Regulatory Affairs Manager (Expanded Access Programs)

MoonLake Immunotherapeutics

JOB PURPOSE The VP Marketing will lead the development and execution of MoonLake Group’s marketing strategy, building a strong, differentiated brand foundation to support the product and future indication launches and long-term growth. This role is responsible for shaping the company’s commercial narrative, ensuring strategic alignment across functions, and translating scientific innovation into clear, compelling value for key stakeholders, including healthcare professionals, patients, and internal leadership. YOUR PROFILE Major Accountabilities * Marketing Strategy: Lead US marketing and brand plan incl. differentiation, positioning and tactics across the product lifecycle, aligned with MoonLake’s clinical stage, corporate objectives, and commercial ambition.  * Pre-Launch & Launch Readiness:  * Execute US pre-launch strategy and launch readiness, including positioning, messaging, segmentation, and execution planning to ensure successful market entry. * Oversee MoonLake’s HCP and Consumer promotional campaign and activity. * Oversee MoonLake’s Peer to Peer, congress and KOL engagement.  * Insight-Driven Decision Making: Drive marketing strategy through deep customer, market, and competitive in-sights, ensuring clear prioritisation and measurable impact.  * Cross-Functional Leadership: Partner closely with Commercial, Medical Affairs, Market Access, Regulatory, and Legal to deliver integrated, compliant marketing programmes. * Omnichannel Execution: Oversee US omnichannel engagement strategies that effectively reach and influence key healthcare stakeholders. Ensure Omnichannel orchestration execution at launch by wining with Data and Technology. * Team Leadership: Build, lead, and establish a high-performing US marketing organisation with clear accountability and strong executional excellence.  * Agency & Budget Oversight: Lead external agency relationships and marketing investment, ensuring high-quality delivery, operational rigour, and financial discipline.  * Commercial Leadership Contribution: Serve as a senior commercial leader, providing strategic input to executive leadership on US commercial planning and growth decisions. Job Requirements Education: * Bachelor’s degree required * Advanced degree (MBA, PhD, PharmD, or MD) strongly preferred Experience: * 15+ years of progressive biopharma commercial experience * Significant experience in immunology, or dermatology markets  * Demonstrated leadership of pre-launch and launch marketing * Experience with competitive launch environments  * Deep familiarity with FDA promotional regulations and governance  * Proven success building and leading high-performing marketing teams  * Strong ability to translate complex clinical data into compelling value stories  * Experience managing top-tier agencies and sizable marketing budgets  * Executive presence with confidence engaging senior leadership  * Track record of effective cross-functional partnership  Skills/knowledge/behavioural competencies: * Strategic leadership and ownership * Strong scientific and commercial judgement to challenge the status quo * Effective cross-functional influence * Results-driven execution in a Biotech environment WHY US? An exciting job opportunity awaits you! MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team. What we offer: Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment. Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare. Flexibility and Balance: Enjoy a healthy work-life balance while making meaningful contributions to our team. Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.

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 Join us in shaping the future of treatment access - making tomorrow’s therapies accessible for people who need them today. As a Product Marketing Manager at myTomorrows, you will define how our products are positioned, understood, adopted, and embedded into real-world clinical and research workflows across the global healthcare ecosystem. Your focus is on product positioning, adoption, and real-world clarity, translating complex product capabilities into clear, real-world value for key stakeholders You will sit at the intersection of Product, Commercial, and Medical, bringing customer and user insight into how our solutions are positioned, communicated, and adopted by key stakeholders. What you'll do in this role * Own the Product Narrative: Shape and refine the end-to-end narrative across clinical trials and Expanded Access, clearly differentiating myTomorrows from legacy databases and lead-gen platforms. * Drive Adoption: Translate physician workflows and trial site needs into scalable messaging frameworks that remove friction and increase user engagement. * Bridge the Gap: Act as the voice of the market; synthesize insights from sites, physicians, and sponsors to feed actionable requirements back into the Product team. * Enable Teams: Build product-native enablement assets (narratives, workflow diagrams, value frameworks) to empower Commercial, Medical, and Growth teams. * Lead Product Launches: Own product readiness for new features and launches, ensuring internal alignment on messaging and use-case clarity.   What you bring to the table * Must-Have Requirement: Deep, proven experience within the BioPharma, Clinical Trials, or Expanded Access (EAP) ecosystem. Understanding the complex regulatory, operational, and protocol-driven constraints of this industry is essential for this role. * Experience: 4–6 years in Product Marketing or Product Strategy within HealthTech, digital health, or biopharma. * Storytelling & Structure: Exceptional structured thinking with the ability to map complex product capabilities to real-world user outcomes. * Execution: Relentless ownership and follow-through—you take accountability for outcomes, not just outputs. * Cross-Functional Agility: Comfortable navigating 0-to-1 environments and collaborating closely with Product, Commercial, and Medical stakeholders. * User Empathy: Deep understanding of the distinct workflows and pain points of trial sites, rare disease ecosystems, and pharma teams. Geographic Requirement: To ensure seamless collaboration with our teams, applicants must reside within the EST time zones. Applications outside of these time zones will not be considered. What success looks like in 6 months * One Unified Story: A clear, jargon-free product narrative that the Commercial and Medical teams can pitch confidently in under 60 seconds. * Data-Driven Impact: Improved referral-to-enrollment conversion driven by clearer workflow communication and localized messaging. * Feedback Loop: An established, fast-paced insight loop between users and the product team, replacing internal assumptions with real-world clinical realities. What we offer * Impactful work that helps patients gain access to potentially lifesaving treatments. * International work environment, scale-up energy, and a flat organisational structure encouraging creativity and accountability. * Competitive salary, annual performance bonus, and an Employee Stock Option Plan. * 401K: Every US employee will be automatically enrolled in a 401(K) retirement plan * Paid time off: 25 days per year for full-time employees. * Sick leave: 5 days/ year at 100% paid. * Great career development opportunities in a fast-growing company. * Learning and development budget alongside internal knowledge sharing sessions. 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.

MoonLake Immunotherapeutics

JOB PURPOSE The VP Market Access & Pricing will end-to-end execute the group-wide applicable U.S. market access and pricing strategy incl. formulary placement, rebating, payer engagement, contracting & negotiations, deal analytics, gross-to-net forecasting, payer marketing, value proposition, HEOR, etc.  This position will implement the strategic and operational blueprint required to secure timely, favourable, and sustainable access while building the infrastructure needed to execute at launch and scale post-launch. Beyond core access, the role will drive and oversee the build-up of key infrastructure across trade and distribution (incl. specialty pharmacy and specialty distribution) as well as patient services offerings (e.g., hub, free goods, affordability).  In addition, the role executes the global access and pricing agenda and evaluates access potential in additional geographies, implements pre-defined market access strategies for priority ex-U.S. markets incl. evaluating implications of international reference pricing and most-favoured-nation dynamics, and supporting portfolio and BD decisions. YOUR PROFILE Major Accountabilities * Access strategy & leadership: Implement the group-wide applicable U.S. market access strategy across pricing, contracting, payer engagement, payer marketing, channel strategy, patient support, and field reimbursement.  * Pricing strategy: Lead execution of the U.S. pricing strategy, incorporating competitive landscape, analogs, value differentiation, expected access hurdles, channel economics, and lifecycle considerations. * GTN forecasting & financial planning: Own gross-to-net strategy and forecasting, including payer-specific assumptions, waterfall design, scenario planning, budget implications, and alignment with fi-nance and leadership.  * Contracting strategy & deal modelling: Establish the contracting framework across commercial and government channels, as well as rebate and discount archetypes, and oversee payer-specific deal models to assess access, financial, and operational trade-offs. * Payer engagement and negotiation: Map and prioritize national and regional commercial payers and direct priority payer engagement and escalation strategy, support key formulary and account interactions, drive payer negotiations and ensure clear feedback loops from payers into pricing, contracting, marketing.  * Payer marketing & value communication: Oversee development of the payer value proposition and payer-facing materials, including PIE strategy, AMCP dossier direction, value decks, objection handlers, and field tools, in close partnership with Medical, HEOR, Legal, and Regulatory.  * Trade & distribution strategy: Provide leadership across the U.S. distribution model, including specialty pharmacy, specialty distributors, and broader channel design; guide partner selection, commercial terms, data-sharing expectations, and operational readiness.  * Patient services, hub & FRM setup: Oversee the patient support model, including hub scope, affordability programs, specialty pharmacy coordination, FRM model, SOPs, governance, KPIs, and compliant workflows to reduce friction for providers and patients.  * Access data & operations infrastructure: Set direction for access data strategy across hub, SP/SD, and aggregator feeds; ensure KPI definitions, reporting requirements, data governance, dashboards, and vendor accountability are in place ahead of launch. * Government pricing: Support government pricing requirements, including foundational readiness for Medicaid rebate obligations, 340B considerations, and related operational pro-cesses and controls. * Team build & vendor leadership: Shape the market access organization structure and hiring across pricing, payer accounts, payer marketing, trade, patient services/FRM, and access operations; lead selection and oversight of critical external vendors and partners.  * Cross-functional alignment & compliance: Partner closely with Finance, Medical, Legal, Regulatory, Compliance, Supply Chain, Commercial Operations, and IT to build a launch-ready, compliant, and scalable market access capability.  * Global access: Support in identifying possible international access and pricing opportunities as well as evaluating International Reference Pricing and Most‑Favoured‑Nation dynamics; execute access and pricing strategies for priority markets; support assessment of portfolio and BD opportunities. Job Requirements Education: * Bachelor’s degree required * Advanced degree (MSc, MBA, PhD, PharmD, or MD) strongly preferred Experience: * 5-10 years of relevant biotech / pharmaceutical experience across U.S. market access, pricing, payer engagement, and commercialization, including significant launch experience in specialty or rare disease.  * Deep expertise in U.S. pricing and access strategy, payer contracting, rebate structures, deal modelling, gross-to-net forecasting, and formulary / policy dynamics across commercial and government channels. * Strong understanding of the U.S. payer ecosystem, including national and regional health plans, PBMs, GPOs, IDNs, Medicare, Medicaid, etc.  * Broad knowledge of specialty trade and distribution, including 3PL, specialty pharmacy, specialty distributor as well as patient services, hub models, affordability pro-grams, specialty pharmacy coordination, and field reimbursement * Excellent communication, financial acumen, and executive presence, with the ability to translate complex trade-offs into clear recommendations for leadership.  * Strong ability to translate complex clinical data into compelling value stories  * Executive presence with confidence engaging senior leadership  * Track record of effective cross-functional partnership Skills/knowledge/behavioural competencies: * Strategic leadership and ownership * Strong scientific and commercial judgement to challenge the status quo * Effective cross-functional influence * Results-driven execution in a Biotech environment WHY US? An exciting job opportunity awaits you! MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team. What we offer: Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment. Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare. Flexibility and Balance: Enjoy a healthy work-life balance while making meaningful contributions to our team. Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.