Executive Director, Head of Clinical Science, Medical Writing & Decision Support

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

The incumbent will be responsible for the quality and delivery of high-quality clinical development documents and oversight of clinical study delivery across the portfolio in collaboration with strategic CRO partners. Responsible for overseeing the recruiting, staffing and development of the clinical scientists and medical writing specialists in the group. Serve as the decision support lead for the SVP Portfolio Development (PD) and ensure excellence throughout the Portfolio Development organization.

Oversight of Individuals

• Recruiting, staffing, training and development of clinical scientists and medical writing specialists in the group, to maintain a dynamic and cutting-edge level of medical scientific expertise and advanced drug development approaches
  

• Clinical development plans, protocols, study reports, common technical document modules and publications in academic journals
  
• Regulatory submissions and meetings
  
• Stage-gate and benefit -risk evaluations and assessments
  
• Presentations at scientific and technical review committees
  
• Implementation of clinical recommendations from all advisory and governance committees
  

• Oversight of and collaboration with partnering functions, e.g. Research, GRA & Safety, POE, TES, CROs and Medical Writing Vendors
  
• Effecting extensive and collaborative dialogue with TA co-leads to optimize project strategy
  
• Working with Head Clinical Operations to ensure appropriate resourcing to support TA activities and to ensure project planning and execution is aligned with TA Priorities
  
• Maintaining effective oversight of quality in conjunction with appropriate Quality functions
  

• Enhancing the reputation of the Company through a culture of scientific integration of the department with academia and other partners through visible publication record, KOL Interactions, presence at scientific conferences, membership of consortia and similar medico-scientific groups, builds networks with scientific experts
  
• Ensures that the patient and physician voice is at the forefront in TA strategy development
  

• Experience across all phases of development, FIH, POC, late-stage development and life cycle management
  
• Strong track record of oversight of successful drug development programs
  
• Experience across a wide range of regulatory interactions e.g. filings, Ad coms etc
  
• 10yrs+ of pharma experience in clinical development
  
• Strong personal leadership skills
  
• High level of self-awareness and the awareness of personal impact
  
• Enhanced organizational awareness and the ability to interact and influence from the team level to senior management
  
• Succinct and clear communication style
  
• Extensive experience of leading teams and/or line managing a group(s)