Clinical Development Leader – Lifecycle Management

Job not on LinkedIn

🔥 5 minutes ago

🇺🇸 United States – Remote

💵 $280k - $350k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Identify and drive lifecycle-management opportunities for late-stage and marketed assets, including new indications, label expansion, and formulation opportunities • Lead first-in-human and dose-escalation studies • Apply PK/PD and emerging clinical data to dose selection, decision rules, and next-stage development • Drive clinical strategy and content for IND-enabling submissions • Make decisions required to move programs into human studies • Work across mechanisms, indications, and development phases • Interpret emerging clinical and scientific data and make timely decisions with incomplete information • Lead cross-functional teams across clinical operations, biostatistics, regulatory, safety, translational sciences, and other disciplines • Represent Praxis with investigators, KOLs, health authorities, and partners

🎯 Requirements

• An advanced scientific degree (MD, PharmD, PhD, or equivalent) is required • Track record of personally leading clinical trials, programs, submissions, or major development decisions • Ownership of regulatory submissions, including clinical content of IND, CTA, NDA, or MAA filings, briefing books, and health authority interactions • Strong judgment and ability to make timely decisions on emerging data with incomplete information • Ability to identify what to escalate and when • Comfort operating in a dynamic environment where priorities and scope shift • Ability to take ownership, challenge assumptions with scientific rigor, move with urgency without sacrificing quality, and focus on patient outcomes • Regular computer and 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) matching 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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