MDWerks Inc.

Communications

• Lead the strategy and execution of scientific communications, medical information, and publication planning in support of the company’s pipeline and eventual commercial launch
• Partner cross-functionally with Medical Affairs, Clinical Development, Regulatory, and Commercial teams to deliver impactful and timely scientific exchange aligned with corporate and program objectives
• Lead the development of disease-state and product-specific materials in collaboration with vendors and internal stakeholders
• Drive the omni-channel scientific communications strategy in alignment with Medical Affairs and corporate objectives
• Develop and implement publication plans to support scientific visibility and credibility
• Oversee the development of standard and custom responses to unsolicited requests, ensuring all content is scientifically accurate, balanced, and compliant
• Lead publication strategy and execution for clinical and nonclinical data, including manuscripts, abstracts, posters, and presentations

Senior Director, Scientific Communications

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, providing direction and oversight for internal teams and external partners
• Partner with cross-functional leadership to support product launches, tech transfers, and lifecycle management initiatives
• Oversee design, implementation, and governance of GMP Quality Systems (deviations, CAPAs, change control, batch record review, product disposition, quality metrics)
• Ensure continued inspection readiness across all GMP operations with proactive risk management and mitigation strategies
• Provide final Quality review and disposition of commercial drug product and drug substance, ensuring timely release
• Ensure compliant and efficient review of master and executed batch records, including investigation resolution and traceability documentation
• Serve as the senior quality representative for GMP contract manufacturers (CMOs), testing labs, and other service providers
• Oversee quality agreements, external audits, and performance monitoring for third-party vendors
• Lead GMP-related inspections and audits (FDA, EMA), manage responses and follow-up actions
• Direct internal and external audit programs, risk-based audit planning, execution, and CAPA closure
• Foster a proactive quality culture focused on continuous improvement, right-first-time execution, and operational excellence
• Leverage data and quality metrics to drive decision-making and promote transparency with senior leadership
• Position requires up to 25% travel, including occasional international trips

Senior Director, Commercial GMP Quality

Marketing

• Reporting to the VP of Marketing, the Director, Consumer and Patient Marketing will be responsible for defining and implementing consumer and patient brand strategy to drive brand awareness and shape a positive patient experience. This position will play a critical role in the launch success through creative and impactful DTC/DTP initiatives. This role is perfect for someone who thrives in an entrepreneurial setting and is excited to shape a brand from day one.
• Principal Responsibilities
• Define the consumer and patient brand strategy, including patient journey, positioning, segmentation, and messaging
• Partner with market research to identify actionable patient insights to drive innovation and ideation in DTC and DTP strategies.
• Lead creative and digital agencies to develop out of the box, high-impact, multichannel consumer and patient campaigns.
• Oversee the development of unbranded and branded patient education materials, support programs, and engagement tools.
• Collaborate with Market Access to design innovative patient support programs to support patient onboarding, adherence, and retention.
• Work closely with internal teams (Medical, Legal, Regulatory, Compliance) to ensure compliant and aligned messaging
• Evaluate the effectiveness of promotional strategies through campaign measurement and metrics development to ensure positive return on investment and achievement of brand objectives.

Director, Consumer and Patient Marketing

• Lead the development of HCP brand strategy and activation, including positioning, messaging, and tactical plans.
• Oversee creation and execution of a compelling creative campaign and HCP promotional assets.
• Partner on HCP focused market research efforts to ensure decisions are well-informed and driven by customer insights to accelerate brand growth and engagement.
• Serve as the brand lead and primary point person for launch planning, ensuring cross-functional alignment and aligned launch metrics.
• Work closely with internal teams (Medical, Legal, Regulatory, Compliance) to ensure compliant and aligned messaging
• Manage relationships with external vendors and agency partners
• Partner with Sales, Sales Training, and Commercial Operations to develop and optimize field force initiatives to support brand messaging and engagement.
• Evaluate the effectiveness of promotional strategies through campaign measurement and metrics development to ensure positive return on investment and achievement of brand objectives.

Director / Senior Director, HCP Marketing

• Mineralys Therapeutics is a clinical-stage biotechnology company developing lorundrostat, an aldosterone synthase inhibitor for cardiorenal conditions
• Lead creation of a data-driven value proposition tailored to payer and policy stakeholders
• Collaborate with Medical Affairs, HEOR, and Clinical teams to align messaging with product profile and unmet need
• Develop payer-facing materials including AMCP dossiers, PIE, and value decks
• Identify evidence gaps and prioritize evidence needs to support access and reimbursement goals
• Partner with HEOR and RWE teams to guide development of economic models, burden-of-illness studies, and comparative effectiveness research
• Develop pricing scenarios and recommendations and design innovative contracting approaches including value-based agreements
• Serve as the internal market access lead for the cardiovascular launch team and provide strategic input to Commercial, Medical, Regulatory, and Finance teams
• Monitor reimbursement policies, HTA trends, and payer expectations and translate external insights into actionable internal strategies

Senior Director, Scientific Communications

Senior Director, Commercial GMP Quality

Director, Consumer and Patient Marketing

Director / Senior Director, HCP Marketing

Director, Market Access