Director, Real World Evidence - North America - Remote Role
Posted on: June 25, 2022
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 OpportunityAs 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
- 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
- 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
- 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/
- 10+ years of progressive Real World Evidence experience or
closely-related function; managing complex programs and
- 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
- Extensive knowledge of the applicable regulation of
- People management skills and leading high-performing
- Experience in representation in global scientific, industry,
and regulatory forums.
- Experience in administration of complex data setsOur
BenefitsSeqirus 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 SeqirusSeqirus 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
We want Seqirus to reflect the world around usAs 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 BenefitsSeqirus 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 SeqirusSeqirus 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 usAs a global organization with employees in 35+ countries,
CSL embraces diversity and inclusion. Learn more about Diversity &
Inclusion at Seqirus.Do work that matters at Seqirus!Watch our 'On
the Front Line' video to learn more about Seqirus
Keywords: Seqirus, New York , Director, Real World Evidence - North America - Remote Role, Executive , Summit, New York
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