Executive Director, Clinical Development

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MDWerks Inc.

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1 - 10 funcionários

📱 Mídia

🤝 B2B

Media • B2B • Marketing

A MDWerks Inc. é uma empresa dinâmica que se especializa na distribuição de comunicados de imprensa, permitindo que as empresas compartilhem suas notícias de forma eficaz com a mídia, investidores e consumidores. A empresa utiliza opções de distribuição direcionadas e ferramentas inovadoras, como um gerador de comunicados de imprensa com IA, para ajudar os clientes a simplificar a criação de conteúdo e aumentar sua visibilidade na mídia. A MDWerks também oferece um banco de dados abrangente de contatos de mídia, alimentado por IA, para facilitar o alcance eficiente e melhorar as taxas de engajamento com jornalistas.

Descrição

• 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.

🎯 Requisitos

• MD or equivalent medical degree required; board certification preferred in Internal Medicine, Cardiology, Nephrology, Endocrinology, or related field • 10+ years of industry clinical development experience, including significant late-stage / registrational trial leadership • Prior experience serving as medical monitor and clinical lead for Phase 2/3 studies • Proven experience with NDA / BLA submission support and health authority interactions • Strong understanding of GCP, ICH guidelines, safety reporting, and global clinical development processes • Demonstrated ability to lead cross-functional teams and influence without direct authority • Strong scientific communication and presentation skills • Experience in hypertension, cardiovascular, renal, or metabolic disease strongly preferred.

🏖️ Benefícios

• These positions are 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