Senior Director, Analytical Sciences

About Leona: 

LeonaBio, Inc., headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for high unmet medical needs, including amyotrophic lateral sclerosis (ALS) and treatment-resistant metastatic breast cancer, with the goal of improving patients’ lives. Our lead drug candidates, lasofoxifene and ATH-1105, are novel, small molecule therapies with the potential to address devastating diseases where current treatment options are limited or ineffective. With a strong commitment to scientific excellence and patient-centered innovation, we are dedicated to developing meaningful new therapies for those who need them most. 

About this role: 

LeonaBio is seeking an experienced Senior Director, Analytical Sciences to provide technical and strategic leadership across analytical development activities for drug substance and drug product programs. This role is responsible for vendor management, regulatory authorship, and overall accountability for analytical method development, method validation, specifications, method transfer, and analytical support for lifecycle and change activities. The successful candidate will serve as a cross-functional analytical sciences leader, partnering closely with quality, regulatory, non-clinical, clinical, operations, and product development teams to ensure robust data generation, sound scientific decision-making, and successful advancement of programs through development and regulatory milestones. This is a high-impact opportunity for an experienced analytical sciences professional to shape strategy, drive execution through internal and external resources, and support global regulatory success. 

Responsibilities: 

• Provide technical and strategic oversight for analytical sciences activities across drug substance and drug product programs, including analytical testing, method development, specifications, method transfer, and method validation. 

• Lead analytical development strategy and execution in alignment with program objectives, development timelines, and broader business goals. 

• Direct external analytical resources, including CROs, CDMOs, and contract laboratories, and oversee technical deliverables, timelines, budgets, and overall vendor performance. 

• Review, interpret, and prepare analytical data and documentation to support regulatory submissions, milestone briefing packages, and health authority interactions for US and global programs. 

• Oversee the preparation and compilation of analytical and broader CMC sections required for FDA and Rest of World submissions, ensuring technical quality, completeness, and consistency. 

• Partner with Quality and cross-functional teams to ensure laboratory investigations and quality events, including LIRs, OOS results, nonconformances, and deviations, are appropriately raised, assessed, and driven to timely resolution. 

• Provide analytical leadership for change activities, lifecycle management, and technical risk assessment to support development, scale-up, validation, and commercial readiness. 

• Act as the Analytical Sciences subject matter expert across the business to influence decisions in clinical, non-clinical, regulatory, operations, and product development functions. 

• Identify, author, and maintain key procedures and standards needed to ensure compliant data generation, data handling, data review, and data integrity practices. 

• Develop and manage project timelines, resource plans, and budgets for analytical activities to ensure execution remains aligned with portfolio priorities and company objectives. 
  

Requirements: 

• PhD in Analytical Chemistry or a related scientific field is required. 

• 20+ years of progressive responsibility in Analytical Sciences within the pharmaceutical industry, with deep expertise supporting small molecule drug development. 

• Expert knowledge of analytical development for drug substance and drug product, including method development, method validation, specifications, method transfer, and testing strategy. 

• Strong knowledge of relevant global regulations, regulatory processes, and CMC requirements, with recent experience supporting NDA submissions and approvals. 

• Demonstrated experience reviewing and authoring analytical content for regulatory submissions and briefing packages for US and global health authorities. 

• Proven success managing teams and leading analytical work across organizations with diverse backgrounds, including oversight of external CROs, CDMOs, and contract laboratories. 

• Experience working cross-functionally with Quality, Regulatory, Technical Operations, Product Development, and other stakeholders to resolve complex technical and compliance issues. 

• Strong understanding of cGMP requirements, data integrity expectations, laboratory investigations, deviation management, and analytical support for change control and lifecycle activities. 

• Excellent written and verbal communication skills, with the ability to clearly present data, risks, and recommendations to senior leadership and cross-functional teams. 

• Must be comfortable in a remote environment and willing to travel periodically as business needs require. 

• Must be authorized to work in the United States. 

• This role is currently remote; however, candidates should be willing to support a future hybrid work model with on-site presence 2–3 days per week in the greater Philadelphia area if business needs evolve. 

LeonaBio is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline and termination.