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Astellas Pharma Executive Director - M&D Real World Analytics in Northbrook, Illinois

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

This position will provide vision, leadership and strategic direction for M&D Real World Analytics (M&D RWA) globally. Working side by side with the Biostatistics groups, it will interface with various teams (including IEGP teams, GPSTs, CMTs and GVTs who own the Real World Evidence (RWE) strategy) to develop appropriate RWE generation approaches to meet the evidentiary needs of Astellas, and oversee RWE study execution that meets these identified needs with quality, agility and efficiency.

While the tactic ownership stays with the functions (ie. MA, Dev), the Executive Director M&D RWA is accountable for all analytical aspects (i.e. any form of data analysis, statistical analysis, data mining and artificial intelligence) and state-of-the-art methodology related to the generation of RWE across geographic regions and M&D functions, at portfolio, project, and protocol level. Generated RWE will be used internally and externally to support clinical trial design, regulatory approval, launch, market access and pricing, and other identified stakeholder needs.

As a member of the Medical Affairs Committee (MA-C) the Executive Director M&D RWA provides strategic and quantitative direction to ensure the MA-C is able to consider the risks and likelihood of success of the tactics considered. The role will also interface with the Global Development Committee (GDC) and Medical Affairs Protocol Approval Committee (MA-PAC) as required to optimize the design and approval of RWE tactics considered at these forums.

In addition, the purpose of M&D RWA is to centralize all RWE for a compound/indication/TA and all methodological, regulatory, capability-building and training aspects related to RWE, ensuring that Astellas is optimizing the development of its pipeline while maximizing the potential of these products through the innovative collection and/or use of Real World Data (RWD).

Essential Job Responsibilities:

  • Drive the M&D RWA vision. Serve as point of contact and represent M&D RWA in RWE-related activities across Astellas including the MA-C, GDC and MA-PAC. May interact with regulatory agencies, HTAs and payers to effectively address statistical questions and requests related to RWE.

  • Drive the M&D RWA vision. Serve as point of contact and represent M&D RWA in RWE-related activities across Astellas including the MA-C, GDC and MA-PAC. May interact with regulatory agencies, HTAs and payers to effectively address statistical questions and requests related to RWE.

  • Ensure scientific rigor and compliance with relevant guidelines when designing non-interventional studies and serve as methodology expert for RWE data analyses across various data types and applications including:

  • Retrospective analysis of RWD such as medical claims, electronic health records, chart reviews and registries -- including treatment patterns and drug utilization

  • Statistical aspect of the design and analysis of non-interventional prospective observational studies, pragmatic trials and epidemiological studies

  • Collaborative Research

  • Implementation of Integrated Evidence Generation Plan (IEGP)/Early Data Action Plan (EDAP) tactics (study statistical design and analysis)

  • Use of RWD to enhance clinical trials design, execution and interpretation -- including assessment as to whether a proposed clinical trial is feasible as described in the protocol (based on inclusion/exclusion criteria).

  • Identify trends, emerging patterns and stakeholder expectations in the application of RWE to support regulatory approvals, HTA assessments and payer requirements.

  • Promote and implement innovative methods, technologies, collaborations and tools to maximize the value of RWD.

  • Oversee the translation of research questions into well designed RWE studies, innovative and methodologically robust analysis plans, and compelling analysis/interpretation in close collaboration with key global and regional M&D functions and interfacing teams.

  • Build a rapid response team able to manage ad hoc requests with speed, flexibility and quality.

  • Develop and maintain efficient and fit-for-purpose RWE generation processes, SOPs and tools, in compliance with applicable guidelines.

  • Participate in the development and presentation of training on RWE-related topics.

Collaboration

  • Establish effective communications and partnerships with cross-functional and cross-regional groups such as Medical Affairs, TAs, Data Science Biostatistics, Clinical Science, PV, CPED, HEOR, Market Access, CMT and IEGP teams to support the development and execution of RWE strategies and tactics from post CN till launch.

  • Closely partner with Biostatistics to support the use of the totality of data across the product lifecycle.

  • Selection and qualification of vendors supporting M&D RWA will be done in collaboration with the tactic owner.

  • Collaborate with AIA to coordinate the acquisition of external Real World Data (RWD) data licenses, medical coding and data standards.

Leadership

  • Hire, retain and develop a global team of industry leading RWD professionals. Given the scope of this group, these professionals may have diverse backgrounds (e.g. Epidemiology, Analysts, Statisticians, Bio-informaticians, Computer scientists, Medical background, HEOR, Pharmacovigilance, Early Development, Economics)

  • Manage and oversee outsourcing, vendor and partnership management activities to drive delivery to key milestones, compliance, budget and expected quality.

Quantitative Dimensions:

This role will have accountability for the feasibility and execution of RWE studies within Astellas M&D; it will therefore have a direct impact on Astellas' pipeline from CN through post-launch through its vital role in ensuring the execution of high quality and timely evidence generation that directly addresses payer/HTA, regulator and other external stakeholder needs.

The role will also have a direct impact on M&D studies (design and execution) and clinical development plans as RWD will be leveraged to complement, enhance or accelerate clinical trials.

In addition, the role will raise Astellas external recognition through leadership in the RWE space and representation at key public policy and health data initiatives, committees and conferences across the globe.

Organizational Context:

This position reports to VP Biostatistics and Statistical Programming. The position will be responsible for a group of 20-30 professionals, spread across multiple geographies to support their business partners.

Qualifications:

Required

  • Master's degree in quantitative science (e.g. Statistics, Health Informatics, Econometrics, Mathematics), Health Policy or Epidemiology.

  • At least 15 years of pharmaceutical industry/biotech/CRO/academia experience specifically in human drug development

  • Prior leadership position in pharmaceutical development, HEOR, analytics, product strategy or similar function with line management responsibilities for at least 5 years.

Technical Expertise

  • Expertise in the statistical analysis of RWD such as claims data, registries and electronic healthcare as well as visualization of healthcare data

  • Advanced knowledge of epidemiologic methods and/or outcomes research (such as propensity score analysis and marginal structural modeling), and the application of retrospective and prospective observational studies to generate RWE

  • Excellent understanding of key drug development processes and strategies including clinical, regulatory, scientific, operational and commercial aspects of drug development

  • Knowledge of compliance, privacy, regulatory and safety pertinent to real-world data analytics

  • Understanding of RWD landscape across geographies and familiar with market-specific data and evidence requirements.

Leadership

  • Demonstrated ability to lead independently, translate strategic plans into goals and objectives for their own function and effectively prioritize own group's activities, in line with broader strategic company and product objectives and requirements

  • Strong influencing skills and ability to collaborate in a matrix organization, with proven ability to work and develop strong partnership cross-functionally

  • Proven ability to establish operating guidelines and procedures in a global setting

  • Demonstrates personality traits and values to be successful in the role, such as strategic thinking, integrity, collaboration, commitment.

Preferred

  • DrPH or PhD in quantitative science (e.g. Statistics, Health Informatics, Econometrics, Mathematics), Health policy or Epidemiology

  • Proven record of interactions with health authorities, HTAs and/or payers

  • Demonstrated history of presenting and publishing on the evolving health data landscape and how emerging data sources support enhanced drug development

  • Competency and/or awareness of standard statistical software such as SAS, R, Python and/or database programming language such as SQL

  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

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Category Data Science

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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