Associate Director, Epidemiology JAPAC

The Global Epidemiology team within PSEQ (Pharmacovigilance [PV], Patient Safety, Epidemiology & Quality) collaborates strategically with cross-functional colleagues across the product lifecycle to identify, evaluate, generate, and communicate evidence specific to diseases of interest to AbbVie or relevant in characterizing the benefit-risk profile of our medicines derived from observational research or real-world data (RWD) studies.

This position reports into the Evidence & Partnerships team of epidemiologists and data scientists within Global Epidemiology that provides expert advice on RWD strategy and evidence generation.

The Associate Director, Epidemiology JAPAC collaborates with Intercontinental Regional Area (“Area”) as well as Affiliate teams—teams include Global Medical Affairs (Area or Affiliate Medical Leads), Area Evidence Generation teams, Affiliate Evidence Solutions Groups, PV, Safety, and additional Development, Medical, and Market Access stakeholders. The Lead will be a strategic partner and advise on planning and design of key epidemiology and RWD studies. The Area/Affiliate collaboration with Global Epidemiology is designed to contribute to the successful product launches by anticipating critical evidence needs, bring local subject matter expertise for engagements with regulatory agencies for safety studies (PASS) that may have an impact on the global benefit-risk profile, and support the value and differentiation of AbbVie’s products in Area and key Affiliates.

The Associate Director, Epidemiology JAPAC will report into the International Alliance Director (and headquarters), and align with global corporate strategic priorities set forth by headquarters. The Associate Director, Epidemiology JAPAC will engage with Area and Affiliate teams, leveraging existing connections such as the International PV and Area Evidence networks to bring expertise to strategically enable consistent and high-quality evidence that may be generated by the regional and affiliate teams.

Responsibilities

• Act as subject matter expert, knowledgeable in pharmacoepidemiology principles of study design, providing meaningful input for practical and fit-for-purpose approaches to addressing real-world evidence gaps for Area and Affiliate teams to support successful launch and commercialization of AbbVie products.
• Experienced in drug development and provides relevant or creative strategic advice on disease epidemiology or real-world safety evidence to support of key decisions and emerging topics in post-marketing data for recently launched products or products with heightened external safety interest.
• Has a strong understanding of the evolution of guidelines for building regulatory-grade real-world evidence (in safety and effectiveness) to support of new indications or drug approvals—focused on regulatory authorities in key markets globally including China and Japan.
• Understands and communicates on the role of epidemiologists at AbbVie in signal evaluation, and where Global Epidemiology contributes to key safety and regulatory deliverables.
• Works with Area/Affiliate teams and International PV Network to proactively gather insights on regulatory and commercial strategies for late-stage assets and provide epidemiology and PV perspectives. Evaluates impact of these strategies on risk management planning and PV deliverables/activities. Supports International PV Network and PSEQ when necessary to share relevant information and ensure readiness to support strategies.
• Works within Global Epidemiology—specifically, TA and Asset leads, as well as the Pharmacoepidemiology Center of Excellence, and Disease Epidemiology & Forecasting teams--to triage and translate critical Affiliate real world evidence gaps, reinforcing communication and prioritization and alignment between global and Area/Affiliate teams.
• Reviews observational research protocols proposed for the region or Affiliates in diseases of interest to AbbVie. Serves as a pharmacoepidemiology, real-world evidence study design expert, providing input to affiliate teams to drive consistent and appropriate use of epidemiological and real-world data, evaluating clinical applicability and any technical or statistical issues related to use of such data and its combination with other datasets.
• Demonstrates creativity and independent thought in applying strategic advice on technical solutions to derivation of epidemiologic inputs for key affiliate needs.
• Communicates on the value and appropriate use of real-world evidence within the company and provides expert interpretation of such studies. Able to distill insights from epidemiological and real-world evidence studies to cross-functional and leadership teams that contribute to Area and Affiliate strategy and portfolio decisions.
• Contributes to R&D cross-functional initiatives, representing Global Epidemiology as well as area and affiliate perspective as needed in data strategy related discussions. 
• Works with peers within Global Epidemiology as well as with cross-functional teams to evaluate data opportunities from health records, insurance claims, registries, genomic or other real-world datasets in specific disease areas to determine suitability for building affiliate level insights into relevant patient populations—bringing forward opportunities that may support not only regional and affiliate level but also global priorities.
• Establishes and reinforces collaborations with academics, registry-based scientists, consortia, healthcare providers, and opinion leaders to initiate epidemiological studies and for access to data pertinent to the region or affiliates, thereby contributing to the overall clinical evidence strategy.
• Participates or presents in professional society or policy group forums focused on real-world evidence for safety or effectiveness related regulatory decision-making, as well as AbbVie-sponsored advisory boards and opinion leader meetings as needed.

• Minimum: Either MPH or MS with 7 or more years of demonstrated epidemiological experience in biotech/pharma; or MD/PharmD/PhD with 2 or more years of experience in the field of epidemiology, outcomes research or related discipline.
• Experience working for a pharmaceutical or biotechnology company leading epidemiological research, including design and conduct of post-authorisation safety studies (PASS)
• Experienced in development of new evidence through study design, protocol development, and statistical analysis plans. Experience in independently leading and conducting epidemiological research using large datasets such as health records or claims databases. Expertise in the interpretation of observational research and awareness of the limitations and challenges of working with these datasets to advance scientific knowledge. Experienced in establishing productive collaborations with internal stakeholders, external investigators and corporate partners as a team leader.
• Preferred: Experience within a pharmaceutical or biotechnology company leading genetic epidemiological research, incorporating biomarker/genomics data analysis experience.
• Preferred: Experience setting up external collaborations and conducting observational studies with local data in JAPAC.
• Preferred: Proficient in Mandarin (spoken and written).

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.