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
Ensuring delivery of high-quality clinical development content including:
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
Internal interfaces and collaboration
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
External-scientific
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 andsimilar medico-scientific groups, builds networks with scientific experts
Ensures that the patient and physician voice is at the forefront in TA strategy development
Building a culture of risk taking, innovation and peer review across the clinical function
Providing clinical scientific leadership throughout CSL
Providing support and insight into business development opportunities as required
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