Director, Analytical Strategy

Director, Analytical Strategy Employer CSL Location Kankakee, IL Start date May 12, 2026 View more categories View less categories Discipline Information Technology , Business/Data Analytics , Marketing Required Education Masters Degree/MBA Position Type Full time Hotbed Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details For our global Technical Operations Organization, we are currently looking for a Director, Analytical Strategy The Director, Analytical Strategy is a senior scientific and strategic leadership role responsible for designing and overseeing analytical strategies that support drug discovery, development, and regulatory approval. This position ensures robust, compliant, and innovative analytical approaches across preclinical, clinical programs and LCM. Key Responsibilities Strategic Leadership Develop and lead the global analytical strategy aligned with program and corporate goals​ Provide scientific and regulatory guidance for analytical plans across all development phases (discovery → post-marketing)​ Drive innovation in analytical technologies, platforms, and workflows​ Represent analytical function in cross-functional governance and decision-making forums Scientific Oversight Oversee development, validation, and implementation of analytical methods (e.g., LC-MS/MS, ligand binding assays, biomarkers, immunogenicity)​ Ensure high-quality data generation for PK, PD, biomarker, and immunogenicity studies​ Review and approve analytical study designs, reports, and regulatory documentation​ Troubleshoot complex scientific and technical challenges Regulatory & Compliance Ensure compliance with global regulatory guidelines (FDA, EMA, ICH, GLP, GCP)​ Lead analytical sections of regulatory submissions (IND, CTA, NDA, BLA, MAA)​ Interface with regulatory agencies and respond to health authority queries​ Maintain inspection readiness and quality standards Cross-Functional Collaboration Partner with Clinical Pharmacology, DMPK, Toxicology, Biomarkers, and Clinical Operations​ Support translational strategy and dose selection decisions​ Manage external CROs, academic collaborators, and technology vendors Leadership & Management Lead and mentor analytical scientists and project leaders​ Manage budgets, timelines, and resource allocation​ Build and scale analytical capabilities and infrastructure Your experience PhD in analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field (or MSc with extensive experience) Typically, 12-15+ years in bioanalysis within biotech, pharma, or CRO environments​ Deep expertisein LC-MS/MS, ligand binding assays, biomarkers, and immunogenicity testing​ Strong knowledge of regulatory requirements and analytical validation standards​ Proven leadership and strategic program experience​ Experience supporting regulatory submissions and health authority interactions Are you interested? We are looking forward to receiving your online application. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about

CSL, CSL

Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ . Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL . You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement . Company CSL is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Areas of Expertise We focus and demonstrate global leadership in three distinct areas—rare and serious diseases; influenza vaccines; and iron deficiency and nephrology. Rare & Serious Diseases CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Vaccines As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries. Iron Deficiency & Nephrology With our iron deficiency and iron deficiency anemia expertise in heart failure, kidney disease, gastroenterology or inflammatory bowel disease, patient blood management and women's health, we help patients affected by these conditions to live better, healthier lives. Company info Phone 610-878-4000 Location 1020 First Avenue King of Prussia Pennsylvania 19406 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert