Senior Director and Global Lead, Clinical Biomarkers
CSL Behring
, King of Prussia, PA, US
5d ago

With operations in 35+ nations and 20,000 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 the second largest influenza vaccine company 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! Responsibilities Senior leader accountable for designing both the portfolio biomarker strategy and plan, as well as contributing to its execution.

This leader will ensure that the 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. Qualifications Collaboratively with the Leader of Translational Research, The Global Lead, Clinical Biomarkers will establish a broad strategy and delivers an overarching plan to establish CSL as a global leader in clinical biomarkers in prioritized scientific and medical areas.

Surveys the portfolio and future interests of the TAs, and identifies the best opportunities to drive value through clinical biomarkers, given the state of CSL’ knowledge and available techniques.

Articulates the strategy, plan and associated capacity and capability gaps to senior leaders so there is a short, medium and long term road map for CSL to significantly evolve clinical biomarker capabilities Oversees and ensures the creation of specific value-

add objectives of the clinical biomarker plan in accordance with TALT and project team priorities. These priorities may be both mechanistic and disease oriented.

Oversees and ensures focus, quality, timeliness and innovation in the specific approaches, partnerships and methods to be deployed in service of the biomarker plan.

These may include (but are not limited to) internally / externally partnered activities such as : Identification of pharmacodynamics markers specific to the MOA, and their relationship to dose and efficacy in relevant model systems In vitro studies to explore target engagement approaches and dynamics Disease understanding and / or biomarker characterization in patient matrix MOA exploration or benchmarking of internal asset or competitor PD response in patient populations Use of novel imaging, -

omics and / or other innovative assessment methods to examine the effect of drug on relevant tissues 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. 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 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 to articulation of the value and mechanism of pipeline programs and marketed products.

Through a close partnership with the Research Biomarker Discovery group, creates a global learning and innovation culture in clinical biomarkers, inclusive of staff in Research, CPAT, CRD, GRA, Biostatistics, Clinical Operations, and as appropriate, commercial groups such as Health Economics and Outcomes Research, Medical Affairs, etc.

Deploys innovative methods and practice to the generation of value-enhancing clinical biomarker opportunities Supports the defense of biomarker approaches in regulatory packages by drawing on internal and external science Recruits, develops and manages a team of clinical biomarker experts to deliver the plan Leverages personal and extended networks to recruit high performing and high potential clinical translational scientists, who would support the clinical translational working groups inclusive of Research, CRD and other appropriate personal needed to define project-

level clinical translational plans Develops this talent to be the stewards of a sustainable clinical translational innovation ecosystem at CSL Serves as a global ambassador for CSL externally in the area of applied clinical biomarker methods and innovation Proactively and strategically communicates to relevant audiences re CSL’s use of clinical biomarkers to inform development program decisions Ventures externally to ensure CSL is current with emerging biomarker methodologies and regulatory standards Actively fosters a global network amongst biomarker innovators to stay cutting edge with respect to emerging techniques and novel applications Attends and presents at global scientific meetings to build CSL network and brand amongst biomarker leaders Education : PhD required Capabilities 8+ years in translational medicine / science Experienced people manager Successful in a matrix environment Deep experience with external partnerships and how to run these Experience defining translational approaches and decision making to internal governance and regulators Experience in overseeing a portfolio of activities and developing a new or early organization Domestic and International Travel will be required-

approx 20-25% Worker Type : Employee Worker Sub Type : Regular

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