Overview
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.
Responsibilities
* 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 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
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
Qualifications & Experience Requirements
* 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
* Suckinct and clear communication style
* Extensive experience of leading teams and/or line managing a group(s)
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL
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