This role leads clinical regulatory strategy across Denali's rare disease development portfolio, from IND/CTA through marketing application and lifecycle management, ensuring program-level regulatory strategies are scientifically rigorous, globally coherent, and aligned with the function-wide strategy set by the Head of Global Regulatory & Clinical QA. It serves as the senior regulatory strategist and primary Health Authority interface for these programs, leads a team of Global Regulatory Leads, and represents Clinical Regulatory - Rare Diseases to executive leadership and, as needed, the Board, shaping how the organization engages with global Health Authorities and positions itself within an evolving regulatory landscape. The role anticipates regulatory challenges across the rare disease and CNS biologics portfolio and translates them into program and portfolio strategy, rather than program-level or submission-level tactics. The role requires a strong understanding of how FDA and other Health Authorities are evolving, and a willingness to use AI and other emerging tools to strengthen regulatory research, intelligence, and strategy. Key Accountabilities / Core Job Responsibilities: - Leads development and execution of global regulatory strategy for the rare disease portfolio, from IND/CTA through BLA/MAA and lifecycle management, ensuring cross-program consistency and alignment with corporate objectives and function-wide regulatory strategy - Serves as the first escalation point for regulatory risk on rare disease programs, framing benefit-risk and regulatory options for the Head of Regulatory and program governance committees, and resolving conflicts between program-level strategies and organizational portfolio priorities - Represents Clinical Regulatory Affairs - Rare Diseases to executive leadership, program governance committees, and, as needed, the Board and external stakeholders on matters of regulatory strategy, risk, and probability of regulatory success - Leads strategy, preparation, and direct engagement for major Health Authority interactions (e.g., FDA Type B/C and End-of-Phase meetings, pre-BLA meetings, and Advisory Committees; EMA scientific advice and CHMP procedures; PMDA consultations), including negotiations on endpoints, trial design, and approval pathways - Drives strategy for expedited and rare disease pathways (Breakthrough Therapy, RMAT, Fast Track, Accelerated Approval, Orphan Drug, Rare Pediatric Disease, PRIME), including surrogate and intermediate clinical endpoint strategy, natural history and external control approaches, small-population trial design, and confirmatory evidence planning - Owns the clinical regulatory strategy and content of INDs, CTAs, BLAs, and MAAs, including briefing documents, clinical modules, and Health Authority responses, ensuring quality, consistency, and defensibility of regulatory positions - Provides regulatory input to target product profiles, clinical development plans, protocol design, and integrated evidence strategy, including patient-reported outcome, biomarker, and pediatric (PSP/PIP) strategy - Monitors and interprets FDA trends, policies, and ways of working, and shifts in the broader global regulatory landscape relevant to rare disease and CNS biologics development, and translates them into program strategy and functional policy positions - Builds, leads, and develops a team of Global Regulatory Leads (Senior Directors and Directors), setting the function's talent, capability, and succession plans for Clinical Regulatory - Rare Diseases in partnership with the leader of Regulatory - Drives cross-functional alignment with Clinical Development, Clinical Operations, Biostatistics, Safety, Regulatory CMC, Regulatory Operations, Quality, and Commercial leadership on regulatory implications of program and portfolio decisions - Establishes and applies functional governance frameworks, standards, and best practices for regulatory strategy development, risk assessment, and Health Authority engagement - Represents Denali in external regulatory and policy forums (e.g., industry associations, FDA and EMA public meetings) and contributes to regulatory intelligence and functional policy positions - Promotes the use of AI tools for regulatory research, intelligence gathering, and strategy development, and supports continuous improvement of how the team prepares for and engages with Health Authorities - Supports business development due diligence and partnering activities with regulatory assessments and strategy input as needed Qualifications/Skills: - Bachelor's degree in a life science or related field required; advanced degree in life sciences (PhD, PharmD, MD, or MS) strongly preferred - Typically 15+ years of relevant biopharmaceutical regulatory affairs experience (or equivalent years with an advanced degree), including 7+ years in a senior management capacity leading regulatory teams and Global Regulatory Leads - Demonstrated success leading global regulatory strategy across a multi-program portfolio, including direct leadership of FDA and EMA interactions and at least one marketing application (BLA/MAA) through approval - Deep knowledge of US, EU, and Japan regulations and guidance for biologics, including expedited pathways and accelerated approval; substantial direct experience in rare disease development required, with CNS experience strongly preferred - Proven ability to lead through ambiguity and translate scientific, clinical, and cross-therapeutic-area insight into practical, defensible regulatory strategy - Strong executive presence and communication skills, with demonstrated success presenting regulatory strategy and risk to boards, executive committees, and Health Authorities - Deep familiarity with FDA, including current review division trends, policy direction, and ways of working, and the ability to anticipate how these will shape rare disease development and approval - Familiarity with the use of AI tools for research, regulatory intelligence, and strategy development, and openness to adopting new technologies and ways of working - Ability to travel for Health Authority meetings and external engagements Salary Range: $269,000.00 to $350,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s 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 Denali’s good faith estimate as of the date of publication and may be modified in the future.