MDWerks Inc.

• Develop and lead the global Medical Affairs strategy aligned with clinical development plans and commercial objectives • Serve as a key medical voice in cross-functional leadership discussions, including Clinical, Regulatory, Commercial, and Market Access • Translate clinical and scientific data into impactful medical strategies that support product differentiation and value demonstration • Build and maintain relationships with Key Opinion Leaders (KOLs), academic institutions, and clinical investigators • Represent the company at scientific congresses, advisory boards, and external forums • Lead and support advisory board strategy and execution • Provide strategic oversight of HEOR, including real-world evidence (RWE), outcomes research, and value-based evidence generation • Develop and oversee the global strategy for corporate sponsorships, grants, and charitable contributions in alignment with medical and scientific priorities • Lead team in identifying and building relationships with key patient organizations • Provide scientific insights for the development of economic models, burden-of-disease studies, and comparative effectiveness research • Partner closely with Clinical Development on trial design, investigator engagement, and data interpretation • Collaborate with Commercial and Market Access teams to ensure scientific alignment and appropriate support of launch readiness • Contribute to regulatory strategy and interactions, as needed • Play a leadership role in preparing for first product launch, including scientific platform development and field medical readiness • Ensure generation and communication of data supporting product value proposition

• Lead the design, implementation, and administration of the company’s total rewards strategy. • Develop and execute a comprehensive total rewards strategy aligned with business goals. • Serve as the subject-matter expert for compensation, benefits, and equity programs. • Establish governance processes, policies, and controls to support rewards practices globally. • Design and manage competitive benefits programs, including health and welfare, retirement, time-off, allowances, and wellbeing initiatives. • Ensure compliance with all applicable compensation and benefits regulations. • Serve as a strategic advisor to HRBPs and business leaders on rewards-related decisions.

• The NSD will serve as a senior field leader responsible for building and leading a high-performing commercial organization across a large U.S. geography in support of Mineralys’ first product launch. • This role will lead a team of Regional Sales Directors and their sales teams, ensuring flawless launch execution, strong customer engagement, and achievement of business objectives. • The NSD will act as a strategic business partner to the VP of Sales and cross-functional leadership team, helping shape launch strategy, field execution plans, talent development, and organizational culture.

• Manage routing and tracking of promotional materials through the review process (from submission to final approval). • Align on reviewer expectations, timing, prioritization, and cross functional readiness. • Serve as the meeting facilitator for the material review meetings, setting agendas and managing post-review outcomes (such as: resubmissions and approval documentation). • Ensure requested changes are captured and material sponsors and agency partners take responsibility to ensure changes are pulled through on materials. • Develop strong expertise in submission platforms (e.g., Veeva), and approval workflows. • Works with the marketing operations leader to guide and train promotional material sponsors and agencies on submitting compliant materials, review timelines, and planning approvals. • Works with the team and senior management when there is agreement to escalate materials for additional discussions by following established escalation procedures. • Collaborate with the marketing operations leader, material sponsors and agencies on final distribution requirements for print and digital materials. • Partner with operations leader and Regulatory Reviewer to ensure workflows for 2253 submissions are in place and track submission status. • Work closely with marketing and field sales to ensure materials are not distributed until final approval for distribution is granted following 2253 submission (if required). • Partner with marketing operations leader (and other key stakeholders) to update workflows, SOPs, and quality controls for promotional review.

• Own end-to-end implementation of the commercial and medical affairs technology stack. • Stand up the field force toolkit operational on day one. • Partner daily with the Heads of Sales, Marketing, Market Access, and Medical Affairs. • Drive adoption across commercial and medical affairs. • Co-own the technology roadmap with leadership.

• Develop and own the end-to-end sales training and effectiveness strategy aligned to launch milestones and commercial objectives • Establish a clear field capability model spanning disease education, product knowledge, selling skills, account management, and compliant execution • Serve as the single point of accountability for field readiness and training excellence • Lead initial sales force onboarding and certification, ensuring readiness at launch • Design and execute launch training, POA meetings, workshops, and reinforcement plans • Partner closely with Marketing, Medical Affairs, and Compliance to ensure aligned, accurate, and approved content • Build and deliver ongoing training curricula to support continuous performance improvement • Develop leadership and coaching capabilities for first-line and second-line field leaders • Leverage blended learning approaches (live, virtual, digital, field-based) • Drive field force effectiveness by ensuring training and field insights support commercial strategy and execution • Partner with Sales Leadership and Commercial Analytics to identify skill gaps, performance trends, and execution opportunities • Establish performance indicators to assess and optimize launch performance and training/field effectiveness • Translate field insights into targeted training and enablement interventions • Act as a strategic liaison across Sales, Marketing, Medical Affairs, Market Access, and Compliance • Ensure consistent messaging, execution standards, and compliance across all customer-facing roles • Onboard and manage external training vendors and learning partners

• Execute outsourcing strategies for clinical trials in collaboration with Clinical Development that supports the business needs and maximizes return on investment. • Lead RFI/RFP processes, vendor evaluations, and bid defense meetings to select CROs, Labs, RTSM, electronic Clinical Outcome Assessments, Blood Pressure Monitoring, and other various specialty vendors in collaboration with a cross-functional team. • Ensure all outsourcing activities are conducted in a manner that conforms to an ethical process as well as adherence to all applicable internal and external compliance standards, processes, and guidelines. • Negotiate and manage MSAs, work orders, and change orders in collaboration with Legal; ensure completeness, accuracy, and appropriate business terms (pricing, deliverables, milestones, payment schedules, and performance measures). • Work cross-functionally to lead and manage special project initiatives such as preferred provider relationships, functional service provider models (FSP), strategic partnerships, standardization initiatives, metrics/KPIs, SOP development, and training programs. • Drive standardization and process improvement across vendors to ensure consistency and operational efficiencies • Collaborate with internal team members to manage vendor relationships and to resolve any vendor performance issues. • Partner with Finance to forecast study budgets and manage financial accruals. • Partner with Clinical Operations, Regulatory, Quality, and Finance teams to drive operational excellence and compliance. • Train and educate clinical development and other relevant functional areas on outsourcing activities, processes, and requirements

• Lead systems implementation projects across the full SDLC, including requirements definition, solution design, configuration, integration, testing, deployment, and transition to operations. • Develop and maintain integrated project plans, timelines, risks, and dependencies to support successful delivery and go‑live readiness. • Own execution quality, issue resolution, and progress tracking to ensure predictable, well‑managed outcomes. • Manage cross‑functional project teams spanning IT, Quality, business functions, and external vendors. • Partner closely with business and system owners to translate operational needs into clear system requirements and implementation plans. • Coordinate vendor delivery, ensuring alignment to scope, schedule, quality expectations, and Mineralys standards. • Ensure system implementations comply with applicable regulatory, data integrity, and electronic records requirements (e.g., GxP, SOX, 21 CFR Part 11), where applicable. • Coordinate Computer System Validation (CSV), SOX, or other compliance activities in partnership with system owners, business owners, and Quality. • Maintain appropriate project and system documentation to support audits and inspections. • Ensure projects align with established IT governance, architectural principles, cybersecurity requirements, and data management standards. • Support user adoption, training readiness, and operational handoff to ensure systems deliver sustained business value. • Contribute to the development and continuous improvement of IT project delivery practices, tools, and frameworks across the enterprise.

• develop and execute a comprehensive talent strategy aligned to the company's commercial launch priorities and long-range business plan • serve as a thought partner and advisor to the executive leadership team on all matters related to people, organizational design and workforce planning • lead a high-performing talent team, establishing clear roles, accountabilities and a culture of excellence within the function • establish talent metrics, KPIs and dashboards that provide data-driven insights to inform business decisions and demonstrate ROI of talent investments • architect and lead a proactive, full-cycle talent acquisition function capable of scaling rapidly to support commercial launch hiring across commercial, medical affairs, market access and G&A functions • champion and amplify a compelling employer brand that distinguishes Mineralys in a competitive biotech talent market • design a remote-first onboarding experience that intentionally builds cultural connection, peer relationships and role clarity in the absence of daily physical presence • oversee the design of a modern performance management philosophy balances accountability with growth, grounded in regular feedback, meaningful coaching conversations and a shared commitment to continuous development • own the end-to-end employee experience with a relentless focus on creating an environment where talented people choose to do their best work • design and administer engagement surveys, pulse checks and listening mechanisms that generate actionable insight; ensure leaders are equipped and accountable to act on feedback

• Serve as the clinical lead for one or more clinical programs, with responsibility for clinical trial design, execution oversight, and delivery of key milestones • Lead development of clinical plans, protocols, amendments, , and related study documents • Provide medical oversight for Phase 2/3 and/or registrational studies, ensuring patient safety, data integrity, and operational excellence • Partner with Clinical Operations, Biostatistics, Data Management, Regulatory, and Safety to ensure efficient study execution and timely issue resolution • Drive study start-up, enrollment, interim analyses, database locks, topline results, and CSR delivery • Serve as medical monitor for assigned studies, including review of eligibility, protocol deviations, safety signals, SAEs/AEs, and benefit-risk assessments • Collaborate with Pharmacovigilance on safety surveillance, signal detection, DSMB materials, and aggregate safety reporting • Support development of risk mitigation strategies and ensure patient safety remains central throughout program execution • Contribute to global regulatory strategy and interactions with health authorities (FDA, EMA, PMDA, etc.) • Author and review clinical sections of regulatory documents, including briefing books, protocols, CSRs, IBs, and submission modules • Present clinical data and strategy to regulators, internal governance committees, and senior leadership • Serve as the key clinical voice on cross-functional program teams • Partner with Translational Medicine, Biomarkers, Medical Affairs and Commercial to align development strategy with future launch needs • Support publication planning, congress presentations, and external scientific engagement • Build strong relationships with KOLs, investigators, and external experts • Mentor internal team members and external consultants/CRO partners • Foster a culture of collaboration, accountability, urgency, and quality • Operate effectively in a lean biotech environment where flexibility and ownership are essential.