Vice President, Clinical Development

Department: Clinical Development

Location: US (Waltham, MA – Hybrid) or Remote (US)

Geographic Scope: US & Europe

Reports To: Chief Executive Officer

Role Summary

The Vice President, Clinical Development (VP, CD) will serve as a senior clinical leader responsible for the design, execution, and delivery of clinical development programs across the United States and Europe. Reporting directly to the CEO, this physician leader will drive clinical strategy and execution for assigned programs, ensuring scientific rigor, regulatory alignment, and operational excellence.

This role is a critical bridge between corporate strategy and clinical execution, translating portfolio priorities into high-quality clinical development plans and clinical operations while partnering cross-functionally with Regulatory and Quality, Data Sciences, CMC and Translational Sciences. The VP will contribute to global development strategy while maintaining primary accountability for US/EU clinical programs.

Key Responsibilities

Clinical Strategy & Leadership

• Lead clinical development strategy for assigned programs across US & EU, including indication selection, study design and endpoint strategy.
• Translate corporate and portfolio strategy into executable clinical development plans.
• Provide medical and scientific leadership for protocols, investigator brochures, and clinical study reports.
• Contribute to global clinical strategy in collaboration with APAC clinical leadership and executive team.

Protocol Development

• Provide clinical leadership in defining:
• Primary and secondary endpoints
• Clinically meaningful effect sizes
• Patient population and inclusion/exclusion criteria
• Ensure alignment between Protocol design, Statistical Analysis Plan (SAP) and Regulatory strategy

• Partner with Data Management to ensure:
• Appropriate sample size calculations based on realistic assumptions
• Power levels (typically ≥80–90%) are aligned with regulatory expectations and account for event rates, placebo response, variance and patient dropout
• Feasibility of enrollment required to meet statistical targets

Clinical Execution & Oversight

• Oversee execution of clinical trials from early development through later-stage studies focused within US & EU regions, with the potential to lead global studies.
• Provide leadership for Clinical Operations to ensure studies are delivered on time, within budget, and with high data quality.
• Provide medical oversight of CROs, vendors, and investigators to ensure scientific integrity and patient safety.
• Support data review, interpretation, and clinical decision-making throughout study lifecycle.

Regulatory & Medical Governance

• Collaborate with Regulatory Affairs to align development strategies with FDA and EMA expectations.
• Participate in regulatory interactions (e.g., FDA meetings, EMA scientific advice) and support submission activities (IND/CTA, NDA/BLA/MAA).
• Contribute to safety governance, including data monitoring committees and safety signal evaluation.
• Ensure compliance with GCP, ICH, and applicable regulatory standards.

Cross-Functional Collaboration

• Partner with Preclinical, Translational Medicine, CMC, and Data Sciences to ensure seamless development from IND through late-stage trials.
• Work closely with Data Management to ensure that all clinical programs are designed with robust data strategies, statistically sound powering, and appropriate interim evaluation frameworks to support high-quality decision-making and regulatory success.

Leadership & Team Development

• Lead and mentor Clinical Development physicians and scientists within US & EU.
• Serve as a key clinical leader across cross-functional study teams, influencing without direct authority.
• Foster a culture of accountability, scientific excellence, and collaborative problem-solving.
• Contribute to building scalable clinical development capabilities as the organization grows.

External Engagement

• Build relationships with key opinion leaders (KOLs), investigators, and academic institutions.
• Represent the company in external scientific forums, advisory boards, and investigator meetings.
• Support business development activities, including due diligence and clinical asset evaluation.

Qualifications

• MD or MD/PhD required.
• A minimum of 12 years of clinical development experience leading clinical trails.
• Demonstrated experience advancing programs through Phase 1–3 clinical development.
• Experience with regulatory interactions (FDA, EMA) and global clinical trials.
• Background in neuroscience, neurodegeneration, or related therapeutic preferred.
• Strong understanding of GCP, ICH guidelines, and global regulatory frameworks.
• Proven ability to work in a fast-paced, high-growth biotech environment.

Leadership Profile

• Strong clinical and scientific judgment with ability to balance speed and rigor.
• Highly collaborative, with ability to influence cross-functional teams without direct authority.
• Effective communicator capable of translating complex clinical data into clear insights.
• Hands-on leader willing to operate both strategically and tactically.
• High degree of ownership and accountability in a lean, pre-commercial biotech environment.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.