Note: The job is a remote job and is open to candidates in USA. Praxis Precision Medicines is a clinical-stage biopharmaceutical company developing therapies for central nervous system disorders characterized by neuronal imbalance. The Clinical Development Leader will lead clinical development strategy and studies across the epilepsy portfolio, interpret emerging data, oversee regulatory submissions and health authority interactions, drive cross-functional execution, and mentor other clinical leaders.
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
Skills
- This position may be performed remotely, but requires the flexibility and willingness to travel as needed
- * 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
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 your coverage
- Dollar-for-dollar matching up to 6% on eligible 401(k) contributions
- Long-term stock incentives
- ESPP
- Discretionary quarterly bonus
- Extremely flexible wellness benefit
- Generous PTO
- Paid holidays
- Company-wide shutdowns
Company Overview