Program Executive – Early Phase

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the comprehensive program strategy and development plan throughout early clinical development, proof-of-concept, and preparations for advanced-stage development.

• Facilitate cross-functional execution, governance, and decision-making aligned with program objectives, timelines, and crucial scientific, clinical, and business milestones.

• Assume responsibility for program strategy, budget, resource planning, and investment recommendations, including acceleration, adaptation, and go/no-go decisions.

• Collaborate with Clinical Development, Research, Translational Sciences, Regulatory, Technical Operations, Medical, Biometrics, Finance, and other departments to establish a cohesive evidence-generation strategy.

• Assess emerging clinical, translational, regulatory, competitive, and operational data to pinpoint risks, opportunities, and alternative development pathways.

• Lead the preparation for significant health authority interactions and ensure alignment among clinical, regulatory, CMC, and evidence-generation strategies.

• Represent the program to executive leadership, governance committees, partners, and external stakeholders, while promoting accountability, transparency, and high performance.

• Convert emerging data into decisive actions and ensure high-quality execution across a priority development program.

⛳️ Requirements

• Proven experience in leading or co-leading therapeutic programs through early clinical development and critical value-inflection points, such as first-in-human trials, dose optimization, proof-of-mechanism, proof-of-concept, or transition to later-stage development.

• Established cross-functional leadership with responsibility 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 initiatives.

• Experience in integrating clinical, translational, biomarker, preclinical, regulatory, and competitive evidence to make informed decisions with incomplete or evolving data.

• Experience in leading or preparing for significant interactions with the FDA and/or other global health authorities.

• Proven ability to lead matrixed teams, resolve differing perspectives, and influence senior stakeholders without relying on formal authority.

• Strong grasp of end-to-end drug development and the ability to connect short-term decisions with long-term product and patient outcomes.

• Preferred: Experience in developing therapies for CNS.

• Preferred: Experience in rare disease development, biomarker-driven approaches, patient stratification, or innovative proof-of-concept methodologies.

• Preferred: Experience in alliance or partnership management.

• Preferred: Success in operating within lean, fast-paced biotechnology firms where leaders seamlessly transition between strategy and execution.

• Comfort with screen work, basic hand coordination, focus, regular use of computer/device/office equipment, effective communication, and occasional movement.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision plans.

• Company-sponsored life insurance, AD&D, disability benefits, and optional plans.

• Dollar-for-dollar matching up to 6% on eligible 401(k) contributions.

• Long-term stock incentives and Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonuses.

• Highly flexible wellness benefits.

• Generous paid time off (PTO).

• Paid holidays.

• Company-wide shutdowns.

• Reasonable accommodations may be provided to enable individuals with disabilities.