MDWerks Inc.

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

Director

• 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

Marketing

• 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

Director, HCP Marketing, Thought Leader Engagement

• Leading the development, execution, and maintenance of global CMC regulatory strategy to support clinical development, registration, commercialization and lifecycle management of Mineralys products.
• Providing strategic and operational leadership for all CMC-related regulatory activities.
• Supporting cross-functional decision-making by providing regulatory guidance.
• Ensuring compliance of CMC documentation and high-quality submissions that meet global regulatory requirements and support business objectives.
• Partnering closely with CMC, Quality, and external partners to ensure alignment of CMC documentation, regulatory strategy, product lifecycle planning and management.

Senior Director, CMC Regulatory Affairs

• Lead all regulatory activities related to medical and promotional material development, review, and external communications for Mineralys as it advances toward commercialization.
• Serve as the primary regulatory representative on the Medical, Legal and Regulatory (MLR) team, ensuring that all promotional, non-promotional and scientific exchange materials adhere to internal policies, relevant laws, FDA regulations, and industry standards.
• Provide timely, compliant strategic guidance for all promotional and non-promotional materials development.
• Interpret and apply FDA Advertising & Promotion regulations, guidance, OPDP expectations and enforcement trends, to company materials.
• Serve as a strategic thought partner with Marketing and Medical Affairs to develop compliant and compelling promotional and medical strategy and framework ahead of launch.
• Collaborate cross-functionally with Medical Affairs, Commercial, Legal, Clinical Development, and agency partners on messaging and claims substantiation.
• Provide regulatory guidance on digital and omnichannel content, including modular content, rapid update scenarios, and social media platforms.
• Review all relevant materials, including but not limited to digital and print assets, HCP and patient-facing materials, disease awareness, sales training, company-controlled medical education, press releases, social media, and investor communications (as appropriate) to ensure compliance.
• Partner with Marketing Operations to ensure seamless MLR execution, workflow design, SOPs, timelines, and cross-functional coordination.
• Lead interactions with OPDP, including advisory comments, submissions, and correspondence.
• Orchestrate promotional audits and monitoring, and corrective actions as appropriate.
• Monitor and interpret regulatory developments related to Advertising & Promotion and proactively update the organization regarding implications.
• Support internal training on Advertising & Promotion requirements.
• Build strong relationships across Medical, Legal, Commercial, Clinical, and Compliance functions, providing balanced solutions-oriented guidance.
• Facilitate discussions around regulatory risk tolerance and best practices to enable compliant and competitive brand execution.

Senior Director, Advertising and Promotion – Regulatory Affairs

• Provide operational support for the Field Medical team, including coordination of equipment, company vehicles, onboarding, offboarding, and resource management.
• Lead onboarding, training, and ongoing education processes for Medical Science Liaisons to ensure consistent readiness, compliance, and scientific alignment.
• Track, coordinate, and maintain documentation for Investigator-Initiated Studies (IIS), ensuring compliance with internal procedures and external regulations.
• Serve as the primary liaison with IT, ensuring efficient communication, troubleshooting, and support for all Medical team members.
• Manage and optimize medical systems—including Veeva, data repositories, reporting tools, and documentation platforms—to support accuracy, compliance, and operational scalability.
• Build and maintain infrastructure for medical activities, including publication planning systems, insights management, and scientific engagement tracking.
• Develop, implement, and maintain SOPs and operational processes related to contract management for HCP engagements, vendors, and service providers.
• Coordinate Fair Market Value (FMV) assessments and ensure documentation is compliant with internal guidelines.
• Support creation of 1-year and 5-year operational plans for the Medical Affairs function, including resource planning, systems roadmaps, and capability development.
• Establish and track Key Performance Indicators (KPIs) to measure Medical Affairs effectiveness, field performance, insights generation, scientific engagement, operational efficiency, and compliance adherence.
• Streamline processes for advisory boards, medical symposia, congress activities, and scientific meetings—including logistics, vendor coordination, contracting, compliance workflow, and post-event deliverables.
• Work closely with Clinical Development, Commercial, IT, Legal, and Compliance to ensure alignment, transparency, and continuous improvement across all Medical operations.

Director/Sr. Director, Medical Excellence Operations

• Lead the strategic design, implementation, and oversight of patient access and healthcare provider (HCP) support programs for a cardiovascular therapy.
• Ensure patients can access and afford their prescribed treatment while enabling HCPs to navigate reimbursement and administrative processes efficiently.
• Provide leadership to the Field Reimbursement Management organization with direct reports to this position.
• Develop, execute, and manage patient support programs.
• Analyze financial barriers to access and implement strategies to mitigate these challenges.
• Collaborate with cross-functional teams to ensure affordability solutions align with brand strategy and compliance standards.
• Develop, execute, and manage patient support services for HCPs with reimbursement issues.
• Ensure seamless integration of support services into HCP workflows to reduce administrative burden and improve patient outcomes.
• Assess and develop optimal channel strategy.
• Select, contract, and manage third-party vendors to deliver high-quality patient and HCP support services.
• Assist with the implementation of new services, program enhancements and operational efficiencies.
• Negotiate viable contracts within established budget parameters.
• Identify customer, access and program performance trends that need to be escalated and followed through to resolution.
• Monitor vendor performance and ensure compliance with regulatory and legal requirements.
• Work closely with the commercial leadership team to develop overall strategy, objectives, and key performance indicators for patient services, aligning with the trade distribution network.
• Lead cross-functional governance to oversee program operations and continuous improvement.
• Manage FRM teams’ daily activities that support patient and HCP reimbursement.
• Provide general education on Retail and Specialty Pharmacy drug Prior Authorizations, Appeals, and Denials.
• Establish team priorities and KPIs to ensure company strategic objectives are on target.
• Develop and monitor initial and ongoing training activities for FRM teams.
• Serve as a strategic payer expert across national territories and communicate payer changes to key stakeholders in a timely manner.

Senior Director – HCP and Patient Support Services

Procurement

• Develop and execute outsourcing strategies for clinical trials in collaboration with Clinical Development.
• Lead RFI/RFP processes, vendor evaluations, and bid defense meetings.
• Ensure all outsourcing activities conform to compliance standards.
• Negotiate Master Service Agreements (MSAs) and work orders.
• Work cross-functionally to identify and manage special project initiatives.
• Drive standardization and process improvement across vendors.
• Oversee vendor performance through KPIs and governance meetings.
• Collaborate with internal team members to manage vendor relationships.
• Partner with Finance to forecast study budgets and manage financial accruals.
• Train and educate clinical development and other relevant functional areas.

Associate Director, Vendor Management

• Serve as a primary field-based scientific subject matter expert supporting Medical Affairs and Market Access, providing therapeutic area, clinical, economic and product expertise.
• Build, cultivate, and enhance professional relationships with key payor and population health decision makers across regions and geographies.
• Provide scientific and clinical support to the Market Access team in alignment with strategic medical and corporate objectives.
• Engage in evidence-based clinical and economic discussions with payor stakeholders, including formulary decision makers, medical directors, and pharmacy directors.
• Develop a tactical, customer-centric medical engagement plan aligned with leadership direction.
• Provide timely, accurate clinical, scientific, and economic updates—proactively or in response to unsolicited requests—per SOP, including support related to value dossiers and evidence materials.
• Demonstrate strong knowledge of value evidence and how payors utilize clinical, economic, and humanistic evidence in access, reimbursement, and adoption decisions.
• Contribute to the development of value evidence generation plans, ensuring alignment with evolving payer needs.
• Identify real-world evidence (RWE) opportunities based on payer insights and communicate these opportunities to internal cross-functional teams.
• Provide medical support at selected scientific congresses, including attending sessions, supporting the medical information booth, conducting debriefs, and preparing post-congress summaries for internal stakeholders.
• Gather, interpret, and communicate key customer insights to inform internal strategy, evidence development, and product planning.
• Ensure all activities comply with company policies, procedures, and applicable regulations (e.g., FDA, OIG, OSHA, PhRMA, etc.).

Director, Medical Value & Outcomes

Medical Director

• Directly manage, coach, and mentor a team of MSLs within an assigned region, providing ongoing performance feedback, development planning, and field coaching to enhance scientific acumen, engagement quality, and professional growth
• Recruit, onboard, develop, and retain a high-performing team of MSLs, fostering a culture of scientific rigor, accountability, collaboration, and continuous improvement
• Ensure consistent execution of MSL core responsibilities, scientific engagement standards, and compliance expectations across the region
• Establish clear performance expectations and development plans aligned with medical strategy and organizational priorities
• Partner with Medical Affairs leadership and Director, Field Medical Training to support MSL onboarding, training, and ongoing professional development
• Conduct regular field rides, virtual touchpoints, and performance reviews to assess effectiveness and alignment with Medical Affairs objectives
• Foster an inclusive, collaborative, and high-performance team culture
• Translate Medical Affairs strategy into clear, actionable objectives, field medical plans, and execution of priorities aligned with company objectives
• Ensure regional MSL activities support disease-state education, scientific exchange, and clinical data dissemination in cardiovascular, renal, and metabolic disease areas
• Ensure consistent, accurate, and compliant scientific messaging across all field activities through field observation
• Support MSL participation in medical congresses, advisory boards, investigator meetings, speaker training, and other scientific forums
• Monitor and optimize regional coverage plans, KOL and regional payer engagement strategies, and field medical priorities
• Oversee regional KOL identification, profiling, and engagement strategies across academic and community settings
• Maintain in-depth knowledge of relevant therapeutic areas, disease states, and competitive landscape to support high-quality scientific exchange
• Ensure high-quality, compliant scientific interactions with HCPs, thought leaders, and regional payers
• Serve as an escalation point for complex scientific discussions and high-priority stakeholder engagements when appropriate
• Support regional insights generation related to disease management trends, unmet needs, and competitive intelligence
• Act as a strategic partner to internal cross-functional teams to align on priorities including Medical Affairs, Clinical Development, Regulatory, Commercial, and Market Access
• Ensure timely communication of field medical insights to inform clinical strategy, medical planning, and future launch readiness
• Collaborate with clinical teams to support site engagement, investigator-sponsored research opportunities, and trial support activities with Clinical Development as needed
• Provide input into regional resource planning, budgeting, and operational priorities
• Support medical launch readiness and execution for new indications or assets, as applicable
• Ensure all regional field activities are conducted in compliance with company SOPs and applicable regulations (FDA, PhRMA, PDMA, etc.)
• Establish and monitor key performance indicators (KPIs) to assess scientific engagement quality, impact, and operational effectiveness
• Oversee accurate and timely documentation of field activities, insights, and metrics in required systems
• Contribute to development and refinement of MSL SOPs/guidance, metrics, and reporting processes
• Promote best practices, standardization, and continuous improvement across all field medical

Regional Field Medical Director – Cardiovascular

Human Resources

• Facilitate new employee experience from offer letter to onboarding and orientation, ensuring completion of required documentation and smooth integration into company culture.
• Coordinate and update organizational charts to reflect staffing changes and departmental structures.
• Oversee, manage, and continuously improve HR systems and processes, including maintaining accurate employee records and data integrity.
• Support health, wellness, and people operations initiatives to foster employee well-being and engagement.
• Assist with employee offboarding, including exit interviews, final paperwork, and coordination with relevant departments.
• Serve as a key liaison between HR and other departments such as finance, administration, quality, IT, and functional leads to facilitate communication and drive process improvements.
• Respond to employee inquiries related to HR policies, benefits, and compensation, providing timely and accurate information.
• Support the development and delivery of training programs and professional development initiatives for staff.
• Assist in the preparation of HR reports and metrics for management review.
• Coordinate employee recognition and engagement programs to foster a positive workplace culture.