With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The position holder is responsible for both scientific input to clinical development strategies, acting as the primary liaison between the assigned therapeutic area and key stakeholders to ensure translation of the development plan into operational deliverables. Contribution to the scientific content of clinical program documents is a key deliverable and includes study synopses and protocols, Investigator’s Brochures, clinical study reports, conference abstracts, internal and external scientific meeting presentations and peer-reviewed publications.
Role that this position reports to Senior Director, Immunology
Main Responsibilities and Accountabilities
1 . Contribute to the compound's development strategy through provision of scientific input to clinical development strategies. This involves background research and literature analysis to review and evaluate clinical data in the generation of study concepts and protocols in the relevant therapeutic area and maintaining a high level of awareness of scientific developments and the competitive environment to assist on ongoing strategic re-evaluation of the program.
2. Coordinate and contribute to the therapeutic area (TA) activities required to develop and write documents under the relevant TA’s primary responsibility such as clinical development plans, clinical protocols (and supportive study documents) and regulatory submission documents.
3. Work closely with the Clinical Operations, Clinical Sciences, Data management, and Global Clinical Safety and Pharmacovigilance functions to ensure the translation of the protocol and clinical development plans into executable operational processes. Lead internal or external training as required and support the medical monitor in responses to investigators and other site personnel regarding clinical and study conduct questions.
4. Independently review study subject level data for presentation to the medical monitor for clinical decision making, throughout the study life cycle. Liaises closely with the clinical safety scientist or physician to support ongoing aggregate safety data review during clinical study.
5. May manage alone or in collaboration with clinical safety the operational functioning of data monitoring committees and/or clinical adjudication committees. Clinical Scientist may participate in and present at these meetings, as required.
6. Participate in analyzing and interpreting data from clinical studies, and writing/editing or reviewing results in study reports, regulatory submissions, abstracts, posters, presentations, peer reviewed manuscripts, and other documents. As required, lead internal data review meetings to determine strategic interpretation. May become a member of the company publication group. Additionally, serve as a scientific reviewer for company publications and external research proposals in the area(s) of expertise.
7. Participate in the Clinical Development and Clinical Operations teams. Provide support to the clinical development team (CDT) through meeting management support and communication. Act as the delegate for the CDT lead where required.
8. Manage the contractual and budget requirements for clinical strategy needs across programs including but not limited to consultants, data monitoring committees or adjudication boards.
Interact with internal auditing groups on a study level to ensure clinical development activities are conducted according to internal SOPs and work practices and in compliance with ICH-GCP.
9. Contribute to multidisciplinary work teams evaluating and implementing continuous improvement (i.e. quality circles, SOP harmonization, ACE).
Position Qualifications and Experience Requirements
- Advanced degree (MD, PhD, PharmD, or Master’s Degree) in life science/healthcare required with minimum of 5 years’ experience in clinical research., OR
- Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with > 10 years’ experience in clinical research.
- Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
- Strong research skills, knowledge of scientific analysis, data mining, and basic statistical analysis principles required.
- Experience in analyzing and presenting research results to scientific and professional audiences.
- Experience working in a cross-functional, matrix environment. Exposure to global multicultural teams desirable.
- Experience with the operational aspects of clinical trials and related activities such as investigator meetings, DSMB’s, and GCP/ICH are necessary.
- Excellent communication and presentation skills required. Experience in medical/regulatory writing preferable.
- Demonstrated experience in the development of biological molecules, proteins, and /or and medical devices a plus
- Good understanding of drug development process, strong knowledge of ICH/GCP.
- Ability to work successfully in a matrix organization and across multiple disciplines, including clinical, regulatory, pre-clinical, product development, statistics, pharmacology, medical writing and commercial management.
- Proven networking skills and ability to share knowledge and experience among colleagues.
- Fluent in English, oral and written.
- Bring a “can-do” attitude with a strong desire to identify problems proactively and propose solutions