Clinical Development Leader, Epilepsies

This is a fully remote position, open to applicants in United States.

📋 Description

• Utilize a comprehensive understanding of adult and pediatric epilepsy, trial design, endpoints, and regulatory pathways, including PIP and PSP, to inform development strategy and decision-making.

• Convert scientific insights, emerging data, patient needs, and regulatory requirements into actionable development strategies.

• Take the lead on studies from inception through to execution.

• Analyze emerging clinical and scientific data and make prompt decisions in situations where information is incomplete.

• Be responsible for the substantive clinical content in regulatory submissions, briefing materials, and interactions with health authorities.

• Coordinate cross-functional teams across clinical operations, biostatistics, regulatory affairs, safety, and other related disciplines.

• Enhance the judgment, ownership, and leadership capabilities of other clinical leaders in complex development initiatives.

• Serve as the representative for Praxis with investigators, Key Opinion Leaders (KOLs), health authorities, and partners.

⛳️ Requirements

• An advanced scientific degree (MD, PharmD, PhD, or equivalent) is mandatory.

• A proven history of leading clinical trials, programs, submissions, or significant development decisions.

• Ownership of regulatory submissions, having managed the clinical content of IND, CTA, NDA, or MAA filings, briefing books, and interactions with health authorities.

• Strong decision-making abilities and the capacity to make informed, timely judgments based on emerging data, even when information is incomplete, along with a keen sense of what to escalate and when.

• Comfort in a dynamic work environment characterized by shifting priorities, evolving scope, and the importance of ownership beyond fixed role definitions.

• Demonstrate ownership, challenge assumptions with scientific rigor, act with urgency without compromising quality, and maintain focus on patient outcomes.

• Physical and mental requirements include regular use of computers/devices/office equipment, effective communication, occasional movement, comfort with screen work, basic hand coordination, and sustained focus.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision plans

• Company-funded life insurance

• Accidental Death & Dismemberment (AD&D) benefits

• Disability benefits

• Optional plans for personalized coverage

• Dollar-for-dollar 401(k) match up to 6% on eligible contributions

• Long-term stock incentives

• Employee Stock Purchase Plan (ESPP)

• Discretionary quarterly bonus

• Highly flexible wellness benefit

• Generous paid time off (PTO)

• Paid holidays

• Company-wide shutdowns