Key Accountabilities / Core Job Responsibilities:

• Lead clinical team in new therapeutic areas or highly complex projects including the development of multiple, complex clinical protocols, informed consents, and other study materials

• Lead, develop, and manage a team of clinical scientists, including hiring, coaching, performance management, and career development

• Set clinical science strategy across programs or therapeutic areas, ensuring alignment with overall development and regulatory objectives

• Oversee the design and execution of clinical studies, providing direction on protocols, endpoints, biomarkers, and data strategies

• Ensure scientific rigor and consistency in data monitoring, data review, interpretation, and decision-making across studies and programs

• Guide preparation and review of key regulatory documents, including INDs, CTAs, NDAs, briefing documents and BLAs, ensuring quality and strategic alignment

• Partner with senior leaders in clinical development, development operations, regulatory, translational sciences, and biometrics to drive integrated program strategies

• Establish and scale best practices, tools, and standards for clinical science to improve quality, efficiency, and inspection readiness

• Contribute to portfolio governance, providing clinical science input into prioritization, risk assessment, and milestone decisions

• Support business development activities, including due diligence and evaluation of external opportunities

• Represent the organization in regulatory interactions, scientific forums, and external collaborations as a clinical science leader

Qualifications / Skills:

• Ph.D. in a scientific or medical discipline; typically 15+ years of experience in clinical science or clinical development within biotech or pharmaceutical environments, including prior people leadership experience

• Demonstrated experience leading teams and influencing cross-functional strategy across multiple clinical programs or a therapeutic area

• Deep expertise in clinical study design, data interpretation, and regulatory submissions across early- and late-phase development

• Proven ability to operate at a strategic level, driving decisions in complex, matrixed environments

• Strong leadership and communication skills, with the ability to influence senior stakeholders internally and externally

• Experience in biomarkers, rare disease, or complex indications (e.g., neurology, pediatrics) strongly preferred

• Track record of building processes, mentoring talent, and scaling organizational capability