Senior Epidemiology Director in Northbrook, IL

$200K - $250K(Ladders Estimates)

Astellas Pharma US, Inc   •  

Northbrook, IL 60062

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 57 days ago

This job is no longer available.

Description

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company. Astellas is announcing a Senior Director, PV Epidemiology opportunity in Northbrook, IL.

Purpose & Scope:

The Senior Director, PV Epidemiology, contributes to the strategic leadership of the PV Epidemiology function within the PV Division at Astellas. The Senior Director makes key contributions in the following areas: development and execution of PV Epidemiology functional strategy, strategic leadership and implementation of non-interventional post-authorisation safety study (NI-PASS), process excellence, and driving innovation in the value-added application of Epidemiology in PV and M&D.

Essential Job Responsibilities:

The PV Epidemiology Group Mission is to use epidemiological expertise in PV to (1) Lead development of non-interventional post authorization safety studies for regulators, (2) Generate/identify/summarize scientifically sound epidemiological evidence for Regulatory submissions and PV deliverables (eg for RMPs, SERs, ODAs, PIPs), and (3) Collaborate, Consult and Innovate. The PV Epidemiology Vision is to bring our unique epidemiologic skills to gain rapid insights from real-world data to increase efficiencies and drive innovation in pharmacovigilance and drug development for the betterment of patients. The Senior Director in PV Epi plays an important role in aiding PV Epidemiology to deliver on its Mission and realize its Vision. The individual has a key responsibility for:

  • Contributing to the strategic focus for pharmacoepidemiology and healthcare database insights & studies to support portfolio- and product-related regulatory-associated questions in both the pre- and post-marketing setting
  • Taking a lead on more complex regulatory-orientated NI-PASS
  • Providing methodological expertise in observational research to PV and partners across M&D
  • Supporting delivery of high scientific quality, cross-portfolio Epidemiology deliverables
  • Developing and implementing strategies to assess & optimize product safety using Real World Evidence
  • Utilizing advanced pharmacoepidemiology tools and methods for safety signal investigations
  • Driving PV Epidemiology innovations in partnerships, deliverables and methodological approaches
  • Ensuring that Epidemiology activities comply with regulatory obligations worldwide
  • Playing a leadership role in PV and M&D, including contributing to & potentially leading change initiatives
  • Identifying new opportunities to bring state-of-the-art epidemiology developments to our company work in developing new products and in ensuring appropriate use of our products for value to patients
  • Working closely with senior-level partners to lead and deliver on the above activities, including the Executive Director PV Epidemiology, other PV Epidemiology staff, top management in PV including Head of PV and other Pharmacovigilance Committee members, TA and Product PV Medical Safety Leads, the Office of the EU-QPPV and Japan Safety Control Officer, staff in Safety Science (Risk Management, Signals, Aggregate Safety Assessment) and Others.

Quantitative Dimensions:

This position's impact can be measured across the following dimensions, by ensuring:

  • PV Epidemiology activities comply with regulatory obligations worldwide, working closely with the Executive Director, and the Offices of the QPPVs (EU, Japan)
  • High scientific quality and consistency of epidemiologic input into pre- and post-approval activities, including NI-PASS
  • Efficient and effective logistics and operations, and smooth and timely epidemiology-focused input and deliverables
  • This position adds strategic value to the success of drug development programs and to life-cycle management, through delivery of high regulatory-quality evidence-generation activities
  • This position provides added-value as a key partner for the Medical Safety function, which is responsible for signal evaluation at a product level across the portfolio

Organizational Context:

  • Reports directly to the Executive Director, Head, PV Epidemiology, together with other Epidemiologists (at Associate Director and Director levels)
  • Senior member of PV Epidemiology functional team
  • Mentors senior scientific staff and contractors; no direct reports
  • Interacts and collaborates with peers in PV, including in Signals, Risk Management, Aggregate Safety Assessment, Medical Safety, QPPV Offices
  • Interacts and collaborates with staff across M&D (including Medical Affairs, Development, and Regulatory Affairs) and Astellas (including RWE in Advanced Informatics & Analytics)
  • May lead PV Epi-related (study) activities in matrix teams, notably Core Teams, Core Medical Teams, and Benefit-Risk Teams, and at governance committees, eg MAC and MA-PAC

RequirementsQualifications:

Required:

  • PhD in Epidemiology or related field (or equivalent, eg 1st author scientific publications)
  • At least 10 years pharmaceutical/health-related industry experience; at least 10 years Epidemiology research experience
  • Key leadership responsibilities in previous roles, with evidence of success
  • Proven strategic leadership in epidemiology and NI-PASS
  • Sophisticated understanding of quantitative methods and outstanding ability to interpret and communicate quantitative evidence
  • Extensive working knowledge of PV regulations and guidelines, including US, ICH and EU regulations
  • Delivers quality proposals, scientific protocols, reports and input
  • Experienced problem-solver, explores alternatives, and proposes quality solutions
  • Excellent English-language skills, spoken and written
  • Ability to work and influence effectively in teams, across cultures and functions, and at all levels including top executive management

Valid Through: 2019-9-16