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Director, Real World Evidence

Employer
CSL Behring
Location
Cambridge, Massachusetts
Start date
Aug 13, 2022

View more

Discipline
Science/R&D, Biostatistics, Research, Epidemiology
Required Education
Masters Degree/MBA
Position Type
Full time
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Job Details

Job Description

The Opportunity 

In a growing market of increase diversity, demonstrating the incremental real-world value of our products over competitor products is key, particularly in the context of NITAG engagement and driving vaccine recommendations and reimbursement. This Director RWE Science role is implemented to keep up with the increasing technical and methodological capabilities on Real world evidence appraisal, integration and translation of NITAGs and regulators. Expanded capacity and capabilities within Medical Affairs CORE in these areas will allow to anticipate the outcome of NITAG evaluations, adequately respond and maintain constructive dialogue with NITAGs and PHIs globally. The ‘evidence integration’ strategy is also a means to enhance and increase value of the evidence that is available. This would include consideration of all available data, (including RWE clinical trials), cross-functional collaboration with global and regional teams to understand data needs and gaps and develop response strategies.

With this role also comes leading as well as pproviding technical advice on Real world study design and analysis, liaising with external experts as required.

The Role 

Liaises with internal stakeholders including Global and Regional Medical Affairs functions, Market Access, Project Management, Clinical Development, Commercial, Regulatory Affairs, in a matrix environment for planning or to maximising the value proposition of late-phase or marketed Seqirus products according to strategic objectives. Represents CORE for relevant topics in the cross-functional forums. Subject matter expert that provides input to the Global Medical Strategic plans.

Oversees and ensures effective risk management for achieving objectives with the highest data quality possible at acceptable costs within budget and lowest possible risk for assigned research programs and projects. Oversee the quality and timely delivery of any work commissioned externally via CROs and consultants.

Provides and oversees the design and implementation of non-interventional studies and models whether conducted by Seqirus, or in working with external vendors and collaborators. Alternatively, to provide subject matter expert support in the design, (statistical) analysis and implementation of RWE non-interventional research programs and explore novel study designs, liaising with external experts as required. Critical reviews and provides appraisal of outcomes of RWE studies. Contributes to data synthesis, including systematic reviews and meta-analyses.

Where needed input to clinical development plans and research protocols () to optimise trial execution.

Manages compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA), World Health Organization, country and regional regulations for the reporting of adverse events to regulatory agencies.

Responsible for and contributes to the writing of relevant components of regulatory dossiers and product related documents (PSURs, RMPs etc.) through authoring and review of key sections for observational studies/epidemiological data and provide oversight to contributions from CORE as relevant.

In case of post-marketing commitments, to ensure that the response to such a commitment is effective and adequate. Provide advice on the epidemiological aspects of regulatory submissions. Remains current on standards for Good Epidemiology Practice and other standards within the biopharmaceutical industry related to compliance and best practices for conduct of epidemiologic studies.

Contribution to the interpretation and dissemination of real world and integrated evidence to support Seqirus products. Prepares or oversees the preparation of abstracts, posters, oral presentations and written reports to effectively communicate results of epidemiological programs and studies to internal and external stakeholders and colleagues with varying levels of epidemiologic research knowledge. Prepare manuscripts for submission to peer-reviewed journals. 

Represent Seqirus in meetings with health authorities and the scientific community, network with thought leaders, regulatory and international agencies for assigned topics and forums, interactions with vaccine advisory bodies, as required.

Fosters a leadership culture which attracts, develops and retains high calibre individuals with expertise in epidemiology capable of and committed to providing valuable and creative input to Seqirus projects to achieve or exceed company goals.

Your skills and experience 

  • MD or PhD or MS degree in Epidemiology or closely related health field (Biostatistics etc).

  • 10+ years progressive epidemiology research experience with at least 8 yrs in the Pharmaceutical or Biotech industry

  • Experience in the design, implementation, and analysis of prospective, field-based epidemiologic studies as well as retrospective analyses of large databases

Our Benefits 

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus. 

About Seqirus  

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus

We want Seqirus to reflect the world around us 

As a global organization with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus. 

Do work that matters at Seqirus! 

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

Do work that matters at Seqirus!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Find Us
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
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