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  • Data Management Lead  

    Astellas Pharma Inc.
    - united kingdom
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    Description Data Management Lead About Astellas: At Astellas we are a... Read More
    Description Data Management Lead About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their caregivers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. The Opportunity: As a Data Management Lead, you will be responsible for study level data management activities within a drug development program. This includes all aspects of study level DM deliverables (data standards, eSource, Medical Coding, database build, external data, central monitoring, etc.), and overall management/oversight of all data management activities for assigned projects. The individual ensures that studies within the program are executed within the agreed timelines and according to the agreed global standards and processes. You will have to take full accountability for the DM deliverables across multiple studies and is responsible for all vendor oversight for any outsourced DM activities. The position contributes expert level Data Management knowledge and consultation to the clinical program team, as well as to other stakeholders within Development. This role may act as a key contact and lead of DM process and technical/systems improvement initiatives. Hybrid Working: At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver. Key Activities for this role: Very strong subject matter expertise in the Data Management (DM) discipline. Can support multiple studies concurrently with little to no oversight by functional manager. May act as a functional DM expert for a specific DM specialty area, such as data standards, Medical Coding, eSource, external data, data visualization and analytics, etc. Review Key Risk Indicators (KRIs) outputs in aggregate across sites, regions and countries. As needed, review study level operational and patient data to support the investigation and root cause analysis of observations. Performs vendor oversight activities across multiple studies. Reviews and gives input in vendor oversight processes. Proactively shares and provides suggestions on how to improve vendor oversight. Uses metrics and key performance indicators (KPIs) to monitor vendor performance. Documents any process related deviations and communicates to functional manager. Triggers discussion or takes immediate action if there are concerns with respect to quality of DM deliverables. Leads the data review meetings for all data sources with Medical, Clinical Operations, Biostatistics, and Programming to highlight and discuss deviations to the protocol and specific data values relevant for the analysis/determining subject populations. Strong understanding of regulatory requirements, such as GCP, and how they impact Data Management activities and outputs. Essential Knowledge & Experience: Substantial years of relevant experience in pharmaceutical, clinical research, or health services industry, including strong experience as a Data Manager with progressive leadership responsibility. Demonstrated expertise in Data Management from program inception through regulatory submission (regulatory submissions experience preferred). Recognized leadership and subject matter expertise in Data Management related global process improvement initiatives. Extensive experience with external data management and digital health solutions (e.g., eSource, eCOA, eConsent), including edata processes, central monitoring tools, and risk-based quality management (RBQM) principles. Advanced understanding of clinical data standards (e.g., CDISC) and ability to apply standards across studies and programs. Prior inspection and audit experience. Preferred Qualification: SCDM Certified Clinical Data Manager (CCDM) preferred. Experience with RAVE, eClinical Solutions elluminate and CluePoints is a plus.Educations/Qualifications: Bachelor’s degree in biological science, health-related or computer science field or equivalent experience. Additional information: The is a permanent full-time position. This position is based in the UK. This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help. #LI-London#LI-Hybrid#LI-CC1 Read Less
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  • Statistical Science Lead, Director  

    Astellas Pharma Inc.
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    Description Statistical Science Lead, Director About Astellas: At Aste... Read More
    Description Statistical Science Lead, Director About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. The Opportunity: Would you like to join an organisation at the forefront of healthcare innovation, transforming cutting-edge science into VALUE for patients? Bring your unique skills, experience, perspectives, and ideas to Astellas. As a Global Statistical Lead, (GSTATL) for Haematology Oncology you will be a compound level leader within the Quantitative Science & Evidence Generation (QSEG) organisation, accountable for driving the statistical and analytical strategy for a compound or indication across its full development lifecycle. You will lead a cross-functional, integrated quantitative team supporting evidence generation and decision-making, with responsibility spanning clinical trial statistics, exploratory statistics, medical affairs statistics, real-world evidence (RWE), safety/pharmacovigilance (PV) statistics, statistical programming, biomarker statistics, and advanced analytics. The role reports to the Head, Statistical Science, Oncology / Immuno-Oncology and is located in Bourne, UK. Hybrid Working:At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Key Responsibilities: Ensuring consistency and scientific excellence across studies, indications, and evidence type, while enabling innovation in statistical methodology, clinical development optimisation, and external engagement. The GSTATL plays a key role in regulatory and payer strategy, as well as internal governance and portfolio planning for haematology oncology assets. Providing strategic statistical Leadership - Serving as the compound-level statistical lead for haematology oncology, responsible for end-to-end quantitative strategy supporting clinical development, evidence generation, and regulatory/payer interactions. Leading the development of integrated statistical strategies across all relevant study types and functions (e.g., e.g., phase 1b/2 signal-seeking, pivotal, exploratory, RWE, post-marketing). Aligning statistical and analytical approaches with the target product profile (TPP), development strategy, and external evidence needs. Ensuring Cross-Functional Team Leadership: Leading a diverse team of statisticians and analysts across clinical, medical affairs, RWE, safety, and biomarker domains to ensure scientific integration and quality. Representing Astellas in global regulatory and payer interactions, guiding statistical content for submissions and evidence strategies. Leading on all statistical matters in global regulatory interactions (e.g., FDA, EMA, PMDA). Guiding preparation of statistical content for regulatory submissions, briefing packages, and health technology assessment (HTA) dossiers. Essential Knowledge & Experience: Demonstrable experience in oncology clinical development, with proven leadership in statistical strategy and regulatory submissions. Proven experience leading statistical contributions at the compound level, including regulatory engagement and cross-functional integration. Broad expertise across clinical trial design, exploratory oncology analytics, biomarker evaluation, RWE, and post-marketing study support. Worked across clinical trial statistics, exploratory statistics, Medical Affairs statistics, biomarker statistics, safety/PV statistics, real-world evidence (RWE) analytics, and statistical programming. Strong understanding of the drug development lifecycle, regulatory requirements, and evidence generation for both approval and market access. Preferred Experience & Qualifications:PhD (or MSc with equivalent experience) in Biostatistics or Statistics.Prior experience with oncology basket/umbrella trials, tumour-agnostic strategies, and adaptive development pathways. Familiarity with indirect comparisons, external controls, and payer analytics for oncology submissions. Familiarity with Bayesian methods, adaptive designs, external control arms, and AI/ML applications in clinical development. Experience working with real-world data sources, including data integration, study design, and interpretation. Scientific contributions through publications, presentations, or participation in industry/regulatory working groups. Contributions to ASCO, ESMO, or other oncology-related publications or working groups. Strong leadership presence and ability to represent the organization in regulatory, HTA, and scientific discussions externally. Education: Educated to M.S level or higher in Biostatistics, Statistics or equivalent.Additional information: This is a permanent full-time position. This position is based in the UK. This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-Addlestone#LI-Hybrid#LI-EN1
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  • Statistical Programming Lead  

    Astellas Pharma Inc.
    - united kingdom
    Apply Now
    Description Statistical Programming Specialist:  About Astellas: At As... Read More
    Description Statistical Programming Specialist: 
     About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. Opportunity: As a Statistical Programmer, you will take ownership of programming tasks and play a key role in delivering high-quality programming for clinical and Medical Affairs studies. You’ll work on complex and innovative projects within development programs, which include clinical/observational studies, PK/PD analysis, Biomarker research, and regional studies. You’ll be responsible for global deliverables at both the study and submission levels, within one or more Primary Focus (PF) areas. In this role, you'll also provide oversight of programming vendors for assigned compounds, ensuring deliverables meet the highest standards. You’ll have the chance to contribute to the improvement of departmental and functional infrastructure, helping us build stronger programming practices across the organisation. For complex tasks — spanning from individual late-phase clinical trials to global regulatory application submissions, HTA submissions, and post-marketing support — the role is focused on delivering excellence and innovation. Hybrid working: At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Responsibilities and Accountabilities: Producing high-quality, on-time statistical programming deliverables, including datasets and tables/listings/figures (TLFs), ensuring all outputs are fully compliant with Astellas, industry, and regulatory standards. Ensuring integrated programmed deliverables are submission-ready and meeting the expectations for global regulatory use. Overseeing the efficient use and management of programming vendors to maintain consistency, quality, and timeliness. Leading the internal programming team for insourced work, and collaborating with vendor leads for outsourced projects to ensure seamless communication and delivery. Providing regular oversight of statistical programming activities performed by Full-Service Providers (FSPs), and acting as the key liaison between Astellas and its external partners. Personal Development / Collaboration Recognising and addressing issues that could impact the validity, accuracy, or completeness of deliverables. Contributing to cross-functional and indication-level improvement initiatives, such as writing SOPs, implementing innovative statistical software, standardising outputs, and maintaining adherence to indication-specific programming standards. Collaborating with peers to devise creative and efficient solutions for common programming challenges. Supporting the recruiting, training, developing, and retaining of talented statistical programming professionals. Engaging with external professional and industry organisations, building networks, and sharing knowledge to stay at the forefront of best practices in statistical programming. Required Experience:Demonstrating solid experience in statistical programming within the pharmaceutical industry, including extensive collaboration with external vendors. Bringing proven expertise as a lead programmer overseeing programming activities across drug development programs. Possessing strong capability in mentoring, guiding, and developing statistical programmers to enhance team performance and technical excellence. Education: Bachelor’s or master’s in statistics, mathematics, or equivalent Working Environment:The is a permanent full-time position based in the UK. This position follows our hybrid working model. Role requires a blend of home and minimum of 1 day a quarter in our Addlestone office. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help. #LI-Addlestone#LI-Hybrid#LI-LG1 Read Less
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  • Development Physician/Medical Director, Oncology  

    Astellas Pharma Inc.
    Apply Now
    Description Development Physician/Medical Director, OncologyAbout Aste... Read More
    Description Development Physician/Medical Director, OncologyAbout Astellas: At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges putting the patient at the heart of every move we make. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked. We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners. The Opportunity: As the Development Physician (Medical Director), you will oversee the design and delivery of trials within a given late phase program or multiple early-phase programs in the Immuno-Oncology group. Working as part of a diverse, agile, and global development team you will be the clinical team leader responsible for knowledge management, partnership and collaboration as required in drug development. This role Reports to the Medical Lead for the given program(s) and is accountable for defining the strategy and execution of assigned trials and is located in Bourne, UK. Hybrid Working: At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Key Responsibilities: You will collaborate effectively with key internal and external stakeholders as a member of the asset team and leader of the clinical study team to advance one or more clinical trials. Serve as Medical Monitor with responsibility for safety monitoring whilst ensuring patient safety on clinical study is maintained. You will generate safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete. Partner closely with safety officer in writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events. Will co-ordinate with the Safety Officer on program for appropriate benefit-risk assessments, planning FIH study dose selection and escalation path for early-phase programs, safety management on trials, provides clinical input and review of clinical documents, statistical analysis plans, interim and final analyses on trials, publications, CSRs, DSURs and other critical documents. Be responsible for managing the process of development of protocol and necessary regulatory documents. Will assimilate Research, Clinical Pharmacology, Biomarker, medical safety, Toxicology (early phase programs) regulatory, biostatistics, medical affairs, Health Economics, commercial perspectives into clinical development strategies and trial designs. Essential Knowledge & Experience: Experienced in development and implementation, and execution of clinical trials as part of a large complex late phase (post POC, established market) program or a group of earlier stage programs, in alignment with Asset and overall clinical strategy. Managed clinical trial budget and timelines and for advice and decisions in scientific/clinical, technical areas that may impact development timelines including regulatory review periods, probability of success or budget extensions or overruns. Served as the clinical interface in regulatory authority interactions. Will be accountable and responsible for development and implementation, and execution of clinical trials as part of a large complex late phase (post POC, established market) program or a group of earlier stage programs, in alignment with Asset and overall clinical strategy. Designed scientifically rigorous, cost-effective, and patient-centric clinical trials in accordance with the Clinical development Plan. Held accountability for Clinical trial scope development and authoring of the protocol, IB, ICF as appropriate, in coordination with development scientists, clinical operations, medical writing and regulatory. Extensive experience working within the pharmaceutical industry specifically in clinical trial design and execution in a bio-pharmaceutical development organization or a balance of experience at an academic institution and a pharmaceutical company. Working in global teams and a global matrixed, remote working environment. Documented experience planning and managing clinical trials, serving as medical monitor, managing trial execution in coordination with clinical operations. Preferred Knowledge & Experience: Extensive experience in gastroesophageal or thoracic oncology or immuno-oncology in solid tumours. Prior clinical research experience in an academic setting. Experienced in all phases of Clinical Development and interfaces with Drug Discovery through Marketing. Education: MD or PhD or equivalent. Additional information: This is a permanent, full-time position. This position is based in the UK. This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help. #LI-Addlestone#LI-Hybrid#LI-LG1 Read Less
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  • Development Physician, IOD  

    Astellas Pharma Inc.
    Apply Now
    Description Development Physician / Medical Director - OncologyAbout A... Read More
    Description Development Physician / Medical Director - OncologyAbout Astellas: At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges putting the patient at the heart of every move we make. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked. We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners. The Opportunity: As the Development Physician (Medical Director) you will oversee the design and delivery of trials within a given late phase program or multiple early-phase programs in the Immuno-Oncology group. Working as part of a diverse, agile, and global development team you will be the clinical team leader responsible for knowledge management, partnership and collaboration as required in drug development. This role Reports to the Medical Lead for the given program(s) and is accountable for defining the strategy and execution of assigned trials and is located in Bourne, UK. Hybrid Working: At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver.Responsibilities: You will collaborate effectively with key internal and external stakeholders as a member of the asset team and leader of the clinical study team to advance one or more clinical trials. Serve as Medical Monitor with responsibility for safety monitoring whilst ensuring patient safety on clinical study is maintained. You will generate safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete. Partner closely with safety officer in writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events. Will co-ordinate with the Safety Officer on program for appropriate benefit-risk assessments, planning FIH study dose selection and escalation path for early-phase programs, safety management on trials, provides clinical input and review of clinical documents, statistical analysis plans, interim and final analyses on trials, publications, CSRs, DSURs and other critical documents. Be responsible for managing the process of development of protocol and necessary regulatory documents. Will assimilate Research, Clinical Pharmacology, Biomarker, medical safety, Toxicology (early phase programs) regulatory, biostatistics, medical affairs, Health Economics, commercial perspectives into clinical development strategies and trial designs. Essential Knowledge & Experience: Experienced in development and implementation, and execution of clinical trials as part of a large complex late phase (post POC, established market) program or a group of earlier stage programs, in alignment with Asset and overall clinical strategy. Managed clinical trial budget and timelines and for advice and decisions in scientific/clinical, technical areas that may impact development timelines including regulatory review periods, probability of success or budget extensions or overruns. Served as the clinical interface in regulatory authority interactions. Will be accountable and responsible for development and implementation, and execution of clinical trials as part of a large complex late phase (post POC, established market) program or a group of earlier stage programs, in alignment with Asset and overall clinical strategy. Designed scientifically rigorous, cost-effective, and patient-centric clinical trials in accordance with the Clinical development Plan. Held accountability for Clinical trial scope development and authoring of the protocol, IB, ICF as appropriate, in coordination with development scientists, clinical operations, medical writing and regulatory. Extensive experience working within the pharmaceutical industry specifically in clinical trial design and execution in a bio-pharmaceutical development organization or a balance of experience at an academic institution and a pharmaceutical company. Working in global teams and a global matrixed, remote working environment. Documented experience planning and managing clinical trials, serving as medical monitor, managing trial execution in coordination with clinical operations. Preferred Experience: Extensive experience in gastroesophageal or thoracic oncology or immuno-oncology in solid tumours. Prior clinical research experience in an academic setting Experienced in all phases of Clinical Development and interfaces with Drug Discovery through Marketing. Education: MD or PhD or equivalent. Additional Information: This is a permanent full-time position. This position is based in the UK. This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help. #LI-Addlestone
    #LI-Hybrid 
    #LI-JU1 Read Less
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  • Market Research Excellence Partner  

    Astellas Pharma Inc.
    Apply Now
    Description Market Research Excellence PartnerAbout Astellas: At Astel... Read More
    Description Market Research Excellence PartnerAbout Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. The Opportunity: We are seeking a Market Research Excellence Partner to join our Warsaw team and play a pivotal role in transforming how we execute and govern Primary Market Research (PMR) across the organization. This is a strategic, cross-functional role focused on operational excellence, compliance, and innovation in market research processes. If you’re passionate about streamlining complex systems, driving global collaboration, and ensuring high-impact insights, this is your opportunity to make a difference. Hybrid Working: At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver. Key Responsibilities: Develop and maintain standardized PMR processes for global, regional, and local projects. Ensure compliance with E&C, PV, Regulatory, and medical standards across all PMR activities. Lead governance development for the use of AI in market research, in collaboration with Legal and other global functions. Identify and implement opportunities to reduce operational burden and improve efficiency. Drive updates to PMR SOPs and ensure training materials are current and effective. Coordinate with global functions to maintain systems supporting reporting requirements. Represent SI&A during audits and inspections related to PMR processes and projects. Manage vendor relationships and maintain a list of preferred global partners. Monitor PMR KPIs and lead continuous improvement initiatives across geographies. Oversee common PMR projects (e.g., ATU, brand tracking) and ensure high-quality delivery. Essential Knowledge & Experience: Strong experience in pharma or healthcare in market research, competitive intelligence, or strategic consulting. Strong project management skills with the ability to juggle multiple complex initiatives. Deep understanding of global pharmaceutical operations and business strategy. Proven ability to collaborate across functions and cultures in a global matrix environment. Excellent communication and stakeholder engagement skills. Proficiency in collaboration tools (e.g., MS Teams, SharePoint). Preferred Knowledge & Experience: University degree. Academic background in mathematics or science. Market Research certifications (e.g., IIPMR). Additional Information: This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.Astellas’ Global Capability Centres – Overview Astellas’ Global Capability Centre’s (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico. The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands. Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help. #LI-Hybrid#LI-Warsaw#LI-JU1 Read Less
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  • Lead, Global Market Access & Pricing, Women's Health (Senior Director)  

    Astellas Pharma Inc.
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    Description Lead, Global Market Access & Pricing, Women's Health (Seni... Read More
    Description Lead, Global Market Access & Pricing, Women's Health (Senior Director)About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. The Opportunity: As the Lead, Global Market Access and Pricing – Women’s Health (Senior Director), you will be responsible for the world-wide market access and pricing strategy for the product. You will develop and drive execution of the Global Market Access and Pricing Brand Strategy through leading a multi-disciplinary Value Access Strategy Team in co-creation of a best-in-industry value position strategy which optimizes product payer leverage points through tailored and where needed innovative payer solutions. The role will report into the Head of Global Market Access Strategic Brands and will work closely with other key cross functional partners across the region. Hybrid Working: At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver. Key Responsibilities: Represent Global Market Access &VAST perspective on payer needs as a core member of the Asset Maximization Team and Global Co-creation Team and impact Commercialisation and evidence generation strategy in alignment with AMT co-leads to optimise brand value under consideration of reimbursement & pricing requirements and dynamics.Lead the development and implementation of innovative pricing and reimbursement strategies using value-based methodologies that both capture optimal product value and support commercial strategy/product positioning for new indications.Develop global value story and global value dossier based on insights collated, identify areas needing Medical Affairs, Value Evidence, Clinical Development and Statistics input and seek analyses and evidence generation accordingly.Define the payer value requirements for the evidence generation plan throughout the lifecycle of the product, identify areas needing MA & VE input and execution in evidence generation plans and establish alignment with critical functions such as Regulatory, Clinical Development, Stats team and the co-creation and sub co-creation Markets and endorsement by senior leadership. Work collaboratively with MA/VE and Commercial and Development Leads at Global, Area and Affiliate level to deliver integrated Evidence Generation Plan (iEGP), Brand Market Access Strategic Plan, ensuring it is embedded within the integrated Global Brand Plan, Core Medical Plans and Global & regional development plans, and that customer-relevant Global Brand Value Plans are developed and delivered. Lead the Value Access Strategy Team (VAST) and represent GMAx and VAST on the Asset Maximization Team (AMT) and Global Co-creation team (GCT). Essential Knowledge & Experience: Proven experience in a regional / global market access position within a global pharmaceutical organization. Experience across Market Access, Reimbursement or HEOR experience in the pharmaceutical industry with a proven track record of strategy development and execution. Strong understanding and experience of working within different payer environments and drivers for reimbursement, value-based access, and how to integrate into drug development and commercial strategies. Deep knowledge / scientific background on the assigned therapy area – women’s health will be highly preferred. Leadership skills and demonstrated ability to work effectively / influence without authority throughout the organization and on a global basis. Strong written and verbal communication in English. Preferred Experience: Strong interpersonal, communication & collaboration skills working cross-functionally within matrix structures. Education: Post-graduate qualification such as MBA and/or MSc or equivalent. Additional information: This is a full time, permanent position. The role is based out of Addlestone, UK or could be based in the Nordic countries or the NetherlandsThis position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our Addlestone office. Flexibility may be required in line with business needs. What We Offer:A challenging and diversified job in an international setting.Opportunity and support for continuous development.Inspiring work climate. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-Addlestone#LI-Hybrid Read Less
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  • Site Contract Manager  

    Astellas Pharma Inc.
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    Description Site Contracts ManagerAbout Astellas: At Astellas we are a... Read More
    Description Site Contracts ManagerAbout Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. The Opportunity: As a Site Contracts Manager, you will oversee the review and execution of global site contracts for Astellas clinical studies, including both individual and master-level Clinical Trial Agreements, across insourced and outsourced models. You will support Clinical Operations (and occasionally Medical Affairs), ensuring contracts comply with regulatory, legal, and data privacy standards. You will play a key role in maintaining global best practices and ensuring contracts are delivered in line with project timelines and compliance requirements.This role reports into the Site Contract & Budget Lead. It involves close collaboration with internal teams such as Legal, Data Privacy, and Ethics & Compliance, as well as external stakeholders like investigator sites and CROs. This position is based in the United Kingdom. Hybrid Working: At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office. Key Responsibilities: Working with the site contract team to proactively identify, risk-manage, including escalation and resolve issues that arise with clinical site contracts. Driving and/or contributing to the development and/or continuous update(s) to functional SOPs, Astellas Global Contract Negotiations Playbook and other relevant core processes and tools. Serving as the liaison to collaborate between site contract negotiators and designated legal partners (as needed) to support development or update to global templates and processes to help ensure timely, proactive, strategic, best-in-class legal advice and support, taking into account objectives of the organization, and the unique and varying global, regional and local legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk to the business. Providing draft of guidance documentation(s) and training, as required. Managing the changes of the documents, templates or training under their purview. Participating in strategic improvement/innovation projects as requested. Ensuring Industry Best Practice investigation and implementation. Essential Knowledge & Experience: Extensive global biotech/pharma experience in legal, site contracts/budgets and/or related functional area. Good understanding of the regulatory, legal and data privacy issues affecting the pharmaceutical industry, including GDPR as it relates to the core and country templates. Strong ability to grasp regulatory and legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment and provide practical and constructive legal advice. Proven success in execution of strategies for relevant non-project support functions. Strong knowledge of clinical development processes and ICH/GCP guidelines and regulatory requirements. Solid negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner. Education: BA/BS degree life science or equivalent. Preferred Experience: Prior paralegal or legal experience.Direct people management experience preferred.Additional Information: This is a permanent full-time position. Minimal (5-10%) travel required. This position is based in Addlestone, United Kingdom This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-Addlestone#LI-Hybrid#LI-ND1 Read Less
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  • Lead, Global Market Access & Pricing (Senior Director)  

    Astellas Pharma Inc.
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    Description Lead, Global Market Access & Pricing (Senior Director)Abou... Read More
    Description Lead, Global Market Access & Pricing (Senior Director)About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. The Opportunity: As the Lead, Global Market Access and Pricing, Oncology (Senior Director) you will be responsible for the world-wide market access and pricing strategy for the product. You will develop and drive execution of the Global Market Access and Pricing Brand Strategy through leading a multi-disciplinary Value Access Strategy Team in co-creation of a best-in-industry value position strategy which optimizes product payer leverage points through tailored and where needed innovative payer solutions. This is a Senior Director level and will report into the Head of Global Market Access Strategic Brands and will work closely with other key cross functional partners across the region. Key Activities: Represent Global Market Access &VAST perspective on payer needs as a core member of the Asset Maximization Team and Global Co-creation Team and impact Commercialisation and evidence generation strategy in alignment with AMT co-leads to optimise brand value under consideration of reimbursement & pricing requirements and dynamics.Lead the development and implementation of innovative pricing and reimbursement strategies using value-based methodologies that both capture optimal product value and support commercial strategy/product positioning for new indications.Develop global value story and global value dossier based on insights collated, identify areas needing Medical Affairs, Value Evidence, Clinical Development and Statistics input and seek analyses and evidence generation accordingly.Define the payer value requirements for the evidence generation plan throughout the lifecycle of the product, identify areas needing MA & VE input and execution in evidence generation plans and establish alignment with critical functions such as Regulatory, Clinical Development, Stats team and the co-creation and sub co-creation Markets and endorsement by senior leadership.Work collaboratively with MA/VE and Commercial and Development Leads at Global, Area and Affiliate level to deliver integrated Evidence Generation Plan (iEGP), Brand Market Access Strategic Plan, ensuring it is embedded within the integrated Global Brand Plan, Core Medical Plans and Global & regional development plans, and that customer-relevant Global Brand Value Plans are developed and delivered.Lead the Value Access Strategy Team (VAST) and represent GMAx and VAST on the Asset Maximization Team (AMT) and Global Co-creation team (GCT).Essential Knowledge & Experience: Proven experience in a regional / global market access position within a global pharmaceutical organization. Experience across Market Access, Reimbursement or HEOR experience in the pharmaceutical industry with a proven track record of strategy development and execution. Deep knowledge / scientific background on the assigned therapy area – oncology. Experience in Health Outcomes, Access and pricing, marketing, finance.Leadership skills and demonstrated ability to work effectively / influence without authority throughout the organization and on a global basis. Strong written and verbal communication in English.Preferred Experience: Strong interpersonal, communication & collaboration skills working cross-functionally within matrix structures.Education: Post-graduate qualification such as MBA and/or MSc or equivalent.Additional information: This is a full time, permanent position. The role is based out of Addlestone, UK or could be based in the Nordic countries or the NetherlandsThis position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our Addlestone office. Flexibility may be required in line with business needs. What We Offer:A challenging and diversified job in an international setting. Opportunity and support for continuous development. Inspiring work climate. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-Addlestone#LI-Hybrid Read Less
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  • Study Start-Up / Site Activation Manager  

    Astellas Pharma Inc.
    Apply Now
    Description Study Start-Up / Site Activation Manager About Astellas: A... Read More
    Description Study Start-Up / Site Activation Manager About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. The Opportunity: As a Study Start-Up / Site Activation Manager you will be responsible for the Study Start Up (SSU) activities and strategy including the use of various clinical systems (e.g. CTMS) to enable consistent and compliant forecasting and data collection. You will represent Clinical Operations both early and late on cross-functional initiatives and systems implementation teams to articulate clinical trial business process requirements used across various therapeutic areas, trial designs, and global requirements to support development of robust functional requirements for new or enhanced applications and reports. This role will work within Clinical Operations both early and late and with partnering functions (e.g., IT, IS) to define standard operational terminology and data conventions used for clinical systems. This role will work with business process and system owners to define user roles, permissions, and training requirements. This position sits within Clinical Operations Excellence (COE) and is based in UK. Hybrid Working: At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Key Responsibilities:  Supporting the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives.  Identifying and escalating issues that arise related to support SSU deliverables and effectively executing against assigned activities within SSU.  Ensuring oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other site activation requirements.  Generating and providing accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools.Leading the preparation of study level essential document templates, aiding in the preparation of content for Regulatory submissions. Handling ICF negotiations and facilitating any required escalations and involved in the preparation and submission of IMP Release Packages.Essential Knowledge & Experience:  Must have knowledge of clinical trial conduct, including, multi-centre, global trials with good knowledge of global site activation requirements.  Strong knowledge of drug development and ICH/GCP guidelines.  Good understanding of local SSU processes and requirements.  Proven project management skills and leadership ability  Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability. Education:  BA/BS degree life science or equivalent. Preferred Experience:  Global Experience with site activation activities including submission requirements.  Worked cross-functionally and with external providers  Experienced with development and implementation of process improvement related initiatives Additional Information:  This is a permanent full-time position.  This position is based in the UK.  This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #LI-Addlestone #LI-Hybrid #LI-EN1 Read Less
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