MDWerks Inc.

Director

• Lead the development and execution of the Commercial GMP Quality strategy aligned with corporate objectives and regulatory expectations.
• Serve as the primary GMP Quality leader for commercial manufacturing activities.
• Partner with cross-functional leadership to support product launches, tech transfers, and lifecycle management initiatives.
• Oversee the design, implementation, and governance of robust GMP Quality Systems.
• Ensure continued inspection readiness across all GMP operations.
• Provide final Quality review and disposition of commercial drug product and drug substance.
• Ensure compliant and efficient review of master and executed batch records.
• Serve as the senior quality representative for GMP contract manufacturers (CMOs).
• Lead GMP-related inspections and audits and manage responses.

Senior Director, Commercial GMP Quality

• 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

Associate Director – Director, Biostatistics

Marketing

• 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
• 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
• 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
• 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

Senior Director, Global Marketing

Human Resources

• 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
• 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
• 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
• 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
• 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

Director – Human Resources, Commercial

• 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

Associate Director, Drug Product Development – Manufacturing

• 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.

Director, Data Platform and Orchestration

Program Manager

• 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.

Senior Director, LCM Program Management

• 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.
• Develop contract templates, standard language, and contracting frameworks for all customer segments, including GPOs, PBMs, health plans and managed 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.
• 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.
• 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.
• Stay current on evolving government regulations, legal rulings, and industry guidance; advise leadership on implications for contractual and reporting obligations.
• 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.

Senior Director, Pricing and Contracting

• Own the development and execution of HCP brand strategy grounded in deep understanding of clinical data, existing standards of care, treatment guidelines, and competitive dynamics.
• Translate strategic insights including segmentation, decision drivers, and prescribing behaviors into launch readiness plans and prioritized HCP engagement tactics.
• Lead development and execution of positioning, messaging and creative, as well as integrated HCP campaigns, including personal and non-personal channels
• Serve as a core member of launch leadership teams ensuring alignment of brand and HCP strategy across functions.
• Partner closely with the Patient & Consumer Marketing lead and Digital team to deliver aligned omnichannel strategy and integrated activation across HCP, patient, and digital touchpoints.
• Actively partner with Sales, Sales Training, and Commercial Operations to develop and optimize field force initiatives.
• Work closely with Medical, Legal, Regulatory, and Compliance to ensure compliant and aligned messaging and execution.
• Collaborate closely with Medical Affairs to integrate clinical data and real-world experience into HCP brand strategy and ensure aligned evidence generation planning
• Establish performance indicators to assess and optimize launch performance and promotional effectiveness.
• Develop and manage relationships with external vendors and agency partners
• Manage HCP marketing budget and resource allocation

Director – HCP Marketing

Compliance

• 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.
• 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.
• 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.
• 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.
• 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.

Senior Director – Head of Regulatory Operations, Compliance

Digital Marketing

• Develop and execute digital and omnichannel strategy aligned with customer needs, brand objectives, and launch goals.
• Evaluate, select, and operationalize CRM, marketing automation, analytics platforms, content management systems (CMS), digital asset management (DAM), consent management, and reporting tools in partnership with IT and agency partners.
• Oversee owned, earned, and paid digital ecosystem (websites, CRM, email, paid media, SEO/SEM, social, programmatic) to ensure channel integration and continuous performance optimization.
• Establish digital standards, operating models and processes that scale with the organization.
• Monitor emerging digital trends and technologies to identify opportunities for enhanced customer engagement through AI, digital health tools, telehealth integrations, and new channels.
• Establish UX/UI standards across all digital properties, ensuring intuitive navigation, accessibility compliance, and consistent brand experience.
• Lead digital media planning and optimization, collaborating with agency partners to refine audience strategies, channel mix, and activation plans.
• Build audience targeting, segmentation, and personalization strategies leveraging 1P (first‑party) and 3P (third‑party) data through healthcare data partnerships and privacy-safe activation methods.
• Design personalized, insight-driven content strategies and modular assets to support omnichannel engagement across HCP and patient journeys in collaboration with HCP and Consumer Brand Leads.
• Own digital and omnichannel budgets, including scenario planning, investment allocation, forecasting, and ROI measurement.
• Map end‑to‑end HCP and patient journeys, identifying key moments, triggers, and channel opportunities.
• Design digital–field orchestration including CLM content, rep‑triggered email, automated nurture sequences, behavioral triggers, next‑best‑action logic, field alerts, and closed‑loop reporting—ensuring seamless data flows between CRM, marketing automation, web, and analytics.
• Integrate digital touchpoints with field activities, patient support services, and brand objectives to deliver a seamless, personalized experience.
• Develop digital tools, training, and processes to enable Field Sales and MSLs as integrated touchpoints in the customer journey.
• Partner with IT, Analytics, and agency partners to ensure strong technical integration and visibility across the customer journey.
• Drive development of KPIs, dashboards and measurement frameworks; define leading/lagging indicators for launch.
• Lead a robust test‑and‑learn agenda to continuously optimize channel performance and budget allocation.
• Translate data into actionable insights and next‑step recommendations that inform brand strategy and commercial planning.
• Build and oversee the vendor/agency ecosystem required for launch success; define scopes, operating cadences, and quality benchmarks.
• Embed digital best practices and a culture of omnichannel thinking across the commercial organization.
• Serve as a strategic partner to the field teams, ensuring omnichannel insights and digital resources support field effectiveness.
• Ensure all digital programs and content adhere to FDA guidelines, privacy laws (e.g., HIPAA), data governance principles, and internal policies.
• Lead consent management and privacy-compliant data strategies that future-proof targeting capabilities amid evolving privacy regulations.
• This position requires up to 20-30 % travel. Frequently travel is outside the local area and overnight. Some of the travel may be international.

Director, Omnichannel and Digital Marketing

Operations

• Serve as primary operational lead and chair for both PRC (promotional) and MRC (medical) workflows.
• Partner with the Head of Regulatory Ad Promo to design workflows, cadence, SOPs, and quality controls for both promotional and medical review.
• Coordinate reviewers, manage agendas, track decisions, and ensure timely, high quality reviews, and coordination of 2253 submissions.
• Align on reviewer expectations, timing, prioritization, and cross functional readiness.
• Coordinate and support issue escalation and risk mitigation discussions for promotional and medical claims.
• Oversee all routing, issue tracking, meeting facilitation, and documentation within Veeva PromoMats as well as system and software updates.
• Reviews submissions for accuracy and compliance with SOPs and facilitates/moderates reviews.
• Provides expert guidance and training to promotional material sponsors and agencies on submission of high-quality and compliant work, review cycle timelines, and planning for submission through review to approval.
• Oversee development-to-distribution workflows for all approved print and digital materials.
• Manage vendor relationships covering production, inventory, storage, ordering, and distribution.
• Lead quality assurance, version control, and compliance-driven lifecycle management.
• Work closely with marketing and field sales to ensure the field and customer-facing teams have timely, compliant materials.
• Build and maintain scalable SOPs, workflows, templates and governance frameworks.
• Enhance operational efficiency through continual evaluation and optimization of process, systems, and vendor models.
• Partner with Digital/Omnichannel, Sales Ops, and IT to ensure future integration across CRM, consent, data flows, and digital ecosystem.
• Own operations budget spanning PRC/MRC operations, production, and fulfillment.
• Own system configuration and administration for promotional material review and approval platforms.
• Manage forecasting, tracking, and PO processes with discipline and transparency.
• This position requires up to 10-20% travel. Frequently travel is outside the local area and overnight. Some of the travel may be international.

Director, Marketing Capabilities – Operations

• Develop and launched a comprehensive Promotional Medical Education platform encompassing a Congress Strategy, Speakers Bureau, National Broadcasts, and Third-Party Educational Content for both pre-launch unbranded and branded initiatives
• Lead strategy, design, and execution of national and regional advisory boards, aligning to evidence gaps and shaping scientific narrative.
• Develop a structured KOL engagement roadmap across pre‑ and post‑approval phases and foster relationships with national and regional thought leaders in hypertension and CVRM care
• Build Mineralys’ first speaker bureau including recruitment, evaluation, training, content development, and performance monitoring
• Develop and execute industry leading non-personal promotional medical educational programs
• Lead commercial efforts to provide strategic insight into unmet needs, real‑world gaps, and future opportunity areas into clinical development and investment decisions to ensure commercially competitive clinical profiles for LCM planning
• Work cross‑functionally to pressure‑test potential LCM scenarios and support evidence‑generation prioritization.
• Collaborate cross-functionally to build processes and ensure compliance in HCP contracting, fair‑market‑value adherence, Sunshine Act reporting, promotional content review, and program execution