Praxisprecisionmedicines

Clinical Development Leader, Lifecycle Management

United States - Remote. Posted 2 months ago

The role

You will provide clinical leadership across lifecycle management activities and early-phase development. This involves shaping opportunities, leading early clinical work, and interpreting emerging data to make development decisions.

What you will do

  • Identify and drive opportunities to expand the impact of late-stage and marketed assets
  • Lead first-in-human and dose-escalation studies
  • Apply PK/PD and emerging clinical data to dose selection and decision rules
  • Drive clinical strategy and content for IND-enabling submissions
  • Work across mechanisms, indications, and phases to make clinical development decisions
  • Interpret emerging clinical and scientific data
  • Drive teams across clinical operations, biostatistics, regulatory, safety, and translational sciences
  • Represent Praxis with investigators, KOLs, health authorities, and partners

Required qualifications

  • An advanced scientific degree (MD, PharmD, PhD, or equivalent)
  • 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
  • Comfort operating in a dynamic environment where priorities shift and scope evolves
  • Regular use of a computer, devices or other office equipment
  • Clear communication
  • Occasional movement
  • Comfort with screen work, basic hand coordination, and focus

Benefits

  • 99% of the premium paid for medical, dental and vision plans
  • Company-paid life insurance
  • AD&D
  • Disability benefits
  • Voluntary plans to personalize coverage
  • Dollar-for-dollar 401(k) match up to 6%
  • Long-term stock incentives
  • ESPP
  • Discretionary quarterly bonus
  • Extremely flexible wellness benefit
  • Generous PTO
  • Paid holidays and company-wide shutdowns

About the company

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company focuses on developing high impact medicines for patients and families affected by complex brain disorders.

Clinical Development Leader, Lifecycle Management at Praxisprecisionmedicines | JobZoey