Clinical Development Leader, Epilepsies

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $280k - $350k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• Apply deep understanding of adult and pediatric epilepsy, trial design, endpoints, and regulatory pathways, including PIP and PSP, to development strategy and decision-making. • Translate science, emerging data, patient need, and regulatory requirements into development strategies. • Personally lead studies from design through execution. • Interpret emerging clinical and scientific data and make timely decisions when information is incomplete. • Own substantive clinical content for regulatory filings, briefing materials, and health authority interactions. • Drive cross-functional teams across clinical operations, biostatistics, regulatory, safety, and other disciplines. • Strengthen other clinical leaders' judgment, ownership, and ability to lead complex development work. • Represent Praxis with investigators, KOLs, health authorities, and partners.

🎯 Requirements

• An advanced scientific degree (MD, PharmD, PhD, or equivalent) is required. • A track record of clinical trials, programs, submissions, or major development decisions that you personally led. • Regulatory submission ownership, having carried the clinical content of IND, CTA, NDA, or MAA filings, briefing books, and health authority interactions. • Strong judgment and the ability to make thoughtful, timely calls on emerging data with incomplete information and knowledge of what to escalate and when. • Comfort operating in a dynamic environment where priorities shift, scope evolves, and ownership matters more than rigid role boundaries. • Take ownership, challenge assumptions with scientific rigor, move with urgency without sacrificing quality, and stay focused on patient outcomes. • Physical and mental requirements include regular computer/device/office-equipment use, clear communication, occasional movement, screen-work comfort, basic hand coordination, and focus.

🏖️ Benefits

• 99% of the premium paid for medical, dental and vision plans • Company-paid life insurance • AD&D benefits • Disability benefits • Voluntary plans to personalize coverage • Dollar-for-dollar 401(k) match up to 6% on eligible contributions • Long-term stock incentives • ESPP • Discretionary quarterly bonus • Extremely flexible wellness benefit • Generous PTO • Paid holidays • Company-wide shutdowns

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