over 17,000 patients, 3,000 physicians and 350 sites, earning the trust of 60+ BioPharma companies. In October 2025, we closed a €25M investment with Avego Healthcare Capital to fuel our global ambitions and scale the business.   Join us in shaping the future of treatment access - making tomorrow’s therapies accessible for people who need them today.  The opportunity: Regulatory Affairs & Pharmacovigilance Manager As the Regulatory Affairs and Pharmacovigilance Manager, you will be responsible for ensuring compliance of our processes with country-specific expanded access regulations globally. In this role, you'll be a key contributor to our regulatory and quality infrastructure, keeping us aligned with global legislation. You will be actively working together with Medical Affairs, Program Management, Quality Assurance, and Supply Chain and will report to the Director of Regulatory Affairs and Pharmacovigilance (Emily says hi). What you will do in this role: * Support the development and execution of regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs. * Act as the Regulatory Affairs and Pharmacovigilance expert for communications with clients (pharmaceutical companies) and submissions to Health Authorities, as well as cross-functional meetings and audits. * Prepare, compile, and submit regulatory dossiers for cohort and named patient Expanded Access Programs (EAPs) on behalf of clients. * Provide input and support for the regulatory strategy for setting up and executing EAPs (e.g., where, when, and how). * Collaborate with the Commercial team to support new EAPs. * Ensure timely and compliant handling of all regulatory and pharmacovigilance activities related to EAPs. * Stay up to date on relevant global laws, regulations, and guidelines impacting EAPs. * Assist in drafting, reviewing, and maintaining regulatory documentation and templates. * Liaise with the Pharmacovigilance service provider to ensure alignment and compliance. * Contribute to maintaining department documentation such as SOPs (Standard Operating Procedures), QIs (Quality Incidents), and CAPAs (Corrective and Preventive Actions). What you bring to the table: * 5+ years of relevant experience in Regulatory Affairs, including experience in Expanded Access. * Working knowledge of fundamental principles of Pharmacovigilance is required. * Solid understanding of national and international legislation and regulation relating to Expanded Access * A Bachelor’s or Master's degree in Life Sciences or a related field * Experience working directly with clients or external stakeholders in a professional setting * Strong communication skills (written and verbal) in English; able to convey complex topics clearly to both internal teams and external parties. Knowledge of additional languages is a plus * Comfortable collaborating across teams and working in a cross-functional environment * Proactive problem solver with the ability to identify potential regulatory or operational challenges early and suggest practical solutions * Familiarity with Microsoft 365 tools (e.g., Word, Excel, Teams, SharePoint) What we offer: * Impactful work that helps patients gain access to potentially lifesaving treatments. * International work environment, scale-up energy and flat organizational structure which encourages creativity and accountability. * Competitive salary, annual performance bonus and an Employee Stock Option Plan. * Great career development opportunities in a fast-growing company. * Learning and development budget alongside internal knowledge sharing sessions. * Hybrid working model if you're in the Netherlands. * Policies to support working parents. * Healthy lunch at the thriving Amsterdam office. * Unlimited access to professional guidance by certified psychologists via OpenUp * Enjoy monthly events hosted by our vibrant Culture Club as well as an annual ‘myTomorrowland’ company-wide celebration! Equal opportunities myTomorrows is an Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated. The best work comes from our best selves, and we go to great lengths in supporting our team members to be just that.