Vice President, Clinical Development

Role Summary

As Vice President of Clinical Development, you will lead the post-readout clinical strategy for our pivotal Phase 3 Frontotemporal Dementia program, reporting to the Chief Medical Officer. You’ll own regulatory engagement with the US FDA and drive clinical leadership through a critical period toward potential filing and launch. You’ll work cross-functionally with Clinical Operations, Regulatory Affairs, Biometrics, and Commercial colleagues to help deliver transformative therapies to patients with neurodegenerative diseases.

Responsibilities

• Serve as lead clinical expert for the Phase 3 Frontotemporal Dementia program following data readout, driving all clinical strategies and partnering on regulatory activities to enable filing.
• Lead strategic and operational engagement with the US FDA, including participation in key meetings and authorship of major regulatory submissions.
• Own the clinical development plan from late-stage study execution through potential BLA filing and NDA approval.
• Provide clinical insights that guide program decisions, ensuring scientific rigor, patient safety, and regulatory compliance at every step.
• Integrate innovative technologies—including AI—to accelerate timelines and improve decision-making across development stages.

Qualifications

• MD, MD/PhD with at least 10 years of clinical drug development experience.
• Proven track record leading programs in rare diseases and CNS, or in neurodegenerative disease.
• Demonstrated success bringing therapies through late-stage development, US FDA interactions and filing, and drug launch; experience as the point-person leading filings with the FDA.
• Experience working independently and cross-functionally in fast-paced, matrixed environments; strong collaboration and influence across cross-functional teams.
• Active user of large language models (LLMs) with a strong interest in evolving AI applications in clinical development and commercialization-readiness.