Lead Clinical Development: Lifecycle Strategy (Remote)

Praxis Precision Medicines, Inc.

Northern (KY)

Hybrid

USD 280,000 - 350,000

Full time

7 days ago
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Benefits offered by this job

Health coverage
Life insurance
Disability benefits
401(k) match
Stock options/ESPP
Bonus
Wellness program
PTO & holidays

Job summary

Regular travel may be required as part of cross-functional leadership and external collaborations. A strong track record of leading clinical development programs and favorable regulatory interactions will be essential. The role offers a comprehensive benefits package and competitive compensation.

Qualifications

  • Advanced scientific degree required (MD/PharmD/PhD or equivalent).
  • Track record of leading clinical trials, programs, submissions, or major development decisions.

Responsibilities

  • Identify and drive lifecycle strategy including new indications and label/formulation opportunities.
  • Lead first-in-human and dose-escalation studies using PK/PD and emerging data.
  • Drive clinical strategy and content for IND-enabling submissions and human studies.
  • Lead across mechanisms, indications, and phases to enable timely development decisions.
  • Interpret emerging clinical data to determine what matters and escalate when information is incomplete.
  • Coordinate with clinical operations, biostatistics, regulatory, safety, translational sciences and external partners.

Skills

Clinical leadership
Regulatory decision making
Cross-functional leadership
Strategic thinking

Education

MD, PharmD, PhD or equivalent

Job description

Regular travel may be required as part of cross-functional leadership and external collaborations. A strong track record of leading clinical development programs and favorable regulatory interactions will be essential. The role offers a comprehensive benefits package and competitive compensation.

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