Executive Director, Clinical Pharmacology and Translational Development-Transplant TA

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

The Executive Director, Clinical Pharmacology & Translational Development (CPAT) -Transplant is a highly strategic and influential senior medical leadership role within R&D. The position within the CPAT function, is focused on both providing and leading crucial clinical and translational input to early stage R&D projects within the Transplant portfolio (typically from mid-stage Research up to clinical proof-of-concept). Key features of this role are: -be scientifically and medically qualified, with at least 8 years relevant scientific and/or clinical development experience in pharma or academia; -be involved, by direct clinical leadership of a program or through management of direct reports (including the roles of Directors and Senior Directors), in a wide range of early R&D pipeline projects and/or research -ability to independently lead an early research / development program by utilising proven, advanced experience involving innovative strategy, matrix team and operational leadership -have a thorough understanding and proven experience to independently undertake Regulatory Agency interactions; -work in close collaboration with Research, Clinical Development (CD) functions, Regulatory Affairs, Non-Clinical Development, Product Development, Commercial/ Business Development and Project Management; -ability to lead or oversee medical monitoring work; -ability to independently present and defend clinical strategies to senior colleagues and governance committees; -have a thorough understanding of, and advanced experience in, the application of translational medicine methods to programs within the Transplant TA -ability to form strategic relationships with world-leading KOLs to advance programs. -ability to apply Commercially-based thinking to clinical program and disease area strategy; -provide leadership for first-in-human (FIH) study conduct -have a proven ability to provide medical / scientific knowledge

Executive Director, Clinical Pharmacology and Translational Development-Transplant TA

The Executive Director, Clinical Pharmacology & Translational Development (CPAT) -Transplant is a highly strategic and influential senior medical leadership role within R&D. The position within the CPAT function, is focused on both providing and leading crucial clinical and translational input to early stage R&D projects within the Transplant portfolio (typically from mid-stage Research up to clinical proof-of-concept).

Key features of this role are:
-be scientifically and medically qualified, with at least 8 years relevant scientific and/or clinical
development experience in pharma or academia;
-be involved, by direct clinical leadership of a program or through management of direct reports (including the roles of Directors and Senior Directors), in a wide range of early R&D pipeline projects and/or research
-ability to independently lead an early research / development program by utilising proven, advanced experience involving innovative strategy, matrix team and operational leadership
-have a thorough understanding and proven experience to independently undertake Regulatory
Agency interactions;
-work in close collaboration with Research, Clinical Development (CD) functions, Regulatory
Affairs, Non-Clinical Development, Product Development, Commercial/ Business Development
and Project Management;
-ability to lead or oversee medical monitoring work;
-ability to independently present and defend clinical strategies to senior colleagues and governance committees;
-have a thorough understanding of, and advanced experience in, the application of translational medicine methods to programs within the Transplant TA
-ability to form strategic relationships with world-leading KOLs to advance programs.
-ability to apply Commercially-based thinking to clinical program and disease area strategy;
-provide leadership for first-in-human (FIH) study conduct
-have a proven ability to provide medical / scientific knowledge

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  Main Responsibilities and Accountabilities
  
  • Mentor and manage medical direct reports within Clinical Pharmacology & TranslationalDevelopment function.
  • Provide medical and disease area knowledge in support of strategy and projects in the early R&D pipeline (primarily from Stage Gates 2 to 4 in CSL's Portfolio governance), working closely with Therapeutic Area leads / TALTs.
  • Work closely with the Functional leadership to build medical and clinical leadership capabilities within the function around these priorities
  • Provide medical and scientific leadership (incorporating early clinical program leadership & translational strategy) for pipeline programs from SG1 to POC (eg Entry into Research through Proof of Concept).
  • Oversee and develop innovative early clinical development (including translational science and experimental medicine) strategies to evaluate functional relevance of targets in human disease.
  • Devise, lead and implement innovative and industry-leading early clinical development plans, ensuring cross-functional engagement and alignment of strategies with Commercial needs.
  • Form and lead a Clinical Development Team (CDT) for post-Stage Gate 2 projects.
  • Work closely alongside the Research's Translational Science group to ensure that clinical assay and Translational Science/biomarker plans receive appropriate clinical input and peer review and are endorsed and integrated into the early Clinical Development Plan.
  • Support qualification of PD/disease markers for early assessment of clinical outcomes.
  • Work closely with experts within CP&P to have pharmacokinetic and pharmacometric aspects of assigned projects fully covered and integrated into clinical plans.
  • Conduct of early clinical (including FIH) studies: ensure close cross-functional engagement (e.g., with Biostats, Clinical Safety, Non-Clinical Safety/Tox, Clinical Operations, Regulatory, Medical Writing) in the planning and enabling of these studies. Ensure clear and timely cross functional communications in this endeavor.
  • Lead clinical input into early Target Product Profiles for development.
  • Lead the design and protocol development for an early (Phase Ia/Ib and/or Phase IIa) clinical study.
  • Lead clinical contributions to regulatory documents, including Investigator Brochures and dossiers for Agency interactions. Leads the resolution of clinical queries from regulatory agencies for assigned studies.

Education

• Scientifically/medically qualified (PhD and/or MBBS /MD) from an internationally recognised Medical School/College.
• Fellowship or registration with a Specialist Board advantageous.

Essential experience

• A minimum of 12 years post-graduation, with at least 2 years post graduate research experience;
• .At least 8 years relevant intensive scientific and/or clinical development
• experience in pharma or academia, with attention to Transplant medicine/Transplant immunology.
• Proven ability to meet the requirements set out in Responsibilities above.
• Rigorous scientific/research knowledge within Transplant Immunology

Advantageous experience

• Functional managerial or leadership experience.
• Laboratory research methods.

Education

• Scientifically/medically qualified (PhD and/or MBBS /MD) from an internationally recognised Medical School/College.
• Fellowship or registration with a Specialist Board advantageous.

Essential experience

• A minimum of 12 years post-graduation, with at least 2 years post graduate research experience;
• .At least 8 years relevant intensive scientific and/or clinical development
• experience in pharma or academia, with attention to Transplant medicine/Transplant immunology.
• Proven ability to meet the requirements set out in Responsibilities above.
• Rigorous scientific/research knowledge within Transplant Immunology

Advantageous experience

• Functional managerial or leadership experience.
• Laboratory research methods.