The Opportunity

Reporting to a Global Clinical Lead, you will play a multifunctional, clinical individual contributor role in the Immunology and Transplant Therapeutic Area (TA). You will be responsible for translation of the TA and global product strategy into clinical development strategy and for delivery of clinical studies accordingly. You will author regulatory dossiers, including briefing documents, submission summary documents (SCE, SCS, CO) and responses to questions.

As a matrix leader, you will provide strategic and tactical clinical and medical leadership to assigned clinical development program(s) or individual clinical trial(s) from conceptualization through execution. As medical subject matter expert in the assigned therapeutic area, you will function as the clinical representative on Clinical Development Team(s) (CDT) and on Project Strategic Teams(s) (PST) as assigned.

• Create clinical development strategies and delivery plans for investigational or marketed products according to the strategy of Therapeutic Area and global Product Strategy Team.
  
• Author program and study level documents and educational materials for internal and external trainings according to the scientific/medical strategy; contribute to the CSR and external presentations and manuscripts, supporting appropriate scientific and medical interpretation and communication of clinical trial data; author study reports and as SME, contribute to regulatory dossiers , including briefing documents, submission summary documents (SCE, SCS, CO) and responses to questions
  
• Identify potential challenges, risks and roadblocks associated with the global clinical development strategy or its execution and act as a leader and subject matter expert in developing solutions to address these, working cross-functionally with important partners and matrix team members
  
• Be a senior medical representative on the cross-functional therapeutic area clinical development and product strategy teams as assigned; present study data and program strategic plans to internal governance committees for endorsement and main program milestones; support product label development and maintenance, provide product/program specific input for target product profile(s)
  
• Deliver clinical programs by providing scientific and clinical development expertise for the safe, efficient, and timely execution of assigned programs, ensuring the highest quality and full compliance of all outputs
  
• Accountable for global medical oversight of selected product(s) within the assigned therapeutic area(s) and responsible for defining and implementing medical monitoring and oversight strategy for individual clinical studies to ensure exceptional patient safety and data integrity, including ongoing review of blinded data
  
• Interface with key internal and external stakeholders; represent CSL as the scientific subject matter expert at external meetings including those with Regulators, Investigators, Steering Committees, Advisory Groups
  
• Oversee the activities of Clinical Scientists or other Clinical Directors in the execution of clinical studies if assigned and contribute to diverse working groups to support continuous process improvement
  
• Assist the TA Global Clinical Lead in ensuring that appropriate personnel is informed of the progress of studies of our company's and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility
  
• Support BD&L activities, (potentially across therapeutic areas based on scientific background and drug development expertise) by providing medical/scientific evaluation of potential new products and competitor assessments and makes recommendations according to the strategic fit in the respective TA
  
• Maintain awareness of scientific developments within their area of expertise, including new scientific findings and research methodologies
  

• MD (Medical Doctor degree) or international equivalent from a recognized school of medicine plus accredited residency
  
• PhD or board certification in therapeutic areas of interest for CSL including Immunology and Transplant or specialty training in Pharmaceutical Medicine are desirable
  
• Two (2) years minimum experience as a physician in patient care.
  
• 5 + years pharmaceutical / biotechnology industry experience, which includes accountability for medical oversight/evaluation or Phase 2b/3 clinical development experience. Relevant academic research experience will also be considered.
  
• Extensive knowledge of the drug development process and clinical research methodologies including experience in clinical trial design, data analysis/statistics and data interpretation; knowledge of global and regional regulations, ICH/GCP, adverse event management.
  
• Demonstrated experience with global regulatory submissions (e.g., NDA, BLA, MAA) preferred.
  
• Experience addressing and managing complex medical issues in the pre-approval and post-approval environment.
  
• Track record of medical credibility and excellence - achievement in pharmaceutical development, ability to coordinate and execute clinical development.
  
• Demonstrated record of scientific scholarship and achievement, including successful authorship of peer-reviewed scientific publications.