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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 .

Astellas is announcing a Associate Director, Computational Biology & ML/AI opportunity. 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:

The Associate Director, Computational Biology & ML/AI is responsible for providing computational biology, bioinformatics, data science (machine learning, deep learning), and statistical expertise to enable translational science at Astellas, an organization focusing in emerging areas of discovery research including regenerative medicine, mitochondrial diseases, immuno-oncology, and cell & gene therapies. This role will support advanced analytics execution for projects in discovery through early development phases of the drug development life cycle. This role will leverage scientific, technical and analytical skillsets to collaborate with Astellas stakeholders and external partners to innovate around therapeutic research questions and work with large, multi-dimensional datasets including areas using a variety of pre-clinical and real world data sources such as electronic medical records, insurance claims, patient registries, genomics, transcriptomics, proteomics, imaging (e.g., pathology slides, radioagraphy, patient-reported data), etc. across Astellas' geographic footprint and therapeutic areas.

This role will work closely with fellow TS-DSA team members, the Digital Research Solutions unit, the broader Advanced Informatics & Analytics (AIA) division, and the broader Astellas organization across the globe to execute large and/or complex data set builds, interact with cross functional teams, and be accountable for the analytical soundness of all project plans, output and deliverables for assigned projects.

This role will collaborate closely with discovery and early development functions within Astellas, therefore this role must be comfortable integrating with multidisciplinary teams and be technically & scientifically multi-lingual with expertise in biology, pharmacology, medicine, data science, bioinformatics, digital and/or technology in order to be successful. This role will work closely with the Astellas' discovery and early development research scientists, as well as with the bioinformaticians, data scientists, statisticians and broader core R&D teams responsible for deciphering the molecular & pathway underpinnings of disease in order identify targets, leveraging various drug modalities to design new molecular entities, identify rational therapeutic combinations, prioritize indications and subsegments of patient populations for treatment, and inform the design and conducting of clinical trials to increase success of the early POC studies.

Primary Responsibilities:

• Leverage computational biology, machine learning, and bioinformatics skillsets to support drug discovery and early development through data-driven approaches

• Prototype the development and application of state-of-the-art tools or data-mining techniques for integrative analysis and visualization of multi-dimensional datasets for target identification, biomarker discovery, indication selection, target validation, patient segmentation, and understanding the mechanisms of disease.

• Integrate genomic and experimental data using established and/or in-house platforms to help refine patient population and responder hypotheses.

• Prototype tools and analysis strategies to generate focused hypotheses across the drug discovery and early development portfolio

• Collaborate on a variety of computational biology and genomics projects focused on the needs of discovery and early development functions

• Work synergistically with the fellow leaders to manage the portfolio and set project priorities

• Assist in the identification and evaluation of potential data sources

• Assist in the onboarding and structuring of datasets into Astellas' data and analysis environment(s)

• Establish effective communications with all internal stakeholders to understand underlying business and scientific chalenges

• Serve as a player-coach to lead analytical talent to work with the cross-functional project teams to scope out analyses to address key questions

• Ensure that analyses are analytically valid and appropriately planned and executed;

• Manage collaborations and lead analyses across multiple internal & external databases and experts to ensure that Astellas sponsored TS-DSA initiatives are successfully enabling the translation of discovery research into the clinic, and ultimiately supporting the needs of patients, health care providers and payers.

• Innovate and deliver prototypes of new analytical methods, dashboards, and software tools that enable efficiencies (e.g., exploratory self-service, more rapid question-to-insights journeys) that influence peers and other teams within Astellas to productize

Essential Job Responsibilities:

• Support the Head of Translational Sciences Data Strategy & Alliances by providing computational biology, data sciences (machine learning, deep learning, AI), bioinformatics and statistical expertise for all TS-DSA projects as requested

• Contribute to TS-DSA projects/initiatives, methods development, documentation, scientific publications, and independent research proposals across multiple teams in all therapeutic areas for both in-line and development projects across multiple functions

• Conduct exploratory data analyses of new data sources to assess completeness and fit for purpose; incorporate into disease specific data tables to support integrated analyses.

• Innovate and delivery prototypes that embed data and analytics into digital solutions that enable efficiencies throughout the organization, and help transition these prototypes into productization by collaborating with digital solutions teams within AIA and broader Astellas

• Implement analyses and studies, defining endpoints, executing protocols with data programming, conducting statistical analyses using R, SQL, Python, Perl, SAS and other programs

• Participate in Machine Learning & Artificial Intelligence innovation at Astellas in the context of applications of various data sources towards impacting drug discovery and development, with an emphasis onbuilding capabilities and informing software development

• Ensure that all analyses are performed in accordance with good coding and statistical practice and any applicable regulatory guidelines

• Provide data, digital, and analytical support to discovery and early development projects to inform the data, digital, analytical roadmap for R&D

• Assist the Head of TS-DSA to grow the portfolio of incoming projects by building strategic scientifically- and technically-aligned collaborations with Astellas colleagues, particularly USA-based research affiliates and early development functions, and external partners to advance TS-DSA initiatives as appropriate

• Assist as a Subject Matter Expert in managing vendor relationships and influencing decision making in regards to those relationships

• Mentor new employees and interns towards making impact and ensuring team & divisional annual objectives are on-track and/or accelerated

• Assist in managing relevant contract and/or professional services resources to ensure project execution to stakeholder satisfaction

Quantitative Dimensions:

The Associate Director, Computational Biology & ML/AI supports the use of data, digital, and advanced analytical techniques to address key discovery and development questions across the life cycle of drug development. Their work focuses on target & disease identification, data-driven prioritization based on quantification, mechanistic insights, patient characterization, identification of key patient segments within a disease area based on symptoms, comorbidities and underlying molecular patterns, etc.). The role is an integral part of the organization leading from a scientific- and computational-point of view, identifying key data, digital, and analytics needs, developing plans to prioritize and address those needs, collaborating with AIA colleagues and other functions to implement the roadmap, and conducting requisite analyses to address business and scientific needs. They are responsible for innovating and prototyping digital and analytical tools that enable efficiencies throughout Astellas' portfolio of projects. They are responsible for collaborating with internal across multiple products and therapeutic areas to provide technical and scientific expertise, assessment and management for TS-DSA projects. The results produced by the Associate Director must be reproducible and statistically sound, and are subject to internal and external inspections.

Organizational Context:

• Associate Director, Computational Biology & ML/AI reports directly to the TS-DSA Head initially as an individual contributor. Once the role is established, the objective is to eventually build a small team to support strategic plans and shared objectives that impact discovery to early stage drug development across Astellas' primary focus areas. They will collaborate closely with multiple project teams across Astellas functions, geographies and therapeutic areas. The role will collaborate with the colleagues across the Astellas value chain, with an emphasis on discovery and early development functions:

• Various Research Hubs reporting into Astellas' Chief Scientific Officer

• Strategic functions: Primary Focus Leaders and their staff reporting into Astellas' Chief Strategy Officer

• Various Translational Sciences functions within Astellas' Discovery Hubs and Early Development functions

• External: Astellas partners, Vendors, Key Opinion Leaders.

• Collaborates directly with QA operational members, QA staff, and various levels across

• Astellas functions.

• Functions as the QA main point of contact for assigned teams and functional areas.

Qualifications:

Required:

• A PhD degree in computational biology, bioinformatics, biomedical engineering, pharmaceutical sciences, quantitative biology, computer science, or related, with 5+ years of hands-on experience in the field post-PhD and at least 3 years in direct support of biopharmaceutical R&D activities

• Strong experience in machine learning, deep learning, artificial intelligence, natural language processing, computational biology, bioinformatics, or related with proven track record (e.g., publications, conference presence, patents, awards, etc.)

• Expertise in one or more therapeutic areas including oncology, immuno-oncology, auto-immune diseases, respiratory, endocrine, or rare diseases

• Consistent track record of developing and executing data science research projects, particularly experience working with various types of pre-clinical data and patient-level RWD data sources including large clinical registries, insurance claims, electronic medical records, laboratory results, genetic markers, gene expression data, mutation data, and potential digital assets that may be derived from biobank specimens

• Experience with R, Python, TensorFlow, and other data science, data analysis, and visualization software such asScikit-Learn, Knime, Pytorch, Tableau, Qlik,etc.

• Advanced Bioinformatics experiences working with data from major -omics sources, i.e. NCBI, EGA, or dbGap

• Experience in working with clinical coding systems such as MEDRA, SNOMED, RxNorm, ICD9/10, LOINC, OMOP, CDISC, MESH, etc

• Experience working with a variety of patient data modalities (e.g., IHC, radiology, single cell genomics, proteomics, digital pathology, patient reported, wearable)

• Experience in working on project teams and managing projects and people within a highly matrixed environment

• Advanced and broad knowledge of analytical methodologies and strong understanding of industry practices related to the analysis, modeling, and use of real world data, public domain data and pre-clinical data.

• Excellent organizational, people, project and time management skills

• Solid oral, written, and presentation communication skills (e.g. able to clearly communicate statistical and epidemiological issues and methods to statisticians and non-statisticians)

Preferred:

• Experience in the development & execution of RWD (observational) studies and/or peer reviewed manuscripts

• Experience serving as a software product manager that influences software development teams' roadmaps, particularly data platforms and infrastructure to support data analyses

• Software Development skills to enable transition of prototype code into production-ready code

• Demonstrated Business Development and Partnership Development skills

• Experience working on cloud-based computing enviornments (AWS, Azure, Google Cloud) using multiple OS (e.g., Linux, Windows).

• Experience working with vendor or open source data platforms (e.g., GeneData, cBioPortal, Terra)

• Experience representing their organization in Industry-Academic collaborations and consortia

• Experience with Open Data and Analysis projects such as OHDSI, GA4GH, etc.

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 Advanced Informatics & Analytics

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