About the role

Aplyr's Quick Take

This role is about leading the analytical strategy for drug development, ensuring compliance and innovation in analytical methods. You'll oversee a team, manage budgets, and work closely with various departments and regulatory bodies. It's a senior-level position requiring deep expertise in analytical chemistry and significant leadership experience.

Good fit

Ideal candidates have a PhD and 12-15+ years in bioanalysis, particularly in biotech or pharma. Strong leadership skills and a collaborative working style are essential for success in this role.

Worth noting

The position involves direct interaction with regulatory agencies and requires maintaining inspection readiness, which may be a high-pressure aspect of the job. The role also emphasizes innovation in analytical technologies, which could appeal to those passionate about advancing scientific methods.

The Analytical Strategy Director is a key scientific and strategic leadership role. In this position you will be responsible for developing and driving analytical strategies that support drug discovery, development, and regulatory approval. The position ensures the implementation of robust, compliant, and innovative analytical approaches across preclinical and clinical development programs, as well as throughout product life cycle management (LCM).

Main Responsibilities & Accountabilities

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

Qualifications & Experience Requirements

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 expertise in 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.

Aplyr's read

CSL is a leader in biotechnology, focusing on therapies for rare diseases, with a diverse team dedicated to innovation and global impact.
Synthesized from recent postings & public sources

What's promising

•CSL has a strong focus on rare and serious diseases, offering a unique niche in the biotech industry.
•Recent hiring for senior roles indicates growth and investment in leadership and strategic capabilities.
•Global presence provides employees with opportunities for international collaboration and career development.

What to watch

•Highly specialized focus may limit opportunities for those outside the biotechnology field.
•Complex regulatory environment can pose challenges for compliance and operational efficiency.
•Rapid expansion may lead to integration challenges across diverse global teams.

Why CSL

•CSL's commitment to rare disease therapies differentiates it from broader-focused biotech firms.
•The company offers a wide array of roles, from regulatory affairs to ethics and compliance.
•CSL's global operations provide a platform for employees to engage in diverse cultural and professional experiences.

Aplyr’s read is generated by AI from public sources. Was it useful?