Senior Manager, Epidemiology & RWE Sciences

Senior Manager, Epidemiology & RWE Sciences

Ipsen Pharma

Cambridge, United Kingdom

Job Description:

Summary/Purpose of the Position:

The Senior Manager, Epidemiology and RWE Sciences will work closely with the Head of Epidemiology/RWE Science to support pre- and post-launch evidence-generating activities across product portfolios within a Therapeutic Area. The role will be responsible for managing integrated evidence-generation activities for specific products as well as designing, reviewing, and supporting the execution of evidence-generating activities using primary and secondary data, as relevant.

The role will partner with internal stakeholders across the Asset Team, including those in Research & Development, Medical, and Pharmacovigilance functional areas, to ensure the availability of robust epidemiologic data and produce research that is medically relevant, scientifically robust and meets Ipsen’s commitment of providing Innovation for Patient Care. The Senior Manager will also support providing relevant epidemiology and RWE support to Regulatory and Global Patient Safety teams.

The role will be responsible for methodological epidemiological & RWE leadership that will promote and ensure timely and high-quality, “fit-for-purpose” evidence generation.

Main Responsibilities/Job Expectations

Evidence Generation & Epidemiology Support:

• Develop and adopt robust, fit-for-purpose data generation and analytic methodologies that advance research goals across different life cycle management stages.
• Play a central role in driving the development of evidence generation plans and identifying strategies to address prioritized evidence gaps that contribute to the global Integrated Data and Evidence vision at Ipsen.
• Design prospective and retrospective pharmaco-epidemiology studies (including RWE studies) in the pre-/post-launch setting, including those related to Regulatory post-approval commitments.
• Conduct critical review of RWE/Epidemiology studies designed by internal teams and/or external service providers to ensure scientific robustness and alignment with strategic goals.
• 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 the assessment of external licensing opportunities by providing timely disease population assessments.
• Partner with Clinical Development teams to provide epidemiologic support for study design and planning activities.
• Stay informed and involved on the latest regulatory and methodological advances that expand and enhance the utility of RWE.
• Develop and review study protocols and statistical analysis plans in collaboration with Biometrics, Medical and other internal stakeholders.
• Educate and raise awareness around epidemiologic methods and RWE and its potential in supporting Ipsen’s internal teams to generate buy-in across the organization.

Project Management/Administrative Support:

• Actively participate in the review of study synopses, proposals and reports.
• Conduct feasibility assessment of relevant data sources for disease areas and research questions.
• Determine potential use of RWE historical control and/or external controls in support of clinical development programs.
• Collaborate with and manage vendors, to ensure meeting project timelines and goals.
• Provide seamless and consistent support to global and local franchises.
• Ensure linkage of 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 Epidemiology & RWE:

• Fully involve Ipsen stakeholders (GMA TAs, HEOR, GMA Clin Ops, GMPC, R&D and affiliates) in the design and implementation of the RWE framework utilizing strong communication skills.
• Contribute to company publications strategy via development of conference abstracts, presentations, peer-reviewed manuscripts based on the findings of RWE studies.
• Drive Medical, cross-functional, and global alignment to enable early strategic alignment of Medical Affairs Epidemiology and RWE 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.

Education, Experience and Technical Competencies

Education/Certifications:

• Advanced degree in Epidemiology or combination of PharmD combined with MPH.

Experience:

• Minimum of 6 years of relevant experience in Epidemiology or Observational Research, including at least 2 years within the biotech or pharmaceutical industry.
• Knowledge of medical, regulatory, and payer 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 strong familiarity with secondary data sources.
• Experience leading external analytic and evidence-generating activities.
• Excellent methodological and data analytic skills, including knowledge of standard statistical software & packages (SAS, R, etc.).
• Demonstrate ability to provide strong direct global project management/leadership skills.
• Exceptional critical thinking to help identify gaps, analyse findings, and make recommendations while articulating next steps.
• Possession of core strategy and analysis skills, as well as the ability to lead and influence others by acting as a strategic partner to medical leaders.
• Ability to apply emerging knowledge and trends; builds strong relationships; contributes to expertise within and beyond assigned area.
• Skilled in linking responsibilities with the mission of the organization and focusing on activities that add most value.

Languages:

• Fluent in English.

Key Organizational Competencies Required

• Competent in Medical Terminology
• Demonstrated ability to collaborate in matrixed and remote organizations.
• Ability to work, lead and thrive in a cross-functional team environment.
• Ability to work independently and as an active member within cross-functional teams.
• Demonstrated experience in innovative and design thinking.
• Cross-cultural awareness.
• Excellent verbal communication, written, interpersonal, presentation and influencing skills.
• Ability to prioritize work.

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