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. The Clinical Development Leader will lead clinical development across the movement disorders portfolio, including development strategy, study execution, data interpretation, regulatory submissions, health authority interactions, and cross-functional collaboration.
Responsibilities
- Movement disorders development: Deep understanding of the disease area, endpoints, rating instruments, and patient experience, 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
- External leadership: Represent Praxis credibly with investigators, KOLs, health authorities, and partners
Skills
- 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 submissions 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 within a small, flexible organization where scope shifts and the role is defined by what needs doing rather than by a job description
- 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
- This position may be performed remotely, but requires the flexibility and willingness to travel as needed
- 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
Benefits
- This position may be performed remotely
- 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
- A phenomenal crew of colleagues who are smart, engaged and inspiring
Company Overview