About this role
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.
Your role
The incumbent will be responsible for the quality and delivery of clinical studies and clinical and regualtory documents 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.
Your responsibilities will include
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
- Member of the Clinical Development Leadership Team
- Will be responsible for managing a team of approximately 50 Scientists .
- Oversight of and collaboration with partnering functions, e.g. Clinical Operations, Research, GRA & Safety to assure an effective project related deliveries
- Participate and/or lead enterprise initiatives
- 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 the scientific community 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 health-care provider voice is integrated into CSL’s development mindset
Building a culture of risk taking, innovation and peer review across the clinical function
Providing clinical scientific and medical writing leadership throughout CSL
Providing support and insight into business development opportunities as required
Your skills & experience
- Graduate level degree (M.Sc, PhD, MD etc) preferred.
- 10 years+ of Pharma experience in clinical development
- Clinical Scientist experience across all phases of development, FIH, POC, late-stage development and life cycle management.
- Medical writing experience.
- Strong track record of leadership skills.
- Enhanced organizational awareness and the ability to interact and influence from the team level to senior management
- Extensive experience of leading teams and/or line managing a group(s)
#LI-Hybrid
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.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, 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.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Other facts
About CSL
CSL Plasma is one of the world’s largest collectors of human plasma. We are committed to excellence and innovation in everything we do. Our work ensures that tens of thousands of people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because people’s lives depend on us. See our community guidelines: https://bit.ly/2IApjpz.
Supported by parent company CSL Behring, the global leader in plasma protein biotherapeutics, CSL Plasma has more than 280 plasma collection centers globally. CSL Plasma also has a state-of-the-art testing laboratory that features some of the most advanced technology, instrumentation and automation in the field; two logistics centers, one in Dallas and one in Indianapolis. Our corporate headquarters in Boca Raton, Florida.
Our U.S. plasma collection centers are committed to the highest standards of quality and safety. When you donate, you give a valuable gift to those who require plasma-derived therapies to live healthier lives.
The CSL Group has a combined heritage of outstanding contribution to medicine and human health with more than 100 years experience in the development and manufacture of vaccines and plasma protein biotherapies.
With major facilities in Australia, Germany, Switzerland and the US, CSL has over 30,000 employees working in more than 35 countries. See our community guidelines: https://bit.ly/3QZbZeZ
What you'll do
- The Executive Director will oversee the quality and delivery of clinical studies and documents, managing a team of approximately 50 scientists. Responsibilities include recruiting, training, and ensuring high-quality clinical development content in collaboration with various partners.
Ready to join CSL?
Take the next step in your career journey