Full-Time

Clinical Development Leader

Epilepsies

Posted on 8/21/2026

Praxis Precision Medicines

Praxis Precision Medicines

201-500 employees

Clinical-stage biopharma developing CNS therapies

Compensation Overview

$280k - $350k/yr

+ Quarterly bonus + Long-term stock incentives + ESPP + 401(k) match

Remote in USA

Remote

Remote role with flexibility and willingness to travel as needed.

PharmD, PhD, MD

Category
Biology & Biotech (1)
Required Skills
Biostatistics

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Requirements
  • An advanced scientific degree (MD, PharmD, PhD, or equivalent) is required.
  • A track record of personally leading clinical trials, programs, submissions, or major development decisions.
  • Experience owning regulatory submissions, including 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 decisions on emerging data with incomplete information, including knowing what to escalate and when.
  • Comfort operating in a dynamic environment where priorities shift, scope evolves, and ownership matters more than rigid role boundaries.
  • Ability to take ownership, challenge assumptions with scientific rigor, move with urgency without sacrificing quality, and stay focused on patient outcomes.
Responsibilities
  • Apply deep understanding of adult and pediatric epilepsy, trial design, endpoints, and regulatory pathways, including pediatric requirements such as PIP and PSP, to development strategy and decision-making.
  • Translate science, emerging data, patient needs, and regulatory requirements into development strategies and personally lead studies from design through execution.
  • Interpret emerging clinical and scientific data, identify what matters, and make timely decisions when information is incomplete.
  • Own substantive clinical content for regulatory filings, briefing materials, and health authority interactions.
  • Drive teams across clinical operations, biostatistics, regulatory, safety, and other disciplines to resolve issues and move programs forward.
  • Use program and submission experience to strengthen other clinical leaders and expand their judgment, ownership, and ability to lead increasingly complex development work.
  • Represent Praxis credibly with investigators, key opinion leaders, health authorities, and partners.
Praxis Precision Medicines

Praxis Precision Medicines

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Praxis Precision Medicines develops therapies for central nervous system (CNS) disorders, with a focus on conditions caused by neuronal imbalance and genetic epilepsies. Its products aim to restore balance in CNS networks by applying genetic epilepsy insights, progressing through clinical development toward potential commercialization. What sets Praxis apart is its commitment to patient-guided development, incorporating patient and caregiver needs into therapy design, alongside strategic partnerships with other healthcare entities. The company's goal is to deliver effective CNS treatments to patients and caregivers and advance collaborations that support clinical development and eventual market access.

Company Size

201-500

Company Stage

IPO

Headquarters

Cambridge, Massachusetts

Founded

2015

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Simplify Jobs

Simplify's Take

What believers are saying

  • August 6, 2026 FDA mid-cycle meetings showed no major safety issues and no advisory committees.
  • Praxis ended June 30, 2026 with $1.4 billion cash, funding operations into 2028.
  • Commercial hiring and launch systems are already underway for ulixacaltamide and relutrigine.

What critics are saying

  • Vormatrigine missed POWER1 primary endpoint on June 1, 2026, and paused POWER2 enrollment.
  • Relutrigine gained a December 27, 2026 delay after FDA requested major amendment review.
  • An $8.4 billion valuation on pre-commercial assets leaves huge downside if approvals slip.

What makes Praxis Precision Medicines unique

  • Praxis links genetic neuroscience with FDA-backed precision drugs for rare epilepsies and tremor.
  • Ulixacaltamide is first Phase 3 positive essential tremor program, strengthening category leadership.
  • Relutrigine targets SCN2A and SCN8A DEEs, aiming at first-approved therapy status.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Company Match

Stock Options

Company Equity

Performance Bonus

Unlimited Paid Time Off

Paid Holidays

Flexible Work Hours

Growth & Insights and Company News

Headcount

6 month growth

-2%

1 year growth

-4%

2 year growth

-4%
Yahoo Finance
May 17th, 2026
FDA accepts Praxis Precision Medicines NDAs amid $92.6M Q1 loss and cash runway to 2028

Praxis Precision Medicines reported a first-quarter 2026 net loss of $92.56 million whilst confirming FDA acceptance of New Drug Applications for ulixacaltamide in Essential Tremor and relutrigine in SCN2A/SCN8A epileptic encephalopathies. Target action dates are set for 2026 and 2027 respectively. The regulatory milestones advance two programmes into formal FDA review alongside ongoing trials for vormatrigine and elsunersen. The company maintains a cash runway into 2028 as it concentrates resources on its central nervous system pipeline. The narrative projects $724.1 million revenue and $89.5 million earnings by 2029, requiring 359.5% yearly revenue growth. Analysts' forecasts yield a $449.13 fair value, representing 31% upside to current prices, though the most optimistic projections estimate $2.1 billion revenue by 2029.

Yahoo Finance
May 12th, 2026
Wedbush raises Praxis Precision Medicines price target to $166 despite underperform rating

Wedbush maintained an "Underperform" rating on Praxis Precision Medicines, Inc. (NASDAQ:PRAX) whilst raising its price target from $130 to $166, citing concerns about the ulixacaltamide filing and valuation. The FDA has accepted new drug applications for ulixacaltamide and relutrigine, with PDUFA dates of 29 January 2027 and 27 September 2026. Chief executive Marcio Souza said the company is positioning for two US launches within eight months. The clinical-stage biopharmaceutical company reported a net loss of $92.6 million for the quarter ending 31 March 2026. It holds approximately $1.4 billion in cash and investments, extending its financial runway into 2028. Additional clinical readouts are expected in 2026.

Yahoo Finance
May 3rd, 2026
Praxis ties executive pay to ulixacaltamide progress after 283% share gain and $567M raise

Praxis Precision Medicines has scheduled its 2026 annual meeting for 10 June to vote on director elections, auditor ratification and a Say-on-Pay proposal. The biotech company reported positive Phase 3 data for ulixacaltamide in essential tremor and filed an early new drug application. Praxis is implementing performance-based restricted stock units following a year that included a $567.1 million follow-on offering and a 283% share price gain. Vanguard Capital Management has taken a stake exceeding 5%, signalling institutional interest in management's incentive alignment. The company's narrative projects $724.1 million revenue and $89.5 million earnings by 2029, requiring 359.5% yearly revenue growth. Key near-term catalysts include FDA review of ulixacaltamide, whilst ongoing losses and potential dilution remain investor concerns.

Yahoo Finance
Mar 13th, 2026
Biotech Praxis secures $80.5M investment from Driehaus as stock soars 685% ahead of dual FDA filings

Driehaus Capital Management has invested $80.5 million in Praxis Precision Medicines, purchasing 432,510 shares and bringing its stake to 1.87% of assets under management. The transaction, disclosed on 17 February 2026, increased Driehaus's position value by $248.5 million, reflecting both the purchase and share price appreciation. Praxis shares have surged 685% over the past year to $303.37, giving the company an $8.4 billion market capitalisation. The biotech firm recently submitted two FDA applications: ulixacaltamide for essential tremor and relutrigine for rare developmental epilepsies. CEO Marcio Souza estimates the company's four late-stage programmes could generate over $20 billion in revenue if commercialised. Praxis ended 2025 with $926 million in cash and raised an additional $621 million in January, providing funding through 2028.

Intellectia AI
Feb 16th, 2026
Affinity Asset Advisors Acquires New Stake in Praxis Precision Medicines

- **New Investment Disclosure**: On February 13, 2026, Affinity Asset Advisors disclosed a new position by acquiring 185,000 shares of Praxis Precisio...