Global Therapeutic Area Head
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!
The Global Clinical Therapeutic Head is responsible for providing innovative scientific and medical leadership in defining the global development strategy for assigned clinical programs within Clinical Development.
The incumbent will have responsibility for strategic clinical development planning; ensuring collaboration with key internal stakeholders to deliver successful license applications and product life cycle management aligned with Commercial Operations strategies and the
regulatory environment. He/she will oversee the activities of assigned (Senior) Clinical
Program Directors/Scientists within his/her Therapeutic Area.
Provides strategic medical leadership and guidance to the global clinical development
activities supporting new registrations and life cycle management of Seqirus therapeutic
compounds, ensuring alignment with commercial strategies and compliance with regulatory guidance where relevant. This includes ensuring alignment of clinical development strategies with target product profiles for all products.
Ensure that the overall scientific and medical content of all clinical programs is sound, is
supported by high value data driven decision-strategies and is documented through program specific Clinical Development Plans.
Anticipate and address future potential clinical development needs and opportunities, based on the clinical character of the compound, evolution of the regulatory and commercial
Determines the overall risk: benefit assessment through securing cross functional alignment and / or transparent discussion of risks and benefit pertinent to the clinical program and
ensure with relevant department heads/ delegates that clear plans to investigate, manage and track risk through the clinical program are reflected in the clinical development plan.
Ensure clinical development planning and strategies are updated for stage gate evaluations and present, as required, clinical development strategies and overall benefit: risk evaluations, pertaining to the assigned therapeutic area, to senior review committees such as Global
Clinical Safety Committee, Project Review Committee, and Portfolio Planning & Prioritization meetings
Experience; Skills and Qualifications include:-
Strong leadership and communication skills and a demonstrated ability to develop constructive and effective relationships with direct reports, colleagues and senior management
Demonstrated ability to think strategically, create innovative strategies and anticipate future trends and consequences
Able to think globally and contemplate multiple aspects and impacts of issues and plan proactively
Able to facilitate brainstorming in teams and bring the creative thoughts of others to solutions
Can develop direct reports with regards to technical skills and leadership competencies;
Understands how to empowers others, and build and lead effective, well integrated, collaborative teams
Works successfully in a matrix organization with multiple disciplines to build collaborative relationships
Able to drive for results through self-motivation and through leading others
Independently minded and focused; able to take decisions and be professional and supportive in driving change
Cross cultural sensitivity demonstrating understanding and acceptance of different cultural parameters
MD and Board Certified (or non-USA equivalent) in Internal medicine or relevant sub-speciality
Clinical development experience leading one or more therapeutic areas or complex clinical programs with a working knowledge of pharmaceutical and regulatory development
processes is essential.