Head of Epidemiology and Real World Evidence (RWE) Sciences

Location
Cambridge, MA, United States
Posted
Jun 04, 2021
Ref
R-07658
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Head of Epidemiology and Real World Evidence (RWE) Sciences

Company:
Ipsen Bioscience, Inc.

Job Description:

Are you experienced working in epidemiology with an interest in real world evidence generation?

As Head of Epidemiology and Real World Evidence (RWE) Sciences you will be tasked with building a scientific research-based organization responsible for supporting the pre- and post-launch evidence generating activities across the entire product portfolio (Oncology, Rare Diseases and Neuroscience). As a member of Global Medical Affairs you will provide leadership and execution of Epidemiology and Real World Evidence programs that support the evidence needs for pipeline and marketed products while partnering with internal stakeholders across the company to produce research that is medically relevant, scientifically robust and meets Ipsen's commitment of providing Innovation For Patient Care. Additionally, you will also partner with external partners and thought leaders to develop and shape evidence generation strategies using observational and interventional study designs and a broad range of data types (EHR, administrative claims, registries, etc.)

The Head of Epidemiology and RWE will be responsible for methodological epidemiological & RWE leadership and will contribute the development of new SOPs and guidances that will promote and ensure timely and high-quality, “fit-for-purpose” evidence generation. While playing a central role in supporting Epidemiological needs across the product life-cycle, including supporting the design and planning of development programs, assessing background safety and natural history of diseases, as well as evidence generating activities in support of post-approval regulatory commitments and broader life-cycle-management needs you will be a key contributor and advocate for designing and implementing the Integrated Data and Evidence strategy that brings to the forefront outcome centricity for better patient care.

Your role will involve:

Evidence Generation
  • Partner effectively across the enterprise to identify evidence needs across Oncology, Rare Disease and Neuroscience and play a central role in designing evidence plans and strategies that address evidence gaps and contribute to the global Integrated Data and Evidence vision at Ipsen
  • Collaborate cross-functionally to lead the development of evidence generating strategies and approaches across the product life-cycle and in support of internal and external stakeholders;
  • Lead the design and execution of prospective and retrospective pharmaco-epidemiology studies (including RWE studies) in the pre-/post-launch setting, including related to Regulatory post-approval commitments;
  • Conduct critical review of RWE/Epidemiology studies designed by external service providers and from external publications, as well as regulatory document sections and other relevant documents
  • Ensure the fulfilment of timely, high-quality epidemiology/RWE sections of Regulatory documents for agencies worldwide, including submissions, RMPs, breakthrough or orphan designations, advisory committee briefing books, etc.
  • Support External Innovation and Business Development teams in assessment of external licensing opportunities by providing timely disease population assessments;
  • Develop and adopt robust, fit-for-purpose data generation and analytic methodologies that advance research goals in support of LCM;
  • Develop and review study protocols and statistical analyses plans in collaboration with Biometrics, Medical and other internal stakeholders;
  • Provide strategic support and epidemiological and programming expertise to design and conduct studies using primary and secondary data;
  • Actively participate in strategic discussions across the wider organization. Evaluate critically research/study proposals and summarize results for different audiences.
  • Educate and raise the awareness around RWE and its potential in supporting Ipsen's internal teams to generate buy-in across the organization


Administration
  • Provide budget input for activities related to Epidemiology and RWE studies and initiatives ensuring projects are adequately resourced
  • Provides seamless and consistent support to global and local franchises.
  • Ensure linkage of clinical study data and insights gathered from external experts including HCPs and patient organizations in close continuous partnership with medical asset leads and therapy areas


Collaborate with internal Ipsen stakeholders on all topics around RWE
  • Fully involve Ipsen stakeholders in the Design and implementation of the RWE framework, from design to communication
  • Ensure Ipsen can provide comprehensive patient focused data & analytics in the disease areas we serve.
  • Drive medical, cross functional and global alignment to enable early strategic alignment of medical affairs studies across global and local teams, in partnership with the Medical Asset leads, to ensure late phase data generation plans maximize data availability, ensure patient impact and effective execution of RWE programs
  • Establish best practice data sharing.


In return, you will bring:
  • Advanced degree in Epidemiology or related fields
  • At least 8 years of pharma experience in an Epidemiology or Observational Research role
  • Strong methodological and analytical skills
  • Knowledge of medical, regulatory, and payor systems in one or more regions of the world
  • Demonstrated experience in designing and conducting pharmaco-epidemiology studies in support of pre-/post-approval evidence generating activities
  • Expert in data collection methods and good familiarity with secondary data sources
  • Experience leading external analytic and evidence generating activities
  • Excellent data analytic skills, including knowledge of standard statistical software & packages (SAS, R, etc.)
  • Demonstrated ability to provide strong direct global project management/leadership skills
  • Exceptional critical thinking to help identify gaps, analyze findings and make recommendations while articulating next steps
  • Ability to apply emerging knowledge and trends; builds strong relationships; contributes to expertise within and beyond assigned area


If you are ready to make a difference in this impactful role, apply today!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.