Associate Director, Epidemiology and RWE Sciences

Title:

Associate Director, Epidemiology and RWE Sciences

Company:

Ipsen Biopharm Ltd

Job Description:

Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.

The Associate Director, Epidemiology and RWE Sciences will support pre- and post-launch evidence generating activities across the entire product portfolio (Neuroscience, Oncology and/or Rare Diseases). The role will be responsible for designing, reviewing and supporting the execution of evidence generating activities using primary and secondary data.

The role will partner with internal stakeholders across the Development, Medical and Pharmacovigilance to produce research that is medically relevant, scientifically robust and meets Ipsen’s commitment of providing Innovation for Patient Care.

The role will be responsible for methodological epidemiological & RWE leadership and will contribute the development of new SOPs and guidance documents that will promote and ensure timely and high-quality, “fit-for-purpose” evidence generation. The role 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.

Main responsibilities / job expectations

Evidence Generation

• Partner effectively across the enterprise to support the identified evidence needs across Neuroscience, Rare Diseases, and/or Oncology 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;
• In partnership with the Asset Teams, drive the RWE strategy per asset as part of an integrated data and evidence generation plans;
• Design 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 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 assessment of external licensing opportunities by providing timely disease population assessments;
• Partner with Clinical Development teams to provide Epi support for study design and planning activities;
• Develop and adopt robust, fit-for-purpose data generation and analytic methodologies that advance research goals across different life cycle management stages;
• Develop and review study protocols and statistical analysis plans in collaboration with Biometrics, HEOR, Medical and other internal stakeholders;
• Stay informed and involved on the latest regulatory and methodological advances that expand and enhance the utility of RWE;
• Educate and raise the awareness around epidemiologic methods and 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;
• Actively participate in review of study proposals;
• 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 organisations, in close continuous partnership with Medical Asset and Therapy Area Leads.

Collaborate with internal Ipsen stakeholders on all topics around 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
• Ensure Ipsen can provide comprehensive patient focussed data & analytics in the disease areas we serve
• 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 maximise data availability, ensure patient impact and effective execution of RWE programs
•  Establish end-to-end best practices for data generation and sharing (policy, SOP, Legal, Privacy, etc.)

Education, Experience and Technical Competencies

Education / Certifications:

• Advanced degree in Epidemiology or related fields

Experience:

• At least 5 years of biotech/pharmaceutical 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 strong 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, 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
• Applies emerging knowledge and trends; builds strong relationships; contributes to expertise within and beyond assigned area
• Links responsibilities with the mission of the organisation; focusses on activities that add most value

Languages:

• Languages: Fluent in English, Competent in Medical Terminology

Key Organizational Competencies Required

• Demonstrated ability to collaborate in a matrix 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 prioritise and delegate work

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.