Executive Director, Clinical Development

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $340k - $370k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Notified

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

📣 Marketing

☁️ SaaS

🤝 B2B

Marketing • SaaS • B2B

Notified is a B2B SaaS company that provides media monitoring and communications software for PR and marketing teams. It helps organizations track media coverage, social mentions, and influencer activity; measure campaign performance and audience reach; and manage communications and stakeholder engagement across earned, owned, and social channels. Notified’s platform is used by enterprises and agencies to centralize insights, reporting, and workflows for public relations and corporate communications.

📋 Description

• Serve as the clinical lead for one or more clinical programs, overseeing clinical trial design, execution, and 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 teams • Drive study start-up, enrollment, interim analyses, database locks, topline results, and CSR delivery • Serve as medical monitor, reviewing 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 risk mitigation strategies and patient safety throughout program execution • Contribute to global regulatory strategy and health authority interactions with FDA, EMA, PMDA, and others • 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 • Support publication planning, congress presentations, and external scientific engagement • Build relationships with KOLs, investigators, and external experts • Mentor internal team members and external consultants/CRO partners • Foster collaboration, accountability, urgency, and quality in a lean biotech environment

🎯 Requirements

• 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

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Time off • 401K • Participation in Mineralys incentive plans contingent on achievement of personal and company performance

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