Senior Manager, Epidemiology & Real World Evidence Sciences

Title:

Senior Manager Epidemiology & Real World Evidence Sciences

Company:

Ipsen Pharma (SAS)

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

For more information visit us at follow our latest news on LinkedIn and Instagram.

Job Description:

At Ipsen we choose to focus on what matters most. Patients. Progress. Partnership. Yes.

We are looking for a Head of Safety Partnering to define and lead our global pharmacovigilance partnering strategy across a diverse commercial portfolio. This is a pivotal leadership role at the heart of how we collaborate ensuring that strong partnerships translate into safe compliant and impactful outcomes for patients worldwide.

Why this role matters

The Senior Manager Epidemiology and RWE Sciences will work closely with the Director Pharmacoepidemiology & Patient Centered Outcomes to support pharmacoepidemiologic and various evidence generation activities across the entire product portfolio (Oncology Rare Diseases and Neuroscience).

You will:

• Oversee generation and explanation of epidemiologic data across the business supporting the design of evidence generating activities using primary and secondary data management of epidemiologic benefit-risk evaluations in partnership with the safety team and support for analytics related to various evidence generation activities across the Epi and RWE team as neede
• Partner with internal stakeholders across the Asset Team to ensure the availability of robust epidemiologic data and produce data that is medically relevant scientifically sound and meets Ipsens commitment of providing Innovation for Patient Care.
• Be responsible for methodological epidemiological & RWE leadership that will promote and ensure timely and high-quality fit-for-purpose evidence generation.

Main responsibilities

Epidemiology Support

• Support External Innovation and Business Development teams in the assessment of external licensing opportunities by providing timely disease population assessments.
• Lead and support the development of epidemiologic and real-world evidence assessments to address key business development regulatory safety and market access questions across the product lifecycle.
• Coordinate and contribute to integrated Benefit-Risk (BR) assessments by synthesizing epidemiology natural history data clinical trial data real-world evidence safety information unmet need and patient context to support strategic decision-making.

Project Management/Administrative Support

• Support the coordination and execution of epidemiology data requests and Benefit-Risk (BR) assessments contributing to evidence generation activities and ensuring timely delivery of high-quality scientific outputs.
• Collaborate with internal stakeholders external vendors consultants and research partners to support epidemiology assessments evidence syntheses BR evaluations and related projects.

Collaborate with Internal Ipsen Stakeholders on All Topics around Epidemiology & RWE

• Collaborate with cross-functional stakeholders (GPS HEOR Regulatory Clinical Development Medical Affairs External Innovation and affiliates) to support EpiCenter requests and Benefit-Risk (BR) assessments.
• Contribute to scientific deliverables including epidemiology assessments BR reports regulatory documents conference presentations abstracts and publications.
• Support the integration of epidemiologic evidence real-world data and literature findings into strategic regulatory safety and business decision-making.

Qualifications

• Extensive experience in Epidemiology or Observational Research including experience within the biotech or pharmaceutical industry.
• Knowledge of medical regulatory and payer systems in one or more regions of the world.
• Strong 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.
• Proficiency in statistical software and analytical tools (R SAS SQL or equivalent)
• Extensive experience working with large healthcare databases and real-world data sources.
• Advanced degree (Masters MPH PharmD PhD or equivalent) in Epidemiology Public Health Biostatistics or a related quantitative health science discipline.
• Additional training or demonstrated expertise in epidemiology real-world evidence (RWE) observational research or pharmacoepidemiology is preferred.
• Fluent in English.

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