Astellas Pharma

Role Description Responsible for overseeing the design and delivery of trials within a given late phase program or multiple early-phase programs in the Immuno-Oncology group. - Reports to the Medical Lead/disease area strategy head for the given program(s) and is accountable for defining the strategy and execution of assigned trials. - Clinical team leader with clear understanding of areas of responsibilities and accountabilities of the role. - Team player who is comfortable in situations where the role serves as a consultant and support to other functions and particularly the asset area. - Understands the criticality of information and knowledge management, partnership and collaboration required in drug development. Role and Responsibilities: - Collaborates 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. - Serves as Medical Monitor with responsibility for safety monitoring. Ensures patient safety on clinical study is maintained. - Generates safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete. - Collaborates closely with safety officer in writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events. - Coordinates with Safety Officer on program for appropriate benefit-risk assessments, planning FIH study dose selection and escalation path for early-phase programs. - Provides clinical input and review of clinical documents, statistical analysis plans, interim and final analyses on trials, publications, CSRs, DSURs and other critical documents. - Able to 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. - Responsible for managing the process of development of protocol and necessary regulatory documents. - 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. - In late phase program serves as the Lead for an indication specific clinical development team and is responsible and accountable for both strategy and execution of the clinical development plan for that indication or line of therapy. - In earlier phases, serves as the clinical lead for the entire clinical development strategy and execution for a given program. - Acquires public knowledge regarding therapeutic landscape, potential competitor products and serves as clinical voice regarding the potential for impact on planned clinical, medical affairs and commercial strategies. - Creates and maintains scientific/clinical networks and seeks external opinion leader as appropriate. - Serves as the clinical interface during clinical advisory boards, investigator meetings, and interactions with opinion leaders. - Serves as the clinical interface in regulatory authority interactions. - Accountable for clinical development milestones for their given trials. - Supports Medical lead and Asset team at governance meetings and is able to present the clinical development plan in a succinct and clear manner at such meetings. - Works with Development Scientists and Clinical Operation Leads to ensure efficient and streamlined execution of clinical trials and acquisition and interpretation of high-quality clinical data to inform program-level decision making and overall development strategies. - Designs scientifically rigorous, cost-effective, and patient-centric clinical trials in accordance with the Clinical development Plan. - Accountable 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. - Responsible for keeping medical lead, asset lead and Development Head informed on progress of trials, risks, planned/required mitigations, and changes to timelines and budgets. - Supports clinical development related initiatives as needed. - Leads and/or participates in scientific and medical training to other team members and external clients, investigators, and other site staff as it pertains to assigned studies. Qualifications - MD or MD/PhD with oncology fellowship complete. Board certified with patient treatment experience beyond fellowship preferred. - Must have 5 years of pharmaceutical industry or academia experience 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. - Proven record of designing clinical trials that can produce high quality data in a timely manner for decision making. - Documented experience planning and managing clinical trials, serving as medical monitor, managing trial execution in coordination with clinical operations. - Excellent verbal and written communication skills in English. - Experience working in global teams and a global matrixed, remote working environment. - Aware of cultural diversity and how to influence and manage in a multi-cultural organization. - Highest level of scientific integrity and impeccable work ethics. Requirements - Extensive experience in gastroesophageal or thoracic oncology or immuno-oncology in solid tumors. - Prior clinical research experience in an academic setting. - Experience in all phases of Clinical Development and interfaces with Drug Discovery through Marketing. - Direct experience leading global regulatory marketing authorization submissions and defense of those submissions. 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. - Company fleet vehicle for eligible positions. - Referral bonus program. Salary Range $207,192 – $295,988 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

Role Description As a senior statistician, data scientist or clinical programmer, the position has a dual purpose: manage 4+ direct reports and have a major influence on the leadership and technical capabilities of the department. - The position can act as Global Statistical lead (GSTATL), Global Programmer Lead (GPROGL), Real World Data Scientist lead (RWDSL), Lead Product Statistician (LPS), Statistical Biomarker Lead (SBL) or as a Regional/site Head. - Expected to ask critical scientific questions, challenge hypotheses, designs and results interpretation. - Responsible for the optimal development and assignments of reports to Astellas asset teams, study teams or deliverables teams. - Supports Senior management with decision making at the asset and portfolio level. - Works independently and engages the right level of participants as needed. - Represents Astellas on statistical matters related to clinical data, RWD, Biomarkers PROs, PK/PD analysis or methodology. Role and Responsibilities - Accountable for multiple projects, challenging and assessing the asset strategy. - Ensures the statistical/scientific soundness of all input and deliverables for the assigned projects. - Advises asset teams on challenging statistical/epidemiological design, analysis and decision-making issues. - Explains how RWD and Clinical Trial post hoc analyses can support drug development. - Describes how omics and biomarkers can support drug development and the BOLD objectives. - Oversees programming support for all stakeholders’ needs globally. - Performs/supervises modeling and simulations. - Provides oversight on statistical/scientific/programming matters for meetings with regulatory authorities. - Reviews key project level documents. - Participates in due diligence activities, external initiatives or working groups. - Presents and defends complex solutions to governance committees and key stakeholders. - Stays at the cutting edge of methodology development in statistics and industry trends. - Ensures efficient and innovative ways of programming are selected for each deliverable. - Researches, creates, validates, implements and teaches complex methodologies. People Management - Supervision (first line manager) of 4+ direct reports. - Assist with recruitment, development / career management and retention of staff. - Oversees adherence to timelines, standards, processes for work assigned to their members of staff. - Responsible for compliance of direct reports with Astellas policies and procedures. Personal development / Collaboration - Challenges and influences peers and senior managers on best practice. - Develops and maintains relationships with peers and key leaders. - Participates in professional association activities to support the branding of Astellas. - Ensures programming team stays current with changes in regulatory requirements globally. - Contributes to recruitment, training, professional development and retention of statistical programming personnel. - Partners with SRS LT to set short- and long-term strategic direction for programming function. - Partners with programming team in other Astellas sites for global consistency. Qualifications - Bachelor’s or master’s in statistics, mathematics, or related field. - 12+ years (15+ years for Bachelor) of relevant programming experience in the pharmaceutical industry. - 8+ years’ experience as a lead programmer on global clinical studies. - 5+ years’ experience in mentoring/leading statistical programmers. - Prior working experience with Oncology. - Prior experience leading a team. Location and Working Environment This position is based in Northbrook, Illinois. Remote work from anywhere in the US is available. Benefits - Medical, Dental and Vision Insurance. - Generous Paid Time Off options, including Vacation and Sick time, plus national holidays. - 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. - Company fleet vehicle for eligible positions. - Referral bonus program. Salary Range $170,450 - $243,500 (Final compensation will be determined based on a variety of factors.)

Role Description The primary purpose of the Development Scientist will be to participate in the development of clinical strategies for assigned modalities or indications within the division. This position will work closely with the Global Medical Lead (GML), Operations Lead, and Development Physician, and is accountable for the design, implementation, monitoring, and analysis of clinical studies conducted within the assigned program. Development Scientists are expected to perform their responsibilities independently and have core knowledge of clinical development to enable increased participation in division and portfolio level initiatives. Role and Responsibilities: - Responsible and accountable for activities related to all current and planned clinical trials (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting) on assigned development programs. - Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussion and timely decision making. - Serves on the clinical sub-team with GML, Operations Lead, and Medical Monitor/Study Physician and supports preparation of clinical development plans, site identification and management, and DESC meetings. - Under the guidance of development physician/GML, performs medical monitoring activities (Review, analyze and triage patient data, generating reports). - Able to independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan. - Partners with GML in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries. - Together with the GML and Product Responsible Person may prepare analysis for DMC/DSMB/DEC forums or regulatory submissions. - Provides training at investigator meetings and site initiation visits with clinical trial staff, and partners with Clinical Operations and Medical Affairs in enabling appropriate enrollment into the clinical studies or registries. - Collaborates cross-functionally to create, review, and/or present clinical slides for internal meetings and external forums. - Supports engagement with potential and current sites (e.g. SIVs, investigator meetings, conferences, steering committee, advisory board meetings). - Exhibits expertise related to Study Data Review and Analysis: - Provides clinical input into statistical planning, data analysis and interpretation. - Provides clinical leadership and support for publication of data (manuscripts, presentations) and disease or technology related scientific publications. - Works closely with operations group for site and vendor feasibility, trial set up and monitoring. - May lead the execution of contracts, particularly for investigator meetings and advisories. - Supports efforts to develop strategic partnerships with Key External Experts (KEEs). - Serve as key partner for Development Division in assessment of candidates within discovery, identifying opportunities and potential risks with future development strategies based on modality, indication, unmet need, competitive landscape and clinical characteristics. - May represent development and assist with clinical assessment for due diligence(s) of new assets for potential in-licensing and acquisition. - Supports strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested. - Performs other duties as assigned or special projects as needed. Qualifications - Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 5-7 years clinical, scientific/research, pathology or industry related experience or combination of academia and industry. - Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early-stage development through approval) from initial study design, study execution and regulatory submissions (INDs, BLAs, NDAs) with US and OUS regulatory agencies. - Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and/or relevant accreditations). - Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Teams and MS Project) and in the use of industry-standard software (e.g. electronic data capture systems [RAVE, InForm, etc.]) and proficient in data analysis software (Excel, SigmaPlot, SPSS, R, etc.). - Strong collaboration and interpersonal communication skills; able to interact with all levels of internal stakeholders and key functional areas including, Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science and Pharmacovigilance (PV). - Demonstrated success working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities. - Knowledge of global pharmacovigilance standards and guidance documents. - Comfortable working in a flexible, dynamically changing and (at times) challenging environment. - Excellent strategic planning, organizational and verbal and written communication skills. - Ability to exercise sound judgment, tact, diplomacy and professionalism in all interactions. - Aware of cultural diversity and how to influence and manage in a multi-cultural organization. - Highest level of scientific integrity and impeccable work ethics. Requirements - M.D. or PharmD degree, or other relevant Master’s degree. - Knowledge and proficiency related to Medical Affairs activities including registries. 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. - Company fleet vehicle for eligible positions. - Referral bonus program.

Role Description The Modality Intelligence Lead is a scientific subject matter expert within the Oncology Research Intelligence group, specializing in the strategic analysis of emerging therapeutic modalities such as next gen ADCs, engineered biologics, or small molecules. Reporting to the Head of CI&RPM, this role provides deep, cross-oncology research portfolio insights on modality trends, competitor activities, platform technologies, and translational relevance to inform Oncology Research strategy. - Continuously monitor scientific, clinical, and technological advances across prioritized therapeutic modalities. - Identify emerging trends, breakthroughs, and risks with implications for Astellas' oncology research strategy and modality capabilities. - Develop structured landscape assessments and foresight reports highlighting implications for internal pipeline differentiation and innovation gaps. - Collaborate with External Innovation Partners and Business Development to assess novel platforms, technologies, and innovation opportunities aligned with prioritized therapeutic modalities and the overarching Oncology Research Strategy. - Support nonclinical-stage opportunity assessments by providing strategic modality insights, and lead the development of internal opportunity briefs and evaluation proposals for potential collaborations, partnerships, or in-licensing opportunities. - Act as a trusted advisor to CI&RPM and other sub-function units in Oncology Research, and other scientific stakeholders on modality trends and strategic implications. - Partner with Innovation Intelligence analysts and Research Strategy Leads to ensure data-driven modality insights inform broader Oncology Research Strategy development. - Contribute to the enhancement of intelligence infrastructure (e.g., databases, dashboards, horizon scanning tools) with a modality focus. Qualifications - Advanced degree (PhD, MD, MBA, or equivalent) in life sciences, pharmacology, medicinal chemistry, bioengineering or related field. - Minimum 8 years of experience in pharmaceutical R&D, external innovation, academic collaboration, or scientific partnering. - Deep technical understanding of one or more modality platforms (e.g., engineered biologics, engineered small molecules, next generation ADCs). - Strong analytical skills with the ability to synthesize complex datasets and scientific trends into actionable strategy. - Proven experience influencing research or portfolio decisions through strategic insights. - Familiarity with the external innovation ecosystem including biotech start-ups, platform companies, and academic research. - Experience working closely with Research Leadership and Business Development on strategic evaluations. - High digital literacy and familiarity with CI or analytics tools/platforms. - Effective communication skills, with ability to convey scientific and strategic ideas to both technical and executive audiences. 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 - Company fleet vehicle for eligible positions - Referral bonus program

Role Description We are looking for a dynamic and experienced Lead, Information Security Architect to join our team. In this role, you will be responsible for designing and implementing advanced security technologies that safeguard our organization’s digital assets. You will collaborate with various teams to ensure that security is embedded in our technology solutions and infrastructure. - Design and implement Information Security architectures that align with business objectives and industry best practices. - Evaluate and recommend Information Security technologies, tools, and solutions to enhance the organization’s security posture. - Lead the development of Information Security policies, standards, and procedures related to technology architecture. - Collaborate with IT, development, and operations teams to integrate Information Security measures into existing and new systems. - Conduct threat modeling and risk assessments to identify vulnerabilities and recommend mitigation strategies. - Stay informed about emerging Information Security technologies and trends, and assess their applicability to the organization. - Provide technical leadership and mentorship to Infrastructure, Security and IT teams, fostering a culture of security awareness. - Communicate Information Security architecture concepts and strategies to stakeholders at all levels of the organization. Qualifications - 10+ years in infrastructure and cybersecurity, with at least 5+ years leading global teams in infrastructure or security operations, identity management or security engineering. - Proven experience in the pharmaceutical, healthcare, or other highly regulated industries preferred. - Strong understanding of infrastructure and security technologies, including firewalls, intrusion detection/prevention systems, endpoint protection, and encryption. - Experience with cloud security and securing cloud-based applications (e.g., AWS, Azure, Google Cloud). - Familiarity with security frameworks (e.g., NIST, ISO 27001) and compliance regulations (e.g., GDPR, HIPAA). - Excellent analytical and problem-solving skills, with a strategic mindset. - Strong communication and interpersonal skills, with the ability to work effectively in a team environment. - Bachelor's Degree Requirements - This position is based in Northbrook, Illinois. - Remote work from anywhere in the US is available. - Hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. 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 - Company fleet vehicle for eligible positions - Referral bonus program

Role Description This position is accountable for the direct management of assigned monitoring/site management related clinical trial staff across all clinical trial types, which may include pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional). - Accountable for the identification, onboarding, training and development of monitoring clinical trial talent. - Provides leadership/mentorship in a matrix setting for activities that support clinical trial teams. - Accountable to the Head, Early or Late Stage Site Monitoring & Management. - Provides input into departmental budget and resourcing strategies. - Develops and implements global processes and procedures. - Coaches monitoring staff during execution of development trials. Responsibilities - Responsible for resource planning, recruitment, mentoring, development and retention of site monitoring & management staff. - Manages and allocates monitoring resources to trials and monitors performance on assigned trials for monitoring staff (up to 12 direct reports). - Provides direction, leadership and learning opportunities to enhance individual development of direct reports. - Provides oversight and guidance in completing monitoring and site management related activities according to agreed timelines and quality standards. - Oversees adherence to timelines, standards, processes for work assigned to their staff. - Serves as a point of escalation for clinical monitoring/site management related topics or issues from their staff. - Oversees and provides guidance to Clinical Operations Leads and/or Clinical Trial Leads in regional Key Opinion Leader (KOL) interactions. - Responsible for compliance of direct reports with training and identification and support for any training needs. - Facilitates and supports global trial monitoring operational standards and tools. - Anticipates, recognizes and facilitates problem solving to support site monitoring & management staff. - Collaborates effectively with portfolio operations Leads, clinical operations leads, Center of Excellence and PECs leadership. - Identifies, escalates, and facilitates process improvements relevant to clinical trial monitoring and site management. - Contributes to development and implementation of best in class monitoring/site management standards and processes. Qualifications - BA/BS degree with at least 8 years of executing global drug development programs and trials. - Minimum of 4 years site monitoring and direct people management experience. - Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations. - Extensive expertise in risk based monitoring strategies and strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations. - Experience working across multiple phases of development and in multiple therapeutic areas. - Demonstrated ability to successfully identify and lead global process or system improvement initiatives. - Strong knowledge of clinical development processes and conducting global clinical programs. - Proven leadership skills and effective written and verbal communication skills. - Fluent in English. Depending on hiring region, may also be required to be fluent in local language. - Moderate (~30%) travel required. Preferred Qualifications - Advanced Degree. Location and Working Environment - Remote work from anywhere in the US is available. - Hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. 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. - Company fleet vehicle for eligible positions. - Referral bonus program. Salary Range $144,060 - 205,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

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: - Responsible for overseeing the design and delivery of trials within a given late phase program or multiple early-phase programs in the Immuno-Oncology group. - Reports to the Medical Lead/disease area strategy head for the given program(s) and is accountable for defining the strategy and execution of assigned trials. - Clinical team leader with clear understanding of areas of responsibilities and accountabilities of the role. Team player who is comfortable in situations where the role serves as a consultant and support to other functions and particularly the asset area. Understands the criticality of information and knowledge management, partnership and collaboration required in drug development. Essential Job Responsibilities: - Collaborates 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. Serves as Medical Monitor w/ responsibility for safety monitoring. - Ensures patient safety on clinical study is maintained. Generates safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete. - Collaborates closely with safety officer in writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events. - Coordinates with 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. - Able to 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. - Responsible for managing the process of development of protocol and necessary regulatory documents. - 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. - In late phase program serves as the Lead for an indication specific clinical development team and is responsible and accountable for both strategy and execution of the clinical development plan for that indication or line of therapy. - In earlier phases, serves as the clinical lead for the entire clinical development strategy and execution for a given program. - Acquires public knowledge regarding therapeutic landscape, potential competitor products and serves as clinical voice regarding the potential for impact on planned clinical, medical affairs and commercial strategies. - Creates and maintains scientific/clinical networks and seeks external opinion leader as appropriate. Serve as the clinical interface during clinical advisory boards, investigator meetings, and interactions with opinion leaders.  Serves as the clinical interface in regulatory authority interactions. - Accountable for clinical development milestones for their given trials. Supports Medical lead and Asset team at governance meetings and can present the clinical development plan in a succinct and clear manner at such meetings. - Works with Development Scientists and Clinical Operation Leads to ensure efficient and streamlined execution of clinical trials and acquisition and interpretation of high-quality clinical data to inform program-level decision making and overall development strategies. - Designs scientifically rigorous, cost-effective, and patient-centric clinical trials in accordance with the Clinical development Plan. Accountable 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. - Responsible for keeping medical lead, asset lead and Development Head informed on progress of trials, risks, planned/required mitigations, and changes to timelines and budgets. - Supports clinical development related initiatives as needed. Leads and/or participates in scientific and medical training to other team members and external clients, investigators, and other site staff as it pertains to assigned studies. Qualifications Qualifications: Required - MD or MD/PhD with oncology fellowship complete. Board certified with patient treatment experience beyond fellowship preferred. - Must have 5 years of pharmaceutical industry or academia experience 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. - Proven record of designing clinical trials that can produce high quality data in a timely manner for decision making. - Documented experience planning and managing clinical trials, serving as medical monitor, managing trial execution in coordination with clinical operations. - Excellent verbal and written communication skills in English. - Experience working in global teams and a global matrixed, remote working environment. - Aware of cultural diversity and how to influence and manage in a multi-cultural organization. - Highest level of scientific integrity and impeccable work ethics Preferred: - Extensive experience in gastroesophageal or thoracic oncology or immuno-oncology in solid tumors - Prior clinical research experience in an academic setting - Experience in all phases of Clinical Development and interfaces with Drug Discovery through Marketing. - Direct experience leading global regulatory marketing authorization submissions and defense of those submissions Salary Range $215,600– $308,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)   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  - Company fleet vehicle for eligible positions  - Referral bonus program

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The position is responsible and accountable for managing activities related to business and operations processes and systems utilized by the Functional Unit. This position may include oversight of the relationship with vendors within the Functional Unit, leading the creation of the annual plan and objectives in collaboration with senior leaders and responsible to oversee successful execution and delivery and/or ensuring Functional Unit is inspection ready at all times and that procedures, training and inspection readiness activities are being actively supported and managed across Functional Unit. - Contributes to the strategic direction of the clinical systems team including support of new technology deployment, enhancements and establishing data quality standards/oversight. - Ensures successful execution of training to functional team members on clinical systems and processes. - Identify new technology needs, support budget evaluation and business case development to launch technologies for the Functional Unit. - Work cross functionally to represent the technology needs for clinical trial operational execution. - Contributes to all eTMF processes including systems management, TMF migrations, document management processes, TMF compliance processes, archival processes and liaison with records and information management teams and regulatory authorities. - Supports all aspects of operational and process standards to ensure effective implementation, adaptation of process, oversight of process efficiency and identification of issues and risks. - Engages cross functional teams as needed to ensure efficiency and quality of vendor performance against Astellas expectations. Qualifications - Bachelor’s Degree required; MS degree preferred - Minimum 7 years of relevant work experience required - At least 5 years of pharmaceutical industry experience and good understanding of responsibilities and processes in one or more DS functional areas - Portfolio planning, forecasting, and budgeting skills and experience - Quality, compliance and/or inspection/audit experience - Familiarity with PM methodology preferred - Expert knowledge with clinical trial operational data and applications (i.e. Vault Clinical), including strategy - Prior experience with UAT testing, UAT test scripts, and preparing UAT data - Prior experience with enterprise system implementation or major enhancement build out - Prior experience as a business process owner or administrator of clinical operations systems - Prior experience with business requirements specification documents Requirements - Highly preferred to have experience with data governance – application or enterprise - Highly preferred on data flows from CRO data integrations – Milestones, reference data, or site data (organizations, locations, persons) - Highly preferred to have admin level support in operational applications - Highly preferred to have previous contributions to System Lifecycle Management process and documentation - Highly preferred to have experience with authoring job aids and business process documents - Highly preferred to have experience with measuring and managing data quality metrics and compliance - Preferred to have experience as a user or implementation of portfolio and project management systems - Preferred to have experience with development or specifications for dashboards, reports - Preferred to have experience as a user or implementation with site training solution - Preferred to have prior experience with a clinical trial execution role (clinical trial lead or manager, clinical research lead or manager) - Preferred to have prior experience implementing AI use cases for clinical trials 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 - Company fleet vehicle for eligible positions - Referral bonus program

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: The Global Category Lead – Contract Manufacturing is responsible for developing and executing the global category strategy for external pharmaceutical manufacturing partners. This role ensures that contract manufacturing capabilities are aligned with business priorities, pipeline needs, quality standards, and financial objectives. The scope includes strategic sourcing, supplier relationship management, and commercial governance across global Contract Manufacturing Organizations (CMOs/CDMOs), Expected to liaise with the Head of External Manufacturing, Quality, Supply Chain, Finance, and R&D. The role drives sustainable value creation while balancing cost, supply continuity, risk, and operational flexibility. Responsibilities and Accountabilities: Stakeholder Engagement: Serve as the primary commercial interface between Procurement and External Manufacturing, CDMO Quality, Supply Chain, R&D, and Finance. Supplier Relationship Management: Identify, evaluate, and manage strategic supplier relationships to deliver innovation, quality, and cost efficiencies while fostering collaboration and compliance. Drive joint productivity, innovation, and continuous improvement initiatives with key suppliers. Cost, Value, and Operations Optimization: Deliver sustainable, multi-year value creation beyond one-time price reduction. Target of 10% YoY. Develop and apply cost transparency and should-cost models to inform negotiations and decisions. Market Expertise: Maintain deep understanding of the global contract manufacturing market, including capacity trends, technology evolution, and cost drivers. Leverage market intelligence to inform sourcing strategies, negotiations, and risk mitigation plans Category Strategy Development and Enterprise Leadership: Develop and implement global category strategies for research and pre-clinical categories, ensuring alignment with business objectives and research timelines. People Leadership: Lead, coach, and develop category managers and sourcing professionals. Foster a culture of collaboration, accountability, and continuous improvement. Build functional capability in strategic sourcing, negotiation, and supplier management. Governance, Compliance and Reporting: Ensure adherence to corporate procurement policies, ethical standards, and regulatory requirements, maintaining full audit readiness. Provide category performance insights, savings tracking, and KPI reporting to senior management. Required Exceptional negotiation and contract management skills. Operational expertise (P2P, RFx, Negotiations, etc) Project Management acumen with the ability to drive change and develop operational models. Strong communication, relationship management, and influencing skills. Category credibility (scientific degree, category experience, etc) Cultural awareness and ability to work effectively in a global, matrixed environment. Preferred: Advanced degree (MBA, MSc, or equivalent) in life sciences or related field Understanding of the role of a global function within broader enterprise strategy Salary Range $170,450 - $243,500 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) 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 Company fleet vehicle for eligible positions Referral bonus program #LI-SS