Medical Affairs CORE Operations Manager

About CSL

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!

Job Description

As a member of the Medical Affairs CORE Project team, Centre for Observational Research and Evaluation (CORE), this position is responsible to manage the business processes to fulfill the mission of CORE to generate real-world data to scientifically differentiate Seqirus influenza vaccines. This position will lead the operational processes required for the execution of Phase IV studies. Accountable for tracking a complex portfolio of phase IV studies including cost, quality, timeliness and efficiency. This individual understands and articulates the mission and vision of CORE and facilitates the smooth cross-functional communication of the process and the scientific and medical strategy to drive innovation and differentiation. The CORE Operations Manager position is a central role within CORE project team, facilitating collaborative engagement with internal colleagues. This role will report to the Head of CORE.

Responsibilities include:

• Manage CORE, Medical Affairs initiatives cross functionally.
• Establish and manages operational processes to facilitate communication and collaboration cross-functionally within Medical Affairs, Clinical Development and other Research and Development (R&D) functions as well as specific Commercial teams, Corporate. Affairs and Legal.
• Organize and coordinate the internal Phase IV Committee meetings to ensure cross-functional alignment across the entire Phase IV space and gather scientific input on study designs, interpretation and distribution.
• Manages and produces monthly/quarterly cross-functional research meeting agendas and key take away action points.
• Oversee the internal operational processes required for the execution of Phase IV studies
• Manage operational execution of phase IV research that includes Seqirus led phase IV studies, phase IV studies Co- led with external investigators and Investigator Initiated Research (IIR).
• Will manage contracts, track study milestones, and provide updates communicated cross functionally.
• Ensure that study milestones are met on time and in accordance with regulatory, legal and quality requirements.
• Tracks CORE phase IV study budget and costs; ensures spending is on track, providing MA Operations Manager and MA Leadership with accurate monthly updates on spending.
• Contribute to development of guidelines documents and track key performance indicators and Metrics to document performance and impact.
• Contribute to SOP development, improved processes and training to ensure compliance with relevant industry regulations and guidelines.
• Manage external data dissemination and communication.
• Organize and coordinate External Scientific Advisory Board meetings to seek input and share design and execution of real world, phase IV studies.
• Collaborate with MA Operations to support CORE and MA leadership in operational planning and execution of Advisory Boards and Symposia to communicate real world evidence and to maximize product differentiation.
• Work closely with MA Publications manager to ensure study results are communicated internally and externally through posters, presentations and published manuscripts.
• Register and maintain phase IV research protocols for Seqirus in Pharmacovigilance Safety Master File (PSMF) and on public disclosure platforms.
• Provides optimal oversight of the operations of the CORE Investigator Initiated Research (IIR) Projects.
• Manage IIR committee including IIR applications for review and approval of CORE IIRs submissions
• Manage budget and financial oversight of CORE IIR projects
• Monitor study milestones, study reports, related publication, and external communication.
• Collaborate with MA Operations to align on management of regional and country IIR process

Qualifications, Experience and Competencies:

• Master's degree in science related field
• Post graduate degree in a life science field desirable
• 4 - 6 years work-related experience required in pharmaceutical or scientific setting
• Experience in the vaccines or drug development phase III, phase IV research setting desirable
• The ability to project manage a complex portfolio of phase IV studies and a demonstrated ability in strategic thinking to properly influence senior leadership and third-party vendor management.
• A high level of confidence, integrity and hands on approach to problem solving are required as well as a professional executive presence for interacting with and influencing senior management internally.
• Must be flexible and demonstrate strong judgment/decision-making skills and political acumen.
• Excellent organizational, verbal and written communications skills, as well as project management, analytical, planning and presentation skills are required.
• Experience in communicating technical data both internally and externally
• Knowledge of health care financing and delivery is desirable
• Experience working in a matrix team environment is required
• Ability to work effectively in a constantly changing and diverse environment
• Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel)