Global Medical Director - Pipeline

Employer
  • Seqirus

Job Description

Job Summary:

At CSL Seqirus, we are on the front line of fighting Influenza and we are now looking to go beyond the influenza.  Thinking big, working together and focusing on keeping people healthy are part of our core fundamentals. 

The Global Medical Director (GMD) reports to the Head, Global Medical Strategy (GMS). The GMD will work with Commercial, Regulatory, Clinical, Policy and Corporate Affairs to develop and execute the Launch plans for the pipeline and Life Cycle Management of the CSL Seqirus portfolio and will play a critical role in establishing and maintaining our scientific messaging for influenza and new therapy areas. The Global Medical Director (GMD) is responsible for developing and executing strong strategic global medical launch plans for pipeline vaccine in influenza and new therapy areas beyond influenza, providing decision-makers around the world with the evidence and confidence they need to scientifically differentiate our vaccines, in alignment with the rest of the portfolio.

The Role:

  • Develop a comprehensive medical strategy/ launch plan for the pipeline vaccines as a matrix leader with a cross functional team. The medical strategy involves comprehensive development of the data and perception gaps in key markets, the strategic medical objectives and tactics to address the data and perception gaps to enable successful prelaunch and launch activities in the key countries. The GMD will provide medical insight, scientific expertise and medical leadership. The GMD will oversee and provide hands on support as a partner to the Commercial Development Senior Director, New products planning and to the cross functional team to drive and participate in key strategic decisions that impact the launch planning of our vaccines in influenza and new therapy areas in Vaccines. The GMD will be the Medical Lead on the product specific Global Product Lead Teams (GPLT) to help the GPLT understand the current recommendations from NITAGs and how the pipeline vaccine will be positioned based on the clinical data and inform the Real-World Evidence Plans where there may be data gaps.

  • Provide medical leadership to the Portfolio Strategy Teams (PST)/Clinical Project Teams (CPT). The GMD will serve as subject matter expert providing medical support to Regulatory and Clinical teams in regulatory submissions and clinical programs for pipeline products, including participating in regulatory authority planning meetings. This involves proactively understanding the therapy area, collating feedback from the regional/ country medical affairs teams in parallel with commercial development to inform the decisions around clinical development strategy and Target Product Profile.  

  • Drive the scientific understanding of the platform, therapy area with Corporate Affairs on pipeline and associated therapy area: the GMD will be the lead medical professional in providing scientific and medical expertise to develop positioning, key messages and Q&A for major milestones and issues in global -related matters. The GMD will be responsible for the development of a scientific narrative and ensure compliance as required for any new platform technologies.

  • Be the medical lead in the deep understanding of the therapy areas, current vaccines in development and how the vaccine under evaluation compares against existing and new vaccines. This will add expertise to Business Development colleagues leading discussions with external parties in regards to our pipeline/ new therapy areas, and provide input/ medical and scientific thought leadership for the final evaluation of the new vaccine under consideration

  • Be a matrix leader and will work collaboratively with Regional Medical Affairs team on shaping pre-launch/launch environment, shaping activities and provide scientific input into medical submission to NITAGs as required 

  • Represent CSL Seqirus to external collaborators which involves interface with the scientific community either through direct/virtual interaction and establish relevant relationships with government officials and external experts to enable gathering of insights, exchange knowledge and inform CSL Seqirus medical strategy. The GMD will identify gaps in knowledge from the wider teams across CPT and GPLT, where the external insights is warranted for key decisions with CSL Seqirus Governance process in the clinical development and launch plans. The GMD will be asked to lead the external congress symposiums in major congresses either on their own or as part of a wider medical team in collaboration with country Medical Directors.

  • Work closely with the Head, Global Medical Strategy and other Med affairs team members in global function such as publications, Centre for Outcomes Research and Epidemiology (CORE) to ensure there is alignment between Medical Strategy and Publications and RWE strategy for the pipeline vaccines. The GMD will be expected to understand the CSL Seqirus portfolio and pipeline and provide support and help in the Seasonal vaccine Portfolio as required. The GMD will deputise for the Head, GMS, their absence when required.

  • Work as part of the wider team in Global Medical Strategy to identify and evolve organizational processes towards the medical affairs overall vision and mission to support the CSL Seqirus 2030 strategy. There may be other jobs and responsibilities which are identified from time to time.

Minimum Requirements:

  • B.S. degree in medicine or biomedical or allied medical discipline, complemented with post-graduate qualification and experience in the pharmaceutical/ biotechnology industry field.

  • 10+ years pharmaceutical/biotherapeutics industry/academic experience with extensive knowledge and experience of product development/launch planning in relevant therapy area

  • 5-7+ years in medical affairs with some experience of Regional/Global role

  • Sound experience interacting with commercial and other cross functional teams within the healthcare industry

  • Extensive and proactive commercial awareness with evidenced application to regulatory strategies

  • Demonstrated ability to provide medical leadership and influence stakeholders

  • Ability to establish credible relationships within CSL Seqirus and externally, including external experts/ KOLS/ healthcare professionals, professional associations and other key stakeholders

Our Benefits

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