Astellas Pharma

Role Description The Computer System Validation (CSV) Lead is responsible for developing, executing, and maintaining the validation strategy for GxP-regulated computerized systems supporting manufacturing, laboratory, and quality operations. This role ensures that all systems comply with applicable regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5, and that validation deliverables are developed in alignment with corporate and industry best practices. - Lead the planning and execution of validation projects for GxP computerized systems (manufacturing, laboratory, and quality). - Author and/or review CSV deliverables including Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications (FS), Design Qualification (DQ), IQ/OQ/PQ protocols, and summary reports. - Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable company SOPs and policies. - Collaborate with cross-functional teams (IT, QA, Manufacturing, Lab, and vendors) to define validation scope, strategy, and deliverables. - Lead impact assessments for software upgrades, patches, and configuration changes; ensure continuous validation state is maintained. - Support data integrity initiatives and periodic review programs. - Manage audit readiness for all validated systems; support internal and external inspections (FDA, EMA, MHRA, etc.). - Develop and maintain validation templates, SOPs, and training programs. Qualifications - Bachelor’s degree in computer science, Engineering, Life Sciences, or related discipline. - Minimum 5–8 years of experience in computer system validation or IT quality compliance within the pharmaceutical or biotech industry. - Deep understanding of GxP Principles, GAMP 5 lifecycle methodology, and 21 CFR Part 11 / Annex 11 compliance. - Experience leading validation of enterprise and laboratory systems such as LIMS, MES, QMS, ERP, or data historians (e.g., OSI PI, Empower, SAP, LabWare, etc.). - Strong technical writing and documentation skills with attention to detail. - Proven ability to manage multiple projects and priorities in a fast-paced, regulated environment. Requirements - Master’s Degree (MBA, MIS, or related field). - Experience with cloud-based or SaaS GxP systems. - Familiarity with data integrity, cybersecurity, and IT infrastructure qualification (IQ of servers, networks, virtualization). - Project management or Lean Six Sigma certification. 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 Global Statistical Lead (GSTATL) for Solid Tumor Oncology is a compound level leader within the Quantitative Science & Evidence Generation (QSEG) organization, accountable for driving the statistical and analytical strategy for a compound or indication across its full development lifecycle. This position leads 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 - Advanced analytics The role ensures consistency and scientific excellence across studies, indications, and evidence types—while enabling innovation in statistical methodology, clinical development optimization, and external engagement. The GSTATL plays a key role in regulatory and payer strategy, as well as internal governance and portfolio planning for solid tumor assets. Responsibilities and Accountabilities - Strategic Statistical Leadership: - Serve as the compound-level statistical lead for solid tumor oncology, responsible for end-to-end quantitative strategy supporting clinical development, evidence generation, and regulatory/payer interactions. - Lead development of integrated statistical strategies across all relevant study types and functions (e.g., phase 1b/2 signal-seeking, pivotal, exploratory, RWE, post-marketing). - Align statistical and analytical approaches with the target product profile (TPP), development strategy, and external evidence needs. - Cross-Functional Quantitative Team Leadership: - Lead and coordinate statistical and analytics contributions from a broad QSEG team, including: - Clinical trial biostatisticians - Exploratory oncology statisticians (e.g., tumor burden modeling, subgroup/signal detection) - Medical Affairs statisticians - Statistical programmers - Biomarker/statistical genetics experts in oncology - RWE analysts/statistical epidemiologists - Safety/PV statisticians - Advanced analytics and modeling specialists - Ensure scientific alignment, quality, and integration across all statistical contributions at the compound level. - Regulatory and HTA Engagement: - Represent Astellas on all statistical matters in global regulatory interactions (e.g., FDA, EMA, PMDA). - Guide preparation of statistical content for regulatory submissions, briefing packages, and health technology assessment (HTA) dossiers. - Lead the development of statistical components of payer evidence strategies, including indirect comparisons and external control methodologies. - Innovation and Methodological Excellence: - Champion the use of oncology-appropriate innovations, including Bayesian designs, adaptive trial designs, external controls, tumor-agnostic approaches, and AI/ML tools to enhance study design and signal detection. - Promote exploratory data analysis, modeling, and simulation to support rapid development decisions in Solid Tumor trials. - Integrate clinical, biomarker, safety, and real-world evidence to drive cohesive, data-driven development and access strategies. - Mentorship and Capability Development: - Mentor statisticians and analytics professionals across QSEG, supporting both scientific development and career growth. - Share knowledge and best practices across study teams and therapeutic areas. - Contribute to internal training, methodology development, and talent pipeline initiatives. - Governance and Cross-Functional Influence: - Participate in global asset governance and development team meetings, influencing decisions with rigorous statistical insight. - Collaborate with Clinical Development, Medical Affairs, Regulatory, Market Access, and Commercial to ensure alignment on evidence planning. - Lead or contribute to internal initiatives, including standardization efforts, methodology forums, and innovation networks. Qualifications - Advanced degree (PhD, MD, MBA, or equivalent) in Oncology, Life Sciences, or a related field. - Minimum 8 years of experience in pharmaceutical R&D, external innovation, academic collaboration, or scientific partnering. - Strong understanding of oncology drug discovery, translational science, and modality platforms (e.g., next gen ADCs, engineered biologics, engineered small molecules). - Proven ability to engage with scientific leaders and navigate early-stage biotech and academic ecosystems. - Excellent communication skills with the ability to synthesize complex scientific information into strategic insights. - Prior experience in academic liaison, external innovation, or strategic scouting in pharma/biotech or venture ecosystems. - Familiarity with CI platforms, digital literature monitoring tools, and academic/biotech databases. - A strong network in academia or biotech focused on oncology. - Experience in competitive intelligence, scientific scouting, or innovation strategy within oncology. - Familiarity with academic-industry collaboration models and consortia-based innovation. - High digital literacy and comfort with landscape analytics, scientific intelligence platforms, and conference tracking tools. Preferred Qualifications - PhD (or MSc with equivalent experience) in Biostatistics, Statistics, or a related quantitative discipline. - Minimum of 10 years of experience in oncology clinical development, with proven leadership in statistical strategy and regulatory submissions. - Demonstrated 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. - Broad expertise 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. - Ability to lead and influence cross-functional, global teams within a matrix environment. - Strong communication, collaboration, and stakeholder engagement skills across both technical and non-technical audiences. - Proficiency in statistical software (e.g., SAS, R) and familiarity with simulation tools and modern statistical methods. Location and Working Environment This position is based in Northbrook, IL. Remote work from anywhere in the US is available. At Astellas we recognize 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 optimize 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. 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 role serves as the primary point of contact for US brand business teams and the US Commercial and Medical Affairs Communications network for one or more priority brands. The role requires a strategic, insights-driven approach to external and internal brand communications, with a focus on fostering business growth, building stakeholder trust, and ensuring impactful, aligned execution across US market. Responsibilities and Accountabilities: - External Communications (75%) - Brand Communications - Working with brand leads, act as the point of contact for US brand business teams for assigned priority brand(s). - Foster business growth and stakeholder trust through a deep understanding and passion for the science, data and business priorities, leading co-creation of external brand communication campaigns. - Develop and deliver external communications campaigns for patients and/or HCPs to educate on brand value or disease awareness, aligned with business and medical strategy. - Identify and leverage robust insights to shape effective external brand communication campaigns and ensure high-quality execution through planning and content development. - Design and execute integrated omnichannel campaigns incorporating innovative engagement approaches, including partnerships with social media influencers (e.g., patients, physicians and other HCPs) to expand reach, credibility and impact. - Establish measurable outcomes for external communication campaigns in the US market, using findings to refine strategies and tactics. - Lead strategic communications for major US regulatory milestones, data milestones and US scientific congresses. - Develop and execute media engagement strategies, including development of core message frameworks. - Lead media training for US brand spokespeople. - Identify and execute strategic US media opportunities to position brands and senior commercial and medical affairs leaders as thought leaders. - Lead strategic projects to support additional business growth or enhance the capabilities of the US Brand communications team. - Issues Management - Proactively monitor and analyze US media to identify and manage brand-related issues that may impact stakeholder trust or Company reputation. - Provide strategic counsel to US brand business teams on brand-related issues. - Lead communications planning and execution for US brand-related issues, including Supply Chain disruption and crisis scenarios. - Internal Communications (25%) - Develop and execute internal communication strategies that inspire and engage brand teams to deliver on behalf of patients and the Company. - Establish metrics to measure the impact and effectiveness of internal communications programs. - Cross-Functional Collaboration - Collaborate with Corporate, R&D Communications and IR to ensure alignment on brand-related communications and issues overall. - Informs and/or collaborates with Corporate, R&D Communications and IR as appropriate on brand-related communications and issues. Qualifications - Bachelor's or advanced degree in Communications, Public Relations, Life Sciences or a related field. - Minimum of 8 years' experience in regional and/or local communication roles within the pharmaceutical or biopharma sector. - Demonstrated ability to manage projects and align multiple stakeholders. - Hands-on experience with healthcare systems, regulatory environments and communications dynamics in key markets. - Strong business communications acumen gained through experience in the pharmaceutical or biopharma sector. - Experience in planning and executing communication campaigns for regulatory milestones data announcements and congresses. - Demonstrated experience developing and executing external communications campaigns for patient and/or HCP audiences to support brand or disease education. - Experience leveraging digital engagement approaches, including social media influencers, to extend reach and influence. - Proven ability to lead brand launches with demonstrable impact. - Ability to build authentic relationships and trust with stakeholders across diverse markets. - Deep understanding of healthcare systems, regulatory environments, and market dynamics. - Exceptional English written and verbal communication skills, with the ability to distil complex scientific information into clear and compelling messages. - Effective management of multiple priorities in a fast-paced, matrixed environment. 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 Head of Emerging Indications is a senior leader in Oncology Medical Development, reporting to the Head of Oncology Medical Development. This “above-asset” position is accountable for shaping and executing clinical development strategy across emerging disease areas, with a strong focus on enabling enterprise growth through entry into new indications. The role provides leadership and oversight to multiple Global Medical Leads and drives delivery excellence across a portfolio of early- and late-stage programs. This leader plays a critical role in defining future portfolio direction through disease cluster strategy and active participation in business development activities. Responsibilities and Accountabilities - Portfolio Leadership and Emerging Indications Strategy - Define and lead disease cluster strategies to enable entry into new and emerging oncology indications, aligned with enterprise priorities. - Identify and shape opportunity spaces, integrating internal and external insights. - Serve as a key thought partner in portfolio prioritization and long-term disease cluster strategy. - Drive strategic decisions to ensure sustainable portfolio growth and differentiation. - Clinical Development Leadership and Execution Excellence - Provide oversight and direction to Global Medical Leads to ensure high-quality, timely execution of clinical programs. - Guide design, review, and governance of clinical study protocols, ensuring scientific rigor, feasibility, and regulatory alignment. - Ensure delivery of high-quality, credible data to support regulatory submissions, publications, and lifecycle strategies. - Embed a culture of accountability, urgency, and excellence in execution across programs. - Ensure optimal resource planning and deployment across the Emerging Indications portfolio. - Cross-Functional, End-to-End Leadership and Integration - Ensure integrated, end-to-end development strategies that align with regulatory and commercial objectives through seamless collaboration across Research, Early Development, Clinical Operations, Regulatory, Quantitative Sciences, Safety, Medical Affairs, and Commercial. - Business Development and External Engagement - Play a key leadership role in evaluation of in-licensing, out-licensing, and partnership opportunities. - Provide Medical Development expertise in due diligence, asset valuation, and integration planning. - Contribute to strategy development for multi-track business development initiatives within Oncology. - Governance, Compliance, and Operational Excellence - Participate/Lead governance forums, providing a strong Medical Development perspective. - Ensure adherence to ICH, GCP, and Astellas policies across all development activities. - Contribute to the establishment and continuous improvement of processes and SOPs. Qualifications - Advanced degree in life sciences, medicine, or related field. - 8–10+ years of experience in the pharmaceutical/biotechnology industry, including significant oncology clinical development experience across phases. - Strategic thinker with the ability to translate vision into actionable plans with accountability and urgency that integrates diverse perspectives. - Demonstrated experience leading global development teams and complex programs. - Proven ability to develop and execute clinical development strategies and regulatory submissions. - Strong cross-functional expertise spanning clinical, regulatory, safety, and commercial considerations. - Experience contributing to or leading business development assessments and due diligence. - Established track record in people leadership, talent development, and change management. - Exceptional communication skills with the ability to convey complex concepts clearly to the common denominator and influence across diverse stakeholders with keen cultural awareness. Preferred Qualifications - MD degree with board certification and clinical oncology practice experience. - Experience in thoracic oncology. - Exposure in related and complimentary functional areas (medical affairs, safety science, etc). - Experience managing multi-year budgets and resource allocation across complex portfolios. 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 External Innovation Partner, Oncology Research - Targeted Protein Degradation & Induced Proximity is a scientific leadership role that serves as an External Catalyst, connecting Astellas Oncology Research with leading external innovation ecosystems in targeted protein degradation, induced proximity, and degrader-conjugate science. This role proactively identifies, evaluates, and shapes external opportunities across: - PROTACs - Molecular glues - Monovalent/direct degraders - Degrader platforms - E3/UPS biology including CRBN, VHL, and novel E3 ligases - Target engagement - Proteomics/chemoproteomics - Structural and computational degrader design - Degrader Antibody Conjugates (DACs) - Next-generation induced-proximity technologies such as RIPTAC and TCIP - Other oncology-relevant targeted-delivery or induced-proximity modalities The role translates external scientific signals into research hypotheses, differentiation logic, critical-assumption questions, and scientific assessments that guide research strategy and support BD-led partnership discussions in close collaboration with internal research leaders. Responsibilities and Accountabilities - External Ecosystem Engagement & Catalytic Scouting: - Build trusted access to academic investigators, KOLs/KEEs, biotech founders, incubators, investors, CROs, tech-transfer offices, venture creation groups, and scientific consortia focused on TPD, induced proximity, oncology chemical biology, proteomics, and degrader-conjugate science. - Prioritize engagement with leading innovation ecosystems and global centers of excellence in degrader science, induced proximity, oncology research, chemical proteomics, and DAC/degrader-conjugate technologies. - Represent Astellas Oncology Research at major scientific conferences, innovation forums, targeted partnering events, and academic meetings to uncover early-stage opportunities before they become broadly visible. - Actively track scientific and company activity across PROTACs, molecular glues, monovalent/direct degraders, novel E3 ligase recruiters, CRBN/VHL biology, target engagement, proteomics/chemoproteomics, next-generation induced-proximity technologies such as RIPTAC and TCIP, and DACs. - Maintain dynamic hub heatmaps, KEE maps, company/platform landscapes, and opportunity pipelines that enable rapid triage and high-quality internal decision-making. - Scientific Opportunity Identification & Strategic Insight: - Identify high-impact external science, platform technologies, targets, mechanisms, and translational capabilities with potential relevance to Astellas oncology research priorities and future portfolio options. - Assess TPD and induced-proximity opportunities based on target biology, degradability, modality fit, E3/UPS strategy, mechanism of action, target engagement, proteomic selectivity, cellular pharmacology, DMPK/PK-PD, differentiation, competitive positioning, and development risk. - Evaluate platform-partnership opportunities for scientific maturity, scalability, target-ligase knowledge, assay/model access, reproducibility, IP/FTO considerations, and potential to unlock difficult-to-drug or previously inaccessible oncology targets. - For DAC or degrader-conjugate opportunities, assess tumor antigen selection, internalization/trafficking biology, targeting vehicle properties, linker-payload strategy, degrader payload mechanism, degradation readouts, tumor selectivity, safety liabilities, and fit with Astellas capabilities. - Translate early-stage innovation signals into strategic insights that support research prioritization, portfolio planning, and exploratory evaluation of external opportunities. - Cross-Functional Collaboration & Knowledge Integration: - Collaborate closely with Research Strategy Leads, Modality Intelligence Leads, Innovation Intelligence Analysts, and other subject-matter experts to ensure insights are shared and acted upon. - Support BD-led opportunity evaluation in collaboration with Business Development and relevant embedded partners by providing scientific framing, diligence questions, data-package interpretation, and strategic context. - Contribute to the development of intelligence infrastructure and best practices for horizon scanning, opportunity mapping, and external engagement across CI & RPM. Qualifications - Advanced degree (PhD, MD, MBA, or equivalent) in Oncology, Life Sciences, or a related field. - Minimum 8 years of experience in pharmaceutical R&D, external innovation, academic collaboration, or scientific partnering. - Strong understanding of oncology drug discovery, translational science, and modality platforms (e.g., next gen ADCs, engineered biologics, engineered small molecules). - Proven ability to engage with scientific leaders and navigate early-stage biotech and academic ecosystems. - Excellent communication skills with the ability to synthesize complex scientific information into strategic insights. - Prior experience in academic liaison, external innovation, or strategic scouting in pharma/biotech or venture ecosystems. - Familiarity with CI platforms, digital literature monitoring tools, and academic/biotech databases. - A strong network in academia or biotech focused on oncology. - Experience in competitive intelligence, scientific scouting, or innovation strategy within oncology. - Familiarity with academic-industry collaboration models and consortia-based innovation. - High digital literacy and comfort with landscape analytics, scientific intelligence platforms, and conference tracking tools. 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 As Lead, Strategic Initiatives, US, you will drive enterprise-level governance and strategic portfolio management for US Value Delivery. You’ll serve as a senior advisor, ensuring disciplined, transparent, and aligned decision-making across Medical Affairs and Commercial teams. Your work will shape how priorities are set and decisions are made, fostering alignment with global strategy and medical compliance. Role and Responsibilities: - Enterprise Governance & Decision Architecture: - Design, implement, and continuously improve the US Value Delivery governance framework. - Define and maintain decision rights, escalation protocols, and forum charters. - Prepare leadership forums (monthly governance, QBRs) to be decision-ready and outcome-focused. - Manage the secretariat function, ensuring agenda integrity, capturing decisions, and tracking follow-through. - Portfolio Management & Strategic Trade-offs: - Lead portfolio intake, prioritization, and trade-off processes. - Empower leaders to make informed decisions on sequencing, capacity, and investment. - Maintain a unified view of priorities, dependencies, and risks across the enterprise. - Apply and interpret medical guardrails in portfolio and governance decisions. - Enterprise Alignment to Global Strategy: - Champion US alignment with global strategy, translating global priorities for US leadership. - Ensure US decisions reflect global intent without duplicating global planning efforts. - Trusted Advisor Leadership: - Act as a strategic thought partner to the Strategic Operations Lead and US Market leadership. - Proactively identify and address enterprise risks, misalignments, and decision bottlenecks. - Guide leadership dialogue toward enterprise-wide outcomes rather than functional optimization. Core Competencies: - Enterprise governance design and facilitation - Portfolio management and prioritization frameworks - Executive advisory and decision-making support - Enterprise operating model design - Medical compliance and guardrail interpretation Leadership Expectations: - Foster a “One Astellas” mindset across Medical and Commercial teams. - Model courage and accountability in decision stewardship. - Drive outcomes through disciplined governance. - Build trust through transparency and integrity. Qualifications - Bachelor’s or Master’s degree in science, engineering, mathematics, decision science, or analytics - Minimum of 10 years of experience in forecasting, market research, competitive intelligence, and/or decision sciences role at a pharmaceutical company, or a consultancy focused on the biopharmaceutical industry - Understanding of the role of a global function within broader enterprise strategy - Previous experience in a global role or working with cross-functional teams across different regions/markets - Highly coachable/ thrives in an environment of continuous growth Preferred Qualifications: - Pharmaceutical Industry Experience in global mid-cap/large-cap company - MBA Location and Working Environment This position is based in Northbrook, Illinois. Remote work from anywhere in the US is available. At Astellas we recognize 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 optimize 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. 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 $161,928-243,500 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations). Flexible pay grade level based on candidate background and skillset.

Role Description Due to the expanding portfolio, we are looking for Medical Directors to join our clinical teams in late development oncology at Astellas. - Core member of the clinical team responsible for the design and execution of one or more clinical trials. - Serves as Medical Monitor with responsibility for safety monitoring on clinical studies. - Generates safety-related documents, such as medical monitoring reports. - Collaborates closely with the safety officer in writing and/or reviewing safety narratives, investigator letters, and other safety documentation for site-reported safety events. - Responsible for the medical aspects of all study-related documents, including clinical study protocol, informed consent forms, clinical database, safety committee charters, and clinical study reports. - Works with Development Scientists and Clinical Operation Leads to ensure efficient execution of clinical trials and acquisition of high-quality clinical data. - Supports functional level clinical development related initiatives as needed. - Leads and/or participates in scientific and medical training for team members and external clients, investigators, and site staff. - Reports to the Global Medical Portfolio Lead for Late Oncology. Qualifications - MD or MD/PhD - 5+ years experience in oncology clinical trial design and execution in a bio-pharmaceutical development organization or a balance of experience at an academic institution and a pharmaceutical company. - 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 - Board certified in Oncology or Oncology-related specialty (preferred). - Experience in solid tumors, preferably Gastro-Intestinal, Thoracic or Genito-Urinary (preferred). - Experience in late development oncology (Ph3) (preferred). - Direct experience leading global regulatory marketing authorization submissions and defense of those submissions (preferred). 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 Lead, Patient & Upstream Marketing is responsible for leading the strategy, development, and execution of patient-centric and upstream marketing initiatives to drive diagnosis, treatment initiation, and persistence for IZERVAY. - Provides strategic leadership and oversight of Direct-to-Consumer (DTC) marketing, patient engagement programs, and upstream healthcare provider (HCP) marketing. - Ensures patient activation and upstream demand generation efforts are integrated with broader brand strategy and commercial priorities. - Manages a team of three direct reports (2 Patient Marketers and 1 Upstream Marketer). - Accountable for delivering a high-impact, insight-driven, and compliant marketing approach that drives measurable business outcomes. Qualifications - Bachelor’s degree required; advanced degree (MBA preferred). - 10+ years of pharmaceutical/biotech experience with strong US brand marketing experience. - Proven experience in DTC marketing and campaign execution, including media planning and optimization. - Experience leading patient-centric initiatives (adherence, education, support programs). - Experience in HCP marketing, including non-personal promotion and/or congress engagement. - Demonstrated ability to lead teams and manage multiple priorities in a complex environment. - Strong analytical, strategic thinking, and communication skills. - Ability to work effectively across cross-functional teams and influence without authority. Requirements - Experience in ophthalmology, retina, or specialty markets. - Experience managing large marketing budgets and agency partners. - Experience in upstream/referral network development strategies. - Prior experience in launch or high-growth brand environments. 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 Establish an AI-enabled market research capability that accelerates insight generation, improves decision quality, and maximizes ROI—while maintaining methodological rigor, compliance, and human judgment. - Enable AI-augmented, always-on insight generation that complements primary market research. - Embed AI across the end-to-end MR lifecycle, improving speed to insight, learning velocity, and decision confidence. - Expand the breadth and depth of message/concept testing and creative optimization, with appropriate validation through PMR as needed. - Leverage historical research via an Insights Site to reduce duplication and improve insight reuse. - Improve forecasting decision enablement through stronger linkage between demand/segmentation insights and forecast assumptions. - Implement a dedicated AI-enabled forecasting capability/tool to enhance brand and portfolio forecasting. - Develop team capabilities through coaching, mentoring, and onboarding new talent. - Manage resource allocation and support professional growth within the Chapter. - Represent the Insights Practice as a subject matter expert and contribute to Pods and Value Teams as needed. - Demonstrate a Growth Mindset that seeks feedback, adapts quickly, and models continuous improvement. - Collaborate and focus on outcomes, proactively seeking the right answers and solutions across brands. - Oversee vendor projects and ensure alignment with organizational objectives. Qualifications - Bachelor’s or Master’s degree in science, engineering, mathematics, decision science, or analytics. - Minimum of 10 years of experience in forecasting, market research, competitive intelligence, and/or decision sciences role at a pharmaceutical company, or a consultancy focused on the biopharmaceutical industry. - Demonstrated experience building, managing, and training teams around a specific area of SME expertise. - Understanding of the role of Insights function within broader enterprise strategy. - Demonstrated ability to develop talent and foster a culture of continuous learning and improvement. - Previous experience working with Global cross-functional teams across multiple brands/TAs. - Strong stakeholder management skills with the ability to influence at the executive level. - Exceptional people leadership, mentorship, and coaching skills. Requirements - Master’s degree in Statistics or Economics (preferred). - Pharmaceutical Industry Experience in global mid-cap/large-cap company (preferred). 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 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)