Program Executive, Early Phase

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis is seeking an experienced Program Executive to lead one of our high-priority development programs in earlier-stage clinical development. This leader will own the cross-functional strategy, execution, and governance required to advance a potentially best- or first-in-class therapy through proof-of-concept and key value-inflection milestones, while building a clear path toward later-stage development. 

Working across Research, Development, Regulatory, Technical Operations, Translational Sciences, Medical, and other functions, you will align teams around the most important questions, translate emerging data into decisive action, and drive high-quality execution. This is a hands-on leadership role for someone who thrives in ambiguity, challenges assumptions, and knows when to accelerate, adapt, or stop. 

Primary Responsibilities

• Lead the integrated program strategy and development plan through early clinical development, proof-of-concept, and preparation for later-stage development. 
• Drive cross-functional execution, governance, and decision-making against program objectives, timelines, and key scientific, clinical, and business milestones. 
• Own program strategy, budget, resource planning, and investment recommendations, including acceleration, adaptation, and go/no-go decisions. 
• Partner across Clinical Development, Research, Translational Sciences, Regulatory, Technical Operations, Medical, Biometrics, Finance, and other functions to build an integrated evidence-generation strategy. 
• Evaluate emerging clinical, translational, regulatory, competitive, and operational data to identify risks, opportunities, and alternative development paths. 
• Lead preparation for key health authority interactions and ensure alignment across clinical, regulatory, CMC, and evidence-generation strategies. 
• Represent the program with executive leadership, governance committees, partners, and external stakeholders while fostering accountability, transparency, and high performance. 

Qualifications and Key Success Factors 

• Demonstrated experience leading or co-leading therapeutic programs through early clinical development and meaningful value-inflection points, including first-in-human, dose optimization, proof-of-mechanism, proof-of-concept, or transition to later-stage development.
• Proven cross-functional leadership with accountability for integrated program strategy and execution in Phase 1 and/or Phase 2 development.
• Direct ownership of program strategy, budgets, resource planning, governance, and investment recommendations for complex development programs.
• Experience integrating clinical, translational, biomarker, preclinical, regulatory, and competitive evidence to make sound decisions with incomplete or evolving data.
• Experience leading or preparing significant interactions with FDA and/or other global health authorities.
• Demonstrated ability to lead matrixed teams, resolve competing perspectives, and influence senior stakeholders without relying on formal authority.
• Strong understanding of end-to-end drug development and the ability to connect near-term decisions to long-term product and patient impact. 

Preferred Qualifications 

• Experience developing therapies in CNS
• Experience with rare disease development, biomarker-driven development, patient stratification, or innovative proof-of-concept strategies.
• Alliance or partnership management experience.
• Success operating in lean, fast-paced biotechnology organizations where leaders move fluidly between strategy and execution. 

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.