Director of Clinical Biomarker Strategy

About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Director, Clinical Biomarker Strategy

Job Description Summary:

Working collaboratively with the Translational Sciences and Clinical Pharmacology and Translational Development leads, The
Director/Associate Director, Clinical Biomarkers will establish clinical biomarker strategies in prioritized scientific and medical areas. The
level of hire will be determined by candidate capabilities and experience. This role is accountable for designing biomarker strategies and
plans across several therapeutic areas, as well as executional oversight. In addition (s)he will assure that biomarker needs of clinical
programs are articulated as early as possible so that they are developed and ready when needed, working in close collaboration with
biomarker co-lead in Research.

Job Description:

1. Oversees and ensures focus, quality, feasibility, timeliness and innovation in the specific approaches, partnerships and methods
to be deployed in service of the biomarker plan. Ensures development of the appropriate value chain around biomarkers, such
that the strategy and plan can be realized using both internal resources and a best-in-class external provider set for all needed
results.
2. Ensures delivery and appropriate communication of results to broad internal and external audiences in order to shape timely
decision making and enhancement of CSL's product and corporate reputations.
3. With a focus on the needs of development teams and in-line products, serves as a leading internal expert in the deployment of
clinical biomarkers and articulation of the value and mechanism of pipeline programs and marketed products.
4. Through a close partnership with the Translational Sciences biomarker discovery and bioanalytical groups, creates a global
learning and innovation culture in clinical biomarkers, inclusive of staff in Research, Clinical Development, Clinical
Pharmacology, Regulatory, Biostatistics, Clinical Operations, and as appropriate, commercial groups such as Health Economics
and Outcomes Research, Medical Affairs, etc.
5. Partners with biostatistics, pharmacometrics, and data sciences to guide analysis of the biomarker data including the integration
of datasets to enable informed clinical decisions
6. May include the development of co-diagnostic strategies including validation, implementation and regulatory approval of
companion diagnostics
7. Manages external alliances and partnerships to develop and execute a biomarker strategy
Ventures externally to ensure CSL is current with emerging biomarker methodologies and regulatory standards and to build CSL
network and brand amongst biomarker leaders
8. Actively fosters a global network amongst biomarker innovators to stay cutting edge with respect to emerging techniques and
novel applications

Education Requirements:
PhD required

Capabilities:

• l5+ years' pharmaceutical/large biotech Industry experience (level of hire will depend upon relevant industry experience).
• Minimum of 2 years' experience in translational/biomarker science.
• Requires a thorough understanding of disease and drug target biology, large molecule drug develop development, assay validation and clinical diagnostic testing, and application of biomarkers in drug development decision-making
• Experience defining translational approaches and decision making to internal governance and regulators
• Experience in bioinformatics and machine learning approaches to biomarker evaluation is preferred
• Highly diplomatic, with experience leading projects/programs, either as direct or indirect people manager
• Successful in a matrix environment
• Proven experience managing external partnerships