Mineralys Therapeutics

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. Associate Director / Director Biostatistics The Associate Director / Director, Biostatistics will lead the full scope of statistical strategy and execution for clinical development programs at Mineralys. This individual is accountable for the design, analysis, and interpretation of clinical trials, as well as statistical contributions to regulatory submissions, including NDA readiness. Operating in a fast-paced, pre-commercial biotech environment, this role requires a strong balance of strategic thinking and operational oversight, with high visibility across Clinical, Medical, and Regulatory teams. Key Responsibilities - Lead the full scope of Biostatistics activities for assigned clinical programs or indications - Define and execute statistical strategies for clinical trials and regulatory submissions - Design clinical studies, including endpoints, estimands, and sample size calculations - Serve as statistical lead on Study Executive Teams and Clinical Development Teams - Provide quantitative input into clinical development plans, including Go/No-Go criteria and probability of technical success - Ensure quality and timely delivery of statistical outputs, including interim, final, and integrated analyses - Contribute to regulatory submissions (e.g., NDA) and represent Biostatistics in interactions with FDA - Collaborate cross-functionally with Clinical, Medical, and Regulatory - Oversee CROs and/or internal teams; ensure quality, timeliness, and compliance of deliverables - Collaborate with internal leaders of Statistical Programming and Data Management - Supervise statistical programmers for QC and validation activities - Interpret analysis results and ensure accuracy in study reports, publications, and regulatory documents - Contribute to abstracts, posters, and presentations for internal and external stakeholders - Drive continuous improvement initiatives within Biostatistics and cross-functional processes Qualifications - PhD in Biostatistics, Statistics, or related field with ~8+ years of industry experience OR MS with ~11+ years of experience in drug development - Pharmaceutical/biotech industry experience required - Demonstrated experience providing statistical leadership at study or program level - Strong experience designing clinical trials and collaborating with cross-functional teams - Experience supporting regulatory submissions (NDA/BLA) - Experience interacting with regulatory authorities preferred - Experience overseeing CROs or external vendors - Experience supervising programming deliverables or QC activities - Strong knowledge of CDISC standards, data structures, and statistical methodologies - Working knowledge of SAS and/or R (oversight level, not heavy programming) - Experience with outcomes research preferred - Therapeutic area experience flexible; preference for chronic diseases or larger patient populations Core Competencies - Strong understanding of clinical development processes and regulatory expectations - Ability to lead and influence in a matrixed environment - Excellent communication skills; able to translate statistical concepts to non-statistical audiences - Demonstrated ability to balance urgency with quality - Analytical rigor with a pragmatic, execution-oriented mindset - Experience applying innovative statistical methodologies Travel - This position requires up to 10% travel. Frequently travel is outside the local area and overnight. This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level. US Salary Range: $200,000 - $230,000 #LI-Remote

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. Senior Director, Global Marketing Reporting to the CCO, the Senior Director, Global Marketing will lead the development and execution of the ex-U.S. commercial strategy. This individual will play a critical role in shaping global market strategy, ensuring alignment with U.S. commercial objectives, and optimizing long-term global revenue potential. This role requires a highly strategic and analytical leader who can operate cross-functionally across commercial, clinical, regulatory, and business development to define market entry strategies, influence development programs, and secure partnerships across key international markets. Key Responsibilities: Global Commercial Strategy (Ex-U.S.) - Lead global (ex-U.S.) market identification, prioritization, and segmentation across key geographies - Develop and execute go-to-market strategies tailored by geography and indication - Define optimal pathways to market entry, including indication prioritization Cross-Functional Leadership - Partner closely with Clinical and Regulatory teams to shape development programs that align with commercial objectives and regulatory requirements - Influence clinical study design and sequencing to maximize global commercial opportunity - Ensure alignment across stakeholders to maintain a unified strategy - Partner with Market Access to evaluate pricing and reimbursement dynamics across international markets, including health technology assessment (HTA) environments - Identify and mitigate risks related to international reference pricing and Most Favored Nation (MFN) implications Business Development & Partnerships - Lead business development efforts to identify, evaluate, and secure strategic partners for market entry - Structure and support partnership models (e.g., licensing, co-promotion, regional partnerships) - Manage partner strategy to ensure successful execution in priority markets Strategic Analytics & Decision-Making - Conduct rigorous market assessments, including epidemiology, competitive landscape, and access dynamics - Develop commercial forecasts and scenario analyses to inform prioritization and investment decisions - Provide strategic recommendations to senior leadership based on data-driven insights Required Experience: - 10+ years of biopharmaceutical commercial experience, including global or ex-U.S. marketing - Demonstrated success in multi-market strategy development and execution - Strong experience in chronic disease markets; cardiovascular experience preferred. - Proven ability to collaborate with clinical and regulatory teams to shape development programs - Experience in early-stage or pre-market environments (Phase II or earlier strongly preferred) - Track record of business development and partnership execution Capabilities & Skills - Exceptional analytical and strategic thinking skills, particularly in market access and pricing dynamics - Deep understanding of global reimbursement systems and HTA bodies (e.g., Europe, Japan) - Strong ability to navigate complex trade-offs between global and U.S. commercial strategies - Excellent cross-functional leadership and influence skills - Ability to operate effectively in a fast-paced, emerging biotech environment Travel - This position requires up to 20% travel. Frequently travel is outside the local area and overnight. These positions are eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level. US Salary Range: $250,000 - $265,000 #LI-REMOTE

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. The Director / Sr Director, Human Resources – Commercial will serve as the primary HR Partner to Mineralys’ Commercial organization as the company prepares for its first commercial launch. This role will act as a trusted advisor to business leaders, aligning people strategies with commercial objectives while fostering a high-performance, compliant, and values-driven culture in a rapidly scaling, highly regulated environment. Key Responsibilities Strategic Business Partnership - Serve as a strategic HR partner to Commercial and Field leadership across Sales, Marketing, Market Access, Training and Commercial Operations - Translate commercial objectives into integrated people strategies that support rapid growth, capability building, and organizational effectiveness - Provide data-driven insights and recommendations on workforce planning, organizational design, job architecture, compensation planning and talent needs as the Commercial organization scales Talent Management & Development - Partner with leaders on talent assessment, succession planning, and leadership development initiatives - Supports annual objective setting and mid-year and year-end performance assessment processes - Participates in the design and execution of field incentive compensation programs - Supports all performance management processes, including coaching, feedback, and development planning - Identify capability gaps within the Commercial organization to deliver targeted development solutions Employee Relations & Engagement - Act as a first point of contact for employee relations matters, ensuring fair, consistent, and timely resolution in compliance with company policies and employment laws - Coach managers on effective people leadership, engagement, and change management during periods of growth and transformation - Support employee engagement initiatives that reinforce Mineralys’ values of Collaboration, Integrity, Quality, Trust, and Urgency Change Management & Organizational Effectiveness - Lead and support change management efforts related to commercial build-out, launch readiness, and evolving operating models - Support commercial teams to ensure alignment and consistency across a geographically dispersed workforce Compliance & Governance - Ensure adherence to all employment laws, regulatory requirements, and internal policies, particularly in a pharmaceutical commercial environment - Partner with Legal and Compliance to mitigate risk and support sound, compliant people decisions Qualifications Required - BS/BA degree in Human Resources, Business Administration, or a related field - 7+ years of progressive HR experience, with demonstrated success as an HR Business Partner - Experience supporting Commercial organizations, preferably within pharmaceutical, biotech, or life sciences companies - Strong knowledge of U.S. employment law and HR best practices - Proven ability to influence and partner effectively with senior leaders - Excellent communication, coaching, and problem-solving skills Preferred - Master’s degree or HR certification (e.g., SHRM-CP/-SCP, PHR/SPHR) - Experience supporting field-based sales organizations, including periods of rapid growth or launch - Familiarity with specialty pharma, rare disease, or launch-stage commercial models - Experience working in a matrixed, fast-paced, early-stage environment Travel - This position requires up to 10% travel. Frequently travel is outside the local area and overnight. US Salary Range: $200,000 - $250,000 #LI-Remote

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. Associate Director, Drug Product Development & Manufacturing We are seeking a highly motivated and experienced individual to drive drug product development, technical operations, and commercial manufacturing readiness for small molecule pharmaceutical programs. This role will lead cross-functional efforts spanning formulation development, process development, technology transfer, validation, and supply chain coordination to support clinical and commercial objectives. Key Responsibilities: - Lead development of phase-appropriate formulations and manufacturing processes for solid oral dosage forms. - Oversee technology transfer from development to clinical and commercial manufacturing. - Support process validation, process characterization, and lifecycle validation activities. - Manage CDMOs, including selection, oversight, and performance management. - Ensure uninterrupted supply of clinical trial materials (Phase I–III) and commercial launch readiness. - Define product specifications, control strategies, and ensure scalability and robustness. - Apply Quality by Design (QbD), Design of Experiments (DoE), and statistical tools to optimize processes. - Coordinate with supply chain and manufacturing to support production planning and scheduling. - Identify and mitigate risks related to supply and manufacturing. - Author and review CMC sections for regulatory submissions (IND, IMPD, NDA, MAA). - Ensure compliance with FDA, EMA, ICH, and cGMP requirements. - Support deviation investigations, CAPA, inspections, and audit readiness. - Collaborate across functions including Analytical, Quality, Regulatory, and Supply Chain. Qualifications: - Advanced degree (PhD, MS, or BS) in Pharmaceutics, Chemistry, Chemical Engineering, or related field. - 10+ years of experience in pharmaceutical drug product development. - Experience supporting products from early development through commercialization preferred. - Strong expertise in solid oral dosage forms and pediatric formulations. Analytical testing understanding is a plus. - Hands-on experience with DoE, statistical analysis tools (e.g., JMP, Minitab). - Proven experience managing CDMOs and external partners. - Strong knowledge of cGMP, FDA, EMA, and ICH guidelines. - Experience contributing to regulatory filings and supporting inspections. - Demonstrated leadership, project management, and problem-solving skills. - Excellent communication and ability to work in fast-paced environments. Travel - This position requires up to 30% travel. Frequently travel is outside the local area and overnight. Some of the travel may be international. Position eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level. US Salary Range: $175,000 - $190,000 #LI-Remote

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. Director / Senior Director, Commercial Operations This role will be responsible for commercial operations to support the development & launch of lorundrostat in hypertension. - Guide field CRM implementation and maintenance with CRM implementation vendor based on input with cross functional field colleagues (Sales, Medical Affairs, Market Access) - Guide commercial incentive compensation design and planning based on input from cross functional colleagues based on input from senior leadership & field leadership - Manage field alignment including field roster, zip to terr, HCO/HCP targeting and alignment and DCRs with input from field colleagues and analytics vendor. - Coordinate/manage sample operations and logistics with sampling vendor and field colleagues. - Work with fleet vendor to coordinate fleet operations and logistics along with field leadership. - Help train field colleagues on subnational data sources, reporting tools, CRM, sampling & fleet logistics - This role will report to Exec. Director of Business Analytics & CI. Skills and Attributes - Excel skills - Powerpoint presentation skills - Reporting Tools - Excellent interpersonal & communication skills required to work with and help train numerous cross functional colleagues - Veeva suite of commercial platforms (i.e. Veeva CRM, OpenData/Network). - Knowledge of incentive compensation plan design and administration Education and Experience - 10+ Years in Biotech / Pharmaceutical Industry - 3+ years experience in commercial operations or field training preferred - 3+ years field experience as a representative / 1L manager / medical science liaison is required - Experience managing multiple vendors (e.g CRM design, IC, sampling, fleet) and working relationships with relevant vendors is preferred - Experience working with many “internal customers” such as field teams is required - Demonstrated success in optimizing field force effectiveness by leveraging performance metrics and implementing deployment, alignment and targeting strategies. Travel - This position requires up to 15% travel. Frequently travel is outside the local area and overnight. US Salary Range: $180,000 - $245,000 #LI-Remote

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We are looking for a Director, Data Platform and Orchestration to inherit this foundation, own it end-to-end, and evolve it into a long-term strategic asset. This is not a greenfield role — the architectural direction has been set. What we need is someone with the depth to master what has been built, the judgment to evolve it thoughtfully, and the maturity to govern a framework that is foundational to how Mineralys runs its business. - Design and build Mineralys' data platform on Microsoft Fabric and Power BI, starting with commercial data use cases (sales performance, market access, patient analytics) and scaling progressively into R&D and broader enterprise needs. - Architect and implement a medallion framework (Bronze/Silver/Gold) for data ingestion, transformation, and consumption, ensuring data is reliable, traceable, and fit for purpose. - Identify and apply AI capabilities where they create meaningful value within the platform — accelerating pipeline development, improving data quality, or enabling smarter consumption — with the judgment to know where they don't. - Provide hands-on technical direction to a network of consultants and external contributors, staying actively engaged in the work — reviewing pipelines, validating data models, and making architectural calls in real time. - Co-own data governance frameworks alongside business stakeholders, embedding standards, definitions, and quality controls into the architecture from day one. - Partner with IT Infrastructure, Commercial, and R&D business units to capture requirements and validate solutions. - Contribute as an active member of the Technology Center of Excellence, bringing data platform expertise to broader technology strategy, and report progress, decisions, and risks clearly to the VP of IT and senior leadership. Qualifications - BS/MS in Computer Science, Engineering, or a related field — or equivalent professional experience. - 7 to 15 years of progressive experience in data engineering, data architecture, and business intelligence, with demonstrated growth in scope and complexity. - Hands-on, proven experience with Microsoft Fabric and Power BI — required. Familiarity with the broader Microsoft data ecosystem (Azure Data Factory, Synapse) is a plus. - Experience designing and implementing medallion architectures (Bronze/Silver/Gold) or equivalent data lake frameworks at enterprise scale. - Background in the pharmaceutical industry, with meaningful exposure to the commercial space — sales, market access, or patient analytics. - Familiarity with commercial pharma data sources (e.g., IQVIA, APLD, or similar) and use cases. - Experience supporting or contributing to a product launch is a significant plus. Requirements - Velocity – Drive Speed with Purpose - Data-Driven Decision Making – Ground Strategy in Evidence - Agile Mindset – Embrace Iteration and Change - Frictionless Execution – Simplify the Path to Results - Autonomy – Lead with Ownership and Accountability - Execution that Delivers Value Benefits - This position is eligible for standard Company benefits including medical, dental, vision, time off, and 401K. - Participating in Mineralys incentive plans are contingent on achievement of personal and company performance. - Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level. - US Salary Range: $190,000 - $220,000 Travel This position requires up to 10% travel. Frequently, travel is outside the local area and overnight. Some of the travel may be international.

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. Senior Director, Life Cycle Management (LCM) Program Management The Senior Director, Life Cycle Management (LCM) Program Management is a strategic leadership role responsible for governing and driving the end-to-end life cycle management strategy for the lorundrostat program. This leader partners closely with Clinical Development, Regulatory, CMC, Commercial, Medical Affairs, Finance, and Corporate Leadership to ensure that life cycle opportunities are prioritized, and executed. The Senior Director serves as the enterprise LCM orchestrator, translating Corporate strategy into integrated, executable life cycle plans, establishing fit-for‑-‑purpose governance, and enabling data-driven decision making at the GPT and Executive levels. This role requires comfort operating in ambiguity, influencing without authority, and balancing near-term execution with long-term value creation in a rapidly evolving setting. Principal Responsibilities - Serve as the Program Management Lead for life cycle initiatives, coordinating cross-functional teams across Clinical Development, Regulatory, CMC, Commercial, Medical Affairs, Market Access, Safety, Quality, and Operations. - Evaluate, and prioritize life cycle opportunities, risks, and trade-offs aligned with corporate strategy and value creation goals. - Drive alignment on objectives, scope, timelines, dependencies, and critical path activities across life cycle workstreams. - Facilitate and lead cross-functional forums, life cycle reviews, and governance discussions to enable timely, well-informed decision making. - Develop high-quality executive-level materials, dashboards, and decision frameworks that synthesize complex cross-functional inputs. Skills and Attributes - Collaborative leader who can align diverse stakeholders toward common goals - Strategic and systems thinking with a portfolio mindset - Executive presence and exceptional communication skills - Ability to translate strategy into actionable, integrated plans and pivot, re-evaluate as needed - Strong risk management, scenario planning, and problem-solving capabilities - Ability to work under time pressure and effectively in a team or matrix environment - Metrics-oriented, execution that delivers value and moves the business Education and Experience - Bachelor’s degree required; advanced degree (MBA, MS, MD, PhD) preferred. - Extensive experience in program and portfolio management within biopharmaceutical or life sciences organizations. - Demonstrated leadership across full product life cycle, including launch, and post approval optimization. - Proven ability to operate at the enterprise and executive level, influencing strategy and decisions across functions. - Strong track record of leading complex, cross-functional initiatives in fast paced, ambiguous environments. Travel - This position requires up to 10% travel. Frequently travel is outside the local area and overnight. Some of the travel may be international. Position eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level. US Salary Range: $225,000 - $250,000 #LI-Remote

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. As a key member of the Market Access leadership team, The Senior Director, Pricing and Contracting is a critical strategic and operational role responsible for developing and executing Mineralys' contracting and pricing strategy as the company approaches its first commercial product launch. This individual will serve as the company's subject matter expert on all aspects of pricing, contracting, gross-to-net (GTN) management, pricing reporting systems and government pricing compliance, and will play a central role in ensuring that Mineralys achieves strong market access and revenue optimization at launch. The Senior Director will lead contract development and negotiation across a broad range of customer segments while also overseeing the company's government pricing program and serving as a key member of the Pricing Governance Committee. This individual will work closely with senior leadership, Market Access, Commercial, Finance, Trade and Distribution, Legal, and Patient Services. Key Responsibilities Pricing Strategy and Governance - Serve as a core member of the Pricing Governance Committee, partnering with the SVP, Market Access, CFO, and senior leadership to evaluate and approve pricing decisions, rebate strategies, and contract terms for key customers. - Lead ongoing competitive pricing analysis and market intelligence, monitoring competitor pricing, payer dynamics, and industry trends to inform Mineralys' pricing strategy and enable proactive responses to market developments. - Develop and maintain GTN forecasting models in collaboration with Finance; ensure accurate accrual estimates and provide regular reporting to support financial planning and compliance. - Assess and advise senior leadership on the benefit/risk implications of complex pricing and contracting decisions, highlighting customer impacts, policy risks, and operational considerations. Contract Development and Negotiation - Develop contract templates, standard language, and contracting frameworks for all customer segments, including GPOs, PBMs, health plans andmanaged Medicaid, - Negotiate and execute market access agreements with key customers, managing the full contract lifecycle from initial bid through execution, ensuring terms protect the organization from unintended liabilities and align with business objectives. - Work closely with Market Access account executives to support bids and customer negotiations, providing pricing and contract expertise while maintaining appropriate internal firewall protocols. - Ensure all contracts are aligned with strategic business objectives, relevant regulations, and internal policies; manage contract compliance and identify and address revenue leakage. - Support the RFP and selection process for specialty pharmacies and distributors in partnership with the Trade and Distribution team. Government Pricing and Compliance - Oversee all government pricing obligations, including AMP, Best Price, ASP, and Medicaid rebate calculations, ensuring accurate and timely reporting in compliance with applicable federal and state regulations. - Manage the company's relationship with its government pricing vendor (Integrichain), overseeing program setup, ongoing operations, audit readiness, and compliance with all reporting obligations. - Assess all administrative and service fees for bona fide service requirements and fair market value to ensure appropriate treatment in government pricing calculations. - Stay current on evolving government regulations, legal rulings, and industry guidance; advise leadership on implications for contractual and reporting obligations. Cross-Functional Collaboration and Operations - Partner cross-functionally with Market Access, Commercial, Finance, Legal, Trade and Distribution,, and senior leadership to align contracting strategy with corporate objectives. - Streamline contracting and pricing operations; develop and maintain policies, procedures, and decision frameworks to support scalable, compliant, and efficient processes. - Support analytics related to contract performance, GTN variances, and pricing trends; translate data into actionable insights for leadership. - Contribute to launch readiness planning, ensuring all contracting, pricing, and government pricing infrastructure is in place prior to commercial launch. Qualifications - 10+ years of progressive experience in pharmaceutical pricing and contracting, with substantial experience in a senior individual contributor or director-level role. - Deep expertise across the full contracting lifecycle with payers, GPOs,PBMs and Health plans.. - Hands-on government pricing experience, including AMP, Best Price, ASP, and Medicaid rebate calculations, and familiarity with relevant federal and state compliance requirements. - Strong GTN modeling and forecasting capabilities; experience collaborating with Finance on accruals and financial reporting. - Demonstrated ability to develop contract strategy, negotiate with major payers and PBMs,. - Proven ability to operate effectively in a small company environment, managing both strategic direction and hands-on execution. - Bachelor's degree required. Travel - This position requires up to 20% travel. Frequently travel is outside the local area and overnight. Some of the travel may be international. Position eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level. US Salary Range: $245,000 - $260,000 #LI-Remote

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. As a key member of the Market Access leadership team, The Senior Director, Pricing and Contracting is a critical strategic and operational role responsible for developing and executing Mineralys' contracting and pricing strategy as the company approaches its first commercial product launch. This individual will serve as the company's subject matter expert on all aspects of pricing, contracting, gross-to-net (GTN) management, pricing reporting systems and government pricing compliance, and will play a central role in ensuring that Mineralys achieves strong market access and revenue optimization at launch. The Senior Director will lead contract development and negotiation across a broad range of customer segments while also overseeing the company's government pricing program and serving as a key member of the Pricing Governance Committee. This individual will work closely with senior leadership, Market Access, Commercial, Finance, Trade and Distribution, Legal, and Patient Services. Key Responsibilities Pricing Strategy and Governance - Serve as a core member of the Pricing Governance Committee, partnering with the SVP, Market Access, CFO, and senior leadership to evaluate and approve pricing decisions, rebate strategies, and contract terms for key customers. - Lead ongoing competitive pricing analysis and market intelligence, monitoring competitor pricing, payer dynamics, and industry trends to inform Mineralys' pricing strategy and enable proactive responses to market developments. - Develop and maintain GTN forecasting models in collaboration with Finance; ensure accurate accrual estimates and provide regular reporting to support financial planning and compliance. - Assess and advise senior leadership on the benefit/risk implications of complex pricing and contracting decisions, highlighting customer impacts, policy risks, and operational considerations. Contract Development and Negotiation - Develop contract templates, standard language, and contracting frameworks for all customer segments, including GPOs, PBMs, health plans andmanaged Medicaid, - Negotiate and execute market access agreements with key customers, managing the full contract lifecycle from initial bid through execution, ensuring terms protect the organization from unintended liabilities and align with business objectives. - Work closely with Market Access account executives to support bids and customer negotiations, providing pricing and contract expertise while maintaining appropriate internal firewall protocols. - Ensure all contracts are aligned with strategic business objectives, relevant regulations, and internal policies; manage contract compliance and identify and address revenue leakage. - Support the RFP and selection process for specialty pharmacies and distributors in partnership with the Trade and Distribution team. Government Pricing and Compliance - Oversee all government pricing obligations, including AMP, Best Price, ASP, and Medicaid rebate calculations, ensuring accurate and timely reporting in compliance with applicable federal and state regulations. - Manage the company's relationship with its government pricing vendor (Integrichain), overseeing program setup, ongoing operations, audit readiness, and compliance with all reporting obligations. - Assess all administrative and service fees for bona fide service requirements and fair market value to ensure appropriate treatment in government pricing calculations. - Stay current on evolving government regulations, legal rulings, and industry guidance; advise leadership on implications for contractual and reporting obligations. Cross-Functional Collaboration and Operations - Partner cross-functionally with Market Access, Commercial, Finance, Legal, Trade and Distribution,, and senior leadership to align contracting strategy with corporate objectives. - Streamline contracting and pricing operations; develop and maintain policies, procedures, and decision frameworks to support scalable, compliant, and efficient processes. - Support analytics related to contract performance, GTN variances, and pricing trends; translate data into actionable insights for leadership. - Contribute to launch readiness planning, ensuring all contracting, pricing, and government pricing infrastructure is in place prior to commercial launch. Qualifications - 10+ years of progressive experience in pharmaceutical pricing and contracting, with substantial experience in a senior individual contributor or director-level role. - Deep expertise across the full contracting lifecycle with payers, GPOs,PBMs and Health plans.. - Hands-on government pricing experience, including AMP, Best Price, ASP, and Medicaid rebate calculations, and familiarity with relevant federal and state compliance requirements. - Strong GTN modeling and forecasting capabilities; experience collaborating with Finance on accruals and financial reporting. - Demonstrated ability to develop contract strategy, negotiate with major payers and PBMs,. - Proven ability to operate effectively in a small company environment, managing both strategic direction and hands-on execution. - Bachelor's degree required. Travel - This position requires up to 20% travel. Frequently travel is outside the local area and overnight. Some of the travel may be international. Position eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level. US Salary Range: $245,000 - $260,000 #LI-Remote

The Senior Director, Head of Regulatory Operations & Compliance, is a key leadership role within Regulatory Affairs, accountable for the regulatory submission excellence and compliance framework across the product lifecycle. Owns global submission execution, regulatory systems governance (RIM/publishing), and the RA compliance program and inspection readiness. Partners closely with Regulatory Strategy, QA, Clinical, CMC, and Medical Writing to deliver high-quality submissions and to maintain compliant, controlled processes and systems. Key Responsibilities Submission Management: Set submission strategy and operational timelines in partnership with Regulatory Strategy and the cross‑functional teams. Lead the operational planning and execution of global regulatory submissions (INDs/CTAs, NDAs/MAAs, post‑approval lifecycle submissions, HA interactions). Oversee submission formatting, publishing, QC and archival in accordance with global standards. Set submission strategy and operational timelines in partnership with Regulatory Strategy and the cross‑functional teams. Lead the operational planning and execution of global regulatory submissions (INDs/CTAs, NDAs/MAAs, post‑approval lifecycle submissions, HA interactions). Oversee submission formatting, publishing, QC and archival in accordance with global standards. Process & Systems: Build, evolve, and manage the Regulatory Operations infrastructure, including processes, standards, templates, and best practices. Own and optimize regulatory systems (RIM, publishing tools, controlled document systems), driving automation and efficiency. Partner with IT, QA, and system vendors to ensure appropriate lifecycle control for regulated systems. Build, evolve, and manage the Regulatory Operations infrastructure, including processes, standards, templates, and best practices. Own and optimize regulatory systems (RIM, publishing tools, controlled document systems), driving automation and efficiency. Partner with IT, QA, and system vendors to ensure appropriate lifecycle control for regulated systems. Compliance & Inspection Readiness: Maintain submission metrics and compliance tracking, including periodic reviews of archives, submission history, and audit trails. Lead the creation, implementation, and maintenance of RA SOPs, Work Instructions, and templates to ensure standardization and inspection readiness. Establish and oversee training on RA procedures and submission standards. Support inspections/audits, and partner with QA to address inspection findings, ensuring continuous improvement in alignment with quality system principles. Maintain submission metrics and compliance tracking, including periodic reviews of archives, submission history, and audit trails. Lead the creation, implementation, and maintenance of RA SOPs, Work Instructions, and templates to ensure standardization and inspection readiness. Establish and oversee training on RA procedures and submission standards. Support inspections/audits, and partner with QA to address inspection findings, ensuring continuous improvement in alignment with quality system principles. Team & Vendor Management: Build and lead a high‑performing regulatory operations team, oversee submission operating model and resource planning. Manage external vendors (publishing partners, systems providers, CROs) to ensure quality and performance aligned with company expectations. Build and lead a high‑performing regulatory operations team, oversee submission operating model and resource planning. Manage external vendors (publishing partners, systems providers, CROs) to ensure quality and performance aligned with company expectations. Cross-Functional Partnership: Partner with Regulatory Strategy to ensure alignment of operational plans. Serve as a key liaison with CMC, Clinical, PV, and Medical Writing to ensure efficient preparation of submission‑ready content. Collaborate closely with QA on procedural governance and RA‑related training. Partner with Regulatory Strategy to ensure alignment of operational plans. Serve as a key liaison with CMC, Clinical, PV, and Medical Writing to ensure efficient preparation of submission‑ready content. Collaborate closely with QA on procedural governance and RA‑related training.