Leads the clinical science function across one or more therapeutic areas, setting strategic direction for clinical development and ensuring high-quality execution across the portfolio. Builds and develops a team of clinical scientists, establishes best practices, and drives consistency in study design, data interpretation, and regulatory readiness. Partners with senior cross-functional leaders to shape development strategies and influence key decisions from early development through registration. Contributes to organizational capability building and represents the function in internal governance and external engagements.
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
Salary Range: $272,000.00 to $336,000.00 .Compensation for the role will depend on a number of factors, including a candidate9s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali9s good faith estimate as of the date of publication and may be modified in the future.
