Director, Real World Evidence - North America - Remote Role

REMOTE -  This role is considered a remote position that is within a commutable driving distance to either our Summit, NJ or Waltham, MA offices to attend occasional in person meetings / events as required.

The Opportunity

As the Director of Real World Evidence, you are a member of the Centre of Outcomes Research (CORE) and Real World Evidence (RWE) organization and are offered the responsibility to provide strategic leadership and managerial oversight. You will support and define the strategic direction for the epidemiological and RWE research portfolio in line with Seqirus objectives and scientific narratives of the global product portfolio. The role works in a matrix environment and provides assigned external representation in scientific, industry, and regulatory forums.

The Role

• Design and add to the Global Medical Strategic plans and align objectives within the team to ensure optimal resource allocation.

• Contribute to the ongoing evaluation of the strategy and progress through participation in relevant committees.

• Liaise with internal stakeholders including Project Management, Clinical Development Commercial, and Regulatory Affairs to plan and maximize the value proposition of late-phase or marketed Seqirus products.

• Provide input and direction for the design and implementation of epidemiological studies, systematic reviews and models conducted by Seqirus, or external vendors and collaborators.

• Be the subject matter expert support to other functions in the design and implementation of epidemiological research programs.

• As needed input to clinical development plans and research protocols to optimize trial execution.

• Oversee and ensure effective risk management for achieving research objectives with the highest data quality possible at acceptable costs within budget and the lowest possible risk for assigned research programs and projects.

• Responsible for 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.

• Provide advice on the epidemiological aspects of regulatory strategy in support of the filing of INDs/CTAs and license applications throughout the development lifecycle.

• Oversee and contribute to the preparation of abstracts, posters, oral presentations, and written reports that effectively communicate the results of epidemiological programs and studies to internal and external stakeholders.

Your skills and experience

• Advanced degree (MD, PhD, DrPH or PharmD) within a relevant life science/healthcare or equivalent education/degree in relevant life science/healthcare with specific training in Real World Evidence and/or Epidemiological methods

• 8+ years of progressive experience within the pharmaceutical/ biotech industry

• 10+ years of progressive Real World Evidence experience or closely-related function; managing complex programs and designs.

• Experience with design, implementation, and analysis of epidemiological methods essential, including but not limited to infectious disease Real World Evidence, estimation of burden and impact, transmission models, observational research, including vaccine effectiveness research.

• Exchange of scientific and medical information including Advisory Boards and presentations at national and international meetings

• Extensive knowledge of the applicable regulation of observational studies.

• People management skills and leading high-performing teams.

• Experience in representation in global scientific, industry, and regulatory forums.

• Experience in administration of complex data sets

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! 

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.

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.

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