MDWerks Inc.

Director

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

Executive Director, Clinical Development

Marketing

• Provide high-level administrative support to the VP of Marketing, including meeting coordination, travel arrangements, and expense reporting
• Act as a trusted administrative partner, managing priorities, anticipating needs, and ensuring the VP of Marketing is prepared for internal and external meetings
• Coordinate meeting logistics, agendas, materials, and follow-ups for leadership, agency, and cross-functional marketing meetings
• Support development and refinement of presentations, pre-reads, and executive-ready materials
• Coordinate CDAs, consulting agreements, SOWs, POs in partnership with Legal and Finance
• Handle confidential and sensitive information with professionalism, discretion, and sound judgment
• Serve as a marketing coordinator supporting the planning and execution of marketing initiatives and key deliverables
• Partner with Finance to support brand budget tracking, invoice processing, and spend visibility
• Assist with the organization and maintenance of marketing assets, templates, and files (e.g., SharePoint or other content management tools)
• Coordinate with external agencies, vendors, and consultants to support marketing programs and initiatives
• Support logistics and execution for commercial meetings, internal communications, and cross-functional updates
• Help plan and execute engaging, well-organized Marketing and cross-functional team update meetings that build alignment, momentum, and connection
• Serve as a key administrative and operational user for Marketing systems and tools (e.g., SharePoint, project tracking tools, or content platforms as applicable)
• Support onboarding and training logistics for new Marketing team members
• Help establish and maintain organized, scalable processes to support a growing Marketing organization
• Act as a flexible resource across Marketing projects as priorities evolve

Marketing Coordinator

Compliance

• Serve as the primary legal advisor to the Commercial and Medical Affairs teams
• Provide strategic counsel across pre-launch and launch activities, balancing legal risk with business objectives
• Support commercialization readiness, including promotional strategy, market access, patient services, and distribution models
• Draft, review, and negotiate a wide range of commercial agreements (e.g., vendors, patient support programs, speaker programs, distribution, market access)
• Lead legal review of promotional and medical materials through MLR/PRC processes
• Advise on interactions with HCPs, patients, payors, specialty pharmacies, and government entities
• Support commercial and medical affairs activities, including speaker programs, advisory boards, sponsorships, grants, medical information requests, and scientific exchange
• Provide guidance on compliantly navigating regulatory landscape in business activities such as disease education, HCP engagement, advisory boards, and patient-facing materials
• Lead design and implementation of a scalable healthcare compliance program aligned with applicable laws, regulations, and industry guidance to enable commercialization success
• Develop policies, procedures, training, and monitoring frameworks
• Implement transparency and aggregate spend reporting processes
• Proactively identify legal and compliance risks and develop practical mitigation strategies
• Monitor evolving healthcare laws, regulations, and industry trends
• Provide clear, business-oriented guidance to senior leadership
• Support corporate legal matters and business development initiatives as needed
• Manage external counsel effectively
• Contribute to building a high-impact, collaborative legal team

Executive Director, Clinical Development

Marketing Coordinator

Senior Counsel, Commercial and Compliance