Clinical Development Leader - Epilepsies

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Turning promising science into better treatments for epilepsy takes more than expertise. It takes ownership, sound judgment, and the drive to lead trials and translate emerging data into decisions that move medicines forward for the patients we serve. At Praxis, you’ll take clinical leadership across our epilepsy portfolio, spanning adult programs and pediatric studies. You’ll shape development strategy, lead studies, interpret emerging data, drive cross-functional execution, and carry clinical strategy through regulatory submissions and health authority interactions. This is a role for someone who is hands-on and wants to lead the work, not just review and advise on the work of others.  You bring deep epilepsy development experience while also helping build the capabilities of other clinical leaders across the portfolio.

Primary Responsibilities

• Epilepsy development: Apply deep understanding of adult and pediatric epilepsy, trial design, endpoints, and the regulatory pathway – including pediatric requirements such as PIP and PSP – to development strategy and decision-making.
• Clinical strategy and trials: Translate science, emerging data, patient need, and regulatory requirements into development strategies – and personally lead studies from design through execution.
• Data-driven decisions: Interpret emerging clinical and scientific data, identify what matters, and make timely calls when information is incomplete.
• Regulatory strategy: Own substantive clinical content for regulatory filings, briefing materials, and health authority interactions.
• Cross-functional leadership: Drive teams across clinical operations, biostatistics, regulatory, safety, and other disciplines to resolve issues and move programs forward.
• Team development: Bring your program and submission experience to strengthen other clinical leaders, expanding their judgment, ownership, and ability to lead increasingly complex development work.
• External leadership: Represent Praxis credibly with investigators, KOLs, health authorities, and partners.

Qualifications and Key Success Factors

• 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 the 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.
• You’ll thrive here if you take ownership, challenge assumptions with scientific rigor, move with urgency without sacrificing quality, and stay focused on outcomes that matter for patients.
• Thrives in a dynamic environment where priorities shift, scope evolves, and ownership matters more than rigid role boundaries.

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Annualized Base Salary 280000 - 350000 USD