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Associate Director, Epidemiology and RWE Sciences

Employer
Ipsen Biopharmaceuticals, Inc.
Location
Cambridge, Massachusetts
Start date
Jun 6, 2023

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Discipline
Science/R&D, Epidemiology
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Genetown

Job Details

Title:

Associate Director, Epidemiology and RWE Sciences

Company:

Ipsen Bioscience, Inc.

Job Description:

Associate Director, Epidemiology and RWE Sciences

Summary / Purpose of the Position

The Associate Director, Epidemiology and RWE Sciences will support pre- and post-launch evidence generating activities across entire product portfolios within a Therapeutic Area. The role will be responsible for helping map out integrated evidence generation activities for a product and then 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 Research & Development, Medical and Pharmacovigilance functional areas 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.

Main responsibilities / job expectations

Evidence Generation

  • Partner effectively across the enterprise to support the identified evidence needs and play a central role in designing evidence generation plans and strategies that address prioritized 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 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 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;
  • 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, 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 Leads and Therapy Areas.

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 and relevant 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, analyze 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 organisation and focusing on activities that add most value.

Languages:

  • Languages: Fluent in English, Competent in Medical Terminology

Key Organizational Competencies Required

  • 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 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.

Company

Ipsen (Euronext: IPN; ADR: IPSEY) is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen's North American operations and headquarters are located in Cambridge, Massachusetts, where our fully integrated biopharmaceutical team across External Innovation and Partnering, Research & Development (R&D), Manufacturing and Commercial collaborate. Cambridge is home to Ipsen's third global hub, in addition to R&D centers in Paris-Saclay in France and Oxford in the United Kingdom. With additional offices in Basking Ridge, N.J. and Mississauga, Ontario, Ipsen employs approximately 600 people in North America. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.

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Company info
Website
Phone
617-679-8500
Location
1 Main Street
Unit 700
Cambridge
MA
02142
United States

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