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Clinical Development Leader, Epilepsies

59 minutes ago
United States
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Praxis Medicines

Praxis Medicines

Praxis Medicines is focused on translating genetic insights into the development of precision therapies aimed at treating central nervous system disorders characterized by neuronal imbalance, with a commitment to making significant advancements in neur...

Pharmaceuticals
51-250
View All Jobs 5

Description

  • Apply adult and pediatric epilepsy expertise to development strategy, trial design, endpoints, and regulatory planning, including PIP and PSP requirements.
  • Translate scientific findings, emerging data, patient needs, and regulatory requirements into clinical development strategies.
  • Personally lead clinical studies from design through execution.
  • Interpret emerging clinical and scientific data and make timely development decisions under uncertainty.
  • Own clinical content for regulatory filings, briefing materials, and health authority interactions.
  • Lead cross-functional teams across clinical operations, biostatistics, regulatory, safety, and related functions.
  • Develop other clinical leaders by sharing program and submission experience.
  • Represent Praxis with investigators, key opinion leaders, health authorities, and external partners.

Requirements

  • Advanced scientific degree required: MD, PharmD, PhD, or equivalent.
  • Demonstrated experience personally leading clinical trials, development programs, regulatory submissions, or major development decisions.
  • Experience owning clinical content for IND, CTA, NDA, or MAA filings, briefing books, and health authority interactions.
  • Deep experience in adult and pediatric epilepsy development, including trial design and regulatory pathways.
  • Strong judgment and ability to make timely decisions using incomplete or emerging data.
  • Ability to identify issues requiring escalation and determine when to escalate them.
  • Comfort working in a dynamic environment with shifting priorities, evolving scope, and broad ownership.
  • Scientific rigor, urgency, quality focus, and commitment to patient-relevant outcomes.
  • Willingness and flexibility to travel as needed.
  • Ability to perform regular computer and screen-based work, communicate clearly, and accommodate occasional movement.

Benefits

  • Annual base salary of $280,000–$350,000 USD.
  • Medical, dental, and vision plans with 99% of premiums paid by the company.
  • Company-paid life insurance, AD&D, disability benefits, and voluntary coverage options.
  • Dollar-for-dollar 401(k) matching up to 6% of eligible contributions.
  • Long-term stock incentives and employee stock purchase plan (ESPP).
  • Discretionary quarterly bonus, flexible wellness benefit, generous PTO, paid holidays, and company-wide shutdowns.
  • Remote work option with travel flexibility.

Interested in this position?

Apply directly on the company website

Apply Now

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