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Astellas Pharma jobs in Northbrook, IL - 36 jobs

  • Operational Audit Lead

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    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 ***************** This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply. Purpose: This role is responsible for conducting risk assessment activities and developing appropriate audit programs for complex and varied global and regional topics (operational, financial, compliance, and/or IT). This role is responsible for managing internal audit projects including budgeting, timeline monitoring, completing fieldwork testing, and directing other internal audit members and/or co-sourcing resources to complete assigned areas of the audit programs. The role is responsible for preparing final audit reports, conduct thorough follow-up work on identified issues to ensure remediation actions are completed, and will support in communications with Astellas Top Management and the Audit and Supervisory Committee. Essential Job Responsibilities: Supporting the Operational Audit Business Partner, the role will be responsible for: 1. Annual Risk Assessment and Continual Risk Monitoring Assist in the identification and evaluation of the organization's risks and provide input to the development of the Annual Audit Plan. Participate in assigned risk interviews with key stakeholders, formally summarize results, and identify key themes and trends to propose annual audit projects. Conduct independent research and leverage personal network to evaluate pharmaceutical industry risks and monitor for regulatory changes and emerging risks. Maintain the global risk register and support the Audit Business Partner in longer term audit planning. 2. Internal Audit Project Management Lead complex global and regional projects as assigned. Responsibilities include end-to-end project delivery (e.g., planning, budgeting, fieldwork, and reporting): Lead and conduct interviews with stakeholders in order to evaluate risks and review internal documents to deliver Audit Planning Summary and Audit Scope Memorandum for each project to the directors of Internal Audit. Prepare audit budgets, timelines, and resource allocations for review by the directors of Internal Audit. Prepare and complete a draft audit program and fieldwork testing plan to assess the design and operating effectiveness of internal controls. Manage audit fieldwork processes including walkthroughs, workpaper documentation, and identification of audit observations. Communicate results via written audit reports and oral audit presentations to key stakeholders and senior management. Develop and maintain productive client, staff, and management relationships. Provide advice and counsel to management to help improve internal processes and controls. 3. Co-source oversight Responsible to provide day to day oversight of third-party co-source members supporting assigned audit projects, including: Ensuring roles and responsibilities are well understood across the team. Timely delivery of workpapers and agreed deliverables, including results which meets the quality requirements aligned to the Institute of Internal Auditors (IIA) Standards and Framework. Managing budgets of individual projects and escalating potential overruns 4. Other Responsibilities Coordinate and partner with other governance functions including Risk Management, Compliance, and Quality Assurance to ensure risk coverage and avoid duplication. Lead or perform other internal initiatives to achieve the vision of Internal Audit.
    $35k-65k yearly est. 1d ago
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  • Partner, US Contract Management

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    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 ***************** This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply. Purpose: Negotiates and manages contracts with approved customers to support Market Access & Established Brands' goal of ensuring profitable formulary access for Astellas products. The incumbent will manage the entire lifecycle of the contract, develop pricing offers/proposals for customers in collaboration with Astellas' Field Sales and Market Access & Established Brands Account Management; and review, edit and negotiate contract language and amendments with customers to minimize risk to the company. Essential Job Responsibilities: Develop pricing offers/proposals in collaboration with Market Access's Field Sales and Market Access & Established Brands Account Management teams. Ensure appropriate approvals are received from and documented by Strategic Pricing Committee (SPC) prior to generating any new offers, or renewals or modifications of existing contracts. Ensure compliance of internal policies and procedures with respect to development of pricing offers, especially as it relates to established pricing guidelines and exceptions to pricing guidelines. Review, edit and negotiate contract language and amendments (in collaboration with Field Sales and Market Access & Established Brands Account Management teams) with customers to minimize unfavorable business terms and risks to the company. Work collaboratively with the Legal department to ensure timely review of proposed changes in contract language and provide appropriate context to Legal to ensure proper review of contract language. Maintain offers/contracts in Contracts & Pricing contract database to ensure that agreements are being submitted, negotiated and renewed well in advance of contract expiration and/or customer deadlines. Acts as a lead liaison for Field Sales and Market Access & Established Brands Account Management teams, and a trusted advisor. Support them by maintaining offers/contracts in Contracts & Pricing contract database and reporting of major contracts & pricing terms and conditions. Assist in the development of their periodic business reviews with internal leadership and customers. Work with Finance to ensure appropriate price reporting, appropriate validation and calculation of payments in Model N revenue management system, and to ensure that timely payments to customers are remitted in accordance with the contract terms. Proactively communicate any contracts and pricing modifications to internal business partners within C&P, Finance, Sales, Account Management, Legal, Supply Chain, and any other interested stakeholders. Provide guidance to C&P Pricing and Analytics team to ensure appropriate analysis of deals and accurate budgeting and forecasting. Participates in strategy sessions with Market Access & Established Brands and Brand Marketing teams on new contracting initiatives. Participates in annual Budget and Mid-Term Plan (MTP) planning process with Pricing Analytics, Marketing, Market Access & Established Brands, Forecasting and Finance teams. Review and understand price protection arrangements with customers, where applicable, and explain them to other C&P teams and internal customers as necessary to ensure proper analysis of deal.
    $148k-275k yearly est. 1d ago
  • Sales Rep/SR Sales Representative, Pets - Chicago, IL

    Boehringer Ingelheim Group 4.6company rating

    Chicago, IL job

    Performs responsibilities in generating sales, market share and profitability results for assigned territory with appropriate direction. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities Meets sales objectives and supports attainment of district and regional/ business unit performance objectives Development of market, customer, and industry knowledge along with further development of technical product knowledge is imperative. Effective utilization and management of internal and external resources is expected. Perform customer/consumer training meetings and support convention and professional association business building opportunities. Maintains and utilizes expert product knowledge and highly effective selling skills in order to influence customers to support the use of BIAH promoted products. Executes brand strategies to ensure a consistent company sales and marketing message. Uses appropriate BIAH Sales Training techniques to facilitate the sale. Utilizes CRM tools to create pre-call plans. Keeps current territory records concerning activities; communicates timely, accurately and meaningfully with Management. Utilizes CRM tool and supporting analysis to plan activity, report, monitor samples and maintain customer records. Analyzes territory information to optimize customer calls and create annual business plan for execution. Monitors market conditions for changes that impact our business. Completes objectives including achieving sales plan while operating within specified expense budget. Successfully completes all sales training requirements. Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIAH's excellent reputation within the animal health community and internally. Requirements Sales Representative: Bachelor's degree from an accredited institution required. Minimum of two to five (2-5) years of relevant field sales experience in a competitive selling environment required, or a minimum of two (2) years as a degreed, licensed and practicing Doctor of Veterinary Medicine in a clinic or animal health organization. Animal health or related industry experience preferred Ability to work with general supervision General knowledge of industry practices, techniques, and standards Experience presenting to various size audiences Must demonstrate an aptitude and desire to sell and gain market share Ability to learn technical product knowledge quickly Key competencies include: interpersonal skills, drive, resilience, persuasive skills, teamwork, organization skills and strong verbal and written communication skills PC skills and the ability to use mobile applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate Valid driver's license and an acceptable driving record to drive a company leased vehicle or authorized rental vehicle Senior Sales Representative: Bachelor's degree from an accredited institution required. Minimum of five-plus (5+) years of relevant field sales experience in a competitive selling environment required Animal health or related industry experience preferred Ability to work with general direction Complete understanding and application of principles, concepts, practices and standards Full knowledge of industry practices Experience presenting to various size audiences Must demonstrate an aptitude and desire to sell and gain market share Ability to learn technical product knowledge quickly Key competencies include: interpersonal skills, drive, resilience, persuasive skills, teamwork, organization skills and strong verbal and written communication skills PC skills and the ability to use mobile applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate Valid driver's license and an acceptable driving record to drive a company leased vehicle or authorized rental vehicle Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.
    $113k-155k yearly est. 60d+ ago
  • Neuroscience Specialist - Joliet, IL

    Otsuka America Pharmaceutical Inc. 4.9company rating

    Joliet, IL job

    Otsuka America Pharmaceutical Inc. is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In its evolved customer engagement model, a Neuroscience Specialist engages healthcare providers (HCPs) using in-person, virtual, and digital tools, offering expertise on products and their approved conditions. This model enhances patient, caregiver, and HCP experiences by focusing on local care delivery, aiming to improve patient care and provide a superior experience. The Neuroscience Specialist will report directly to the respective Area Business Lead, coordinating with cross-functional colleagues in Medical (MSLs), Market Access (HSAMs), and Patient Support (PELs) under appropriate guidelines. This individual will serve as the primary point of contact for HCP customers and should possess a broad range of expertise, capable of addressing complex on-label information based on approved content. **Position Overview** This position is designed to enhance customer engagement, thought leadership, and business planning within the organization. The role involves proactive outreach to healthcare professionals (HCPs), facilitating discussions, and elevating insights to inform strategic decisions. Below is a detailed overview of the key responsibilities and objectives associated with this position: + Personally engage customers through various virtual or digital tools. + Direct customers to other colleagues, such as Customer Service Specialists (CSS), as needed. + Ensure customer requests are met and solicit feedback on the quality of engagement. + Facilitate speaker programs to share knowledge and insights. + Organize local provider groups for discussions on experiences and outcomes with local/regional leaders. + Elevate opportunities and feedback to the Area Business Lead, including local market insights. + Collaborate compliantly with the ecosystem team to adjust targeting and call point plans. + Action on insights collected from customer-facing roles to inform local strategy and business goals. **Key Responsibilities** + Conduct proactive outreach to HCPs on topics such as product access, on-label information, and established patient care guidance. + Engage customers through various virtual or digital tools and direct them to other colleagues (e.g., CSS) as needed. + Facilitate speaker programs and organize local provider groups for discussions on experiences and outcomes with local/regional leaders. + Elevate opportunities and feedback to the Area Business Lead, including local market insights to inform local strategy and business goals. **Experience &** **Qualifications** + A minimum of 2 years of pharmaceutical or medical device sales experience. + Must reside within a commutable distance of 50 miles from the primary city in the sales territory. + Previous cross-functional industry experience in commercial life sciences or related industry. + 4 or more years of experience working in a sales role with HCPs, ideally representing multiple products. + Ability to work in an ambiguous environment undergoing transformation. + Proven track record in coaching, training, and mentoring peers or others. + Demonstrates a commitment to ethical business practices, an understanding of regulatory standards, and the ability to execute business activities in compliance with Company policies and guidance. + Ability to assimilate and communicate complex clinical and product information. **Key Sales Capabilities** + **Territory Analysis / Business Planning** + Uses competitive data and business reports to track progress and uncover opportunities, including sales data and promotional budget + Displays knowledge of territory and business conditions that impact sales results to establish near term priorities for his/her territory business plan + Responds compliantly to competitive threats and opportunities + Educates office staff on payer guidelines and reimbursement procedures to increase pull through + Effectively utilizes promotional materials + **Selling Skills, Engagement & Account Pull Through** + Maintains ongoing awareness of internal support team resources available throughout the ecosystem and utilizes appropriately + Applies market and industry knowledge to overcome objections and influence prescribing habits during the total office call + Identifies territory professional groups to network and ensure access/exposure to potential key opinion leaders + Builds strong relationships with all key office/practice personnel and focuses on patient health in conversations with all staff members. Takes personal responsibility for follow-through and providing value to the accounts by providing accurate information in response to their needs + Delivers effective and balanced office calls and sales presentations utilizing the appropriate approved marketing materials and technical references (e.g. studies, package inserts, etc.) with clarity and confidence to help HCPs enhance patient outcomes; demonstrates competent product knowledge of own product and competition \#LI-Remote **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $107,362.00 - Maximum $166,750.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
    $107.4k yearly 8d ago
  • Specialist, Supplier Relationship Management

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    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 ***************** This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply. Purpose: Responsible for designing, implementing, and documenting a comprehensive IT Supplier Relationship Management (SRM) Program for DigitalX. This role will also be responsible for managing key supplier relationships, overseeing supplier performance, stakeholder satisfaction, and governance to drive performance, innovation, and compliance across the DigitalX supplier base. Essential Job Responsibilities: Program Design & Implementation: Develop and launch a global IT SRM framework and processes that include segmentation, governance, performance management, and innovation tracking. Create and maintain documentation including SOPs, playbooks, and governance charters. Collaborate with cross-functional stakeholders (IT, Procurement, Legal, Risk, Finance) to align SRM processes with enterprise goals. Supplier Relationship Management Serve as the primary point of contact for a portfolio of IT suppliers. Lead regular performance reviews, issue resolution, and joint improvement initiatives with suppliers. Monitor supplier compliance with contractual obligations, SLAs, and regulatory requirements. Contract & Risk Oversight Manage contract lifecycle activities including renewals, amendments, and negotiations. Partner with Legal and Risk teams to ensure governance and risk mitigation strategies are in place. Track and report on supplier risk indicators and audit findings and implement corrective actions as needed. Technology & Reporting Utilize SRM platforms (e.g., Vizibl, ServiceNow, Ariba) to automate reporting and enable real-time visibility into supplier performance. Develop dashboards and analytics to support strategic decision-making and executive reporting.:
    $49k-79k yearly est. 1d ago
  • Legal Partner, R&D Transactions

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    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 ***************** This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply. Purpose: The Legal Partner, R&D Transactions is responsible for providing legal support and legal services in relation to certain R&D legal transactions of the Research, Technology and Manufacturing (T&M), Development, Medical Affairs, and Rx+ functions. The position holder also provides legal support and advice for other functions where required. Essential Job Responsibilities: Providing practical, timely, proactive, strategic, high quality legal services for the Research, T&M, Development, Medical Affairs, and Rx+ functions on R&D transactional matters taking into account the global objectives of the organization and the unique and varying global, local and regional legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk Providing legal and strategic support for a broad range of R&D transactions for Research and managing the strategic drafting, negotiating, and consummating a broad range of complex agreements in support of Research, including research collaborations and alliances, consortiums, sponsored research, material transfers, research licenses, HTS library exchange, consulting services, research services, CRO services, advisory boards and councils, data sharing and data licensing, investigator-initiated studies, regulatory and quality agreements Providing legal and strategic support for a broad range of R&D transactions for T&M, including supply agreements, manufacturing contracts, collaborations, service agreements, and other contracts. This may include but is not limited to support to business clients on (i) contract drafting and negotiations with potential business partners and collaborators and (ii) strategic projects and key initiatives of the T&M function Providing legal and strategic support for a broad range of R&D transactions for Development and managing the strategic drafting, negotiating, and consummating of a broad range of complex agreements in support of Development, including agreements for clinical trials, assay development, companion diagnostics, expanded access, compassionate use, patient recruitment, informed consents, non-interventional studies, sponsorships and grants, advisory boards, data sharing and data licensing, investigator-initiated trials, and regulatory, quality, and pharmacovigilance agreements Providing legal and strategic support for a broad range of transactions for Medical Affairs and managing the strategic drafting, negotiating, and consummating of a broad range of complex agreements in support of Medical Affairs, including investigator-sponsored research agreements and escalations related thereto, Astellas-sponsored medical affairs study agreements, collaborative research, and CRADAs Providing legal and strategic support for a broad range of transactions for Rx+ and managing the strategic drafting, negotiating, and consummating of a broad range of complex agreements in support of Rx+ and medical devices, including consulting agreements, confidentiality agreements, service agreements, master services agreements, development agreements, and clinical trial agreements Providing updates to management and business clients on changes in legal developments affecting the pharmaceutical industry, especially in the research and development fields, and the innovative new technologies and coordinating with other leaders in the Legal Functional Unit, as may be appropriate Identifying, participating in, and contributing to contract enhancement initiatives for business clients, including by suggesting, preparing, and reviewing new templates of contracts, check lists, guidance, etc. Aligning, coordinating, and working closely with the members of the Legal Transactions Tower and other members of the Legal Functional Unit and the GC & CECO Division Retaining, supervising, and directing outside counsel effectively, and efficiently managing legal expenses consistent with approved global budget, coordinating closely with the Legal Team Lead, R&D Transactions Other projects as may be requested by the Legal Team Lead, R&D Transactions Overnight travel, including international travel, as needed
    $84k-151k yearly est. 1d ago
  • Partner, US Patient Support Programs Operations (Retina)

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    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 ***************** This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply. Purpose: This individual is responsible for developing the Patient Support Program (PSP) strategy for assigned product/therapeutic area. This role will be primary contact for the Market Access Lead (MAL) and brand to navigate product life cycle position, patient needs, and industry/healthcare policy dynamics to optimize brand-level patient access and affordability solutions. This role will continuously evaluate opportunities to change, modify, or discontinue programs based on dynamic. This individual will provide market access subject matter expertise to brand stakeholders and inform training and development of brand-level PSP materials/education to be used/distributed by field sales. Additionally, role will lead development of brand-level tools/resources, materials, and training to be leveraged by the ARM teams. This individual will lead/support incremental PSP brand and PAAS operational needs. Essential Job Responsibilities: Partners with brand team and Market Access partners to develop annual product patient access and affordability strategy and plans. Collaborate with brand stakeholders and MAL to monitor external and internal dynamics impacting the overall PSP strategies and sustainability. In addition, stay abreast of the evolving access and affordability market and reimbursement model innovation, and leverage these insights to develop clear strategies and tactics to meet patient needs. Partner with brand team to inform training and development of PSP related materials/education for sales representatives, providers and patients for assigned products (materials and training to be led by the brand). Lead development of brand-level patient access and affordability training and materials to be leveraged by ARM teams. Develop new process and technology implementations to leverage data, analytics, and technology to monitor, inform, and improve PSP outcomes and impact. Compellingly communicates brand level PSP vision, priorities, direction, and results to cross functional teams and leadership including Brand Heads. Lead/support PSP operations as determined by brand and PAAS needs. Forecasts budget related to reimbursement HUB operations and implements strategies to manage spend within the relevant product marketing budgets. Conduct annual review of essential program services and continuously evaluate opportunities to change, modify or discontinue programs based on changing market dynamics among payers, distributors, patients and physicians, or legal and government policies.
    $34k-44k yearly est. 1d ago
  • Development Scientist, Oncology Clinical Development

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    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 ***************** This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply. Purpose: The Development Scientist will 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, Asset Lead, and Development Physician. The role 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 expertise and experience in clinical development to enable increased participation in division and portfolio level initiatives. Essential Job Responsibilities: Responsible and accountable for activities related to all current and planned clinical trials on assigned development programs (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting). Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussions and timely decision making. Serves on the clinical sub-team with Clinical lead, Operations Lead, and Medical Monitor/Development Physician; supports preparation of clinical development plans, site identification and management, and DESC meetings. Under the guidance of the development physician/med lead, performs medical monitoring activities (e.g., review, analyze, and triage patient data, generate study reports) Can independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plans. Partners with Clinical lead in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries. Together with the clinical lead and Product Responsible Person, prepares 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 on enabling appropriate enrollment into clinical studies or registries. Collaborates cross-functionally to create, review, and/or present clinical content at internal or external meetings. Supports engagement with current and future clinical study sites (e.g., SIVs, investigator meetings, conferences, steering committee, advisory board meetings). Shows relevant 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 groups for site and vendor feasibility, trial set up, and data monitoring. Leads the execution of contracts, particularly for investigator meetings and advisories. Supports efforts to develop strategic partnerships with Key External Experts (KEEs) Serves as key partner for the Development Division in assessment of candidates within discovery, identifying opportunities and potential risks in the context of future development strategies based on modality, indication, unmet need, competitive landscape, and clinical characteristics. May represent clinical development and assist with clinical assessment 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 required. This position is typically an individual contributor role, but may have direct reports based on experience, scope, accountabilities and complexity of assigned development programs. If the position has direct reports, will align with Astellas guidelines for span of control and organizational levels. This position reports to the IO Development Medical Lead/Head of disease area strategy.
    $70k-94k yearly est. 1d ago
  • Site Management Lead (Associate Director)

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    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 ***************** Purpose and Scope: 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). Essential Job Responsibilities: Accountable for the identification, onboarding, training and development of monitoring clinical trial talent to support the planning, initiation, execution and close-out of clinical trials with operational excellence. Individuals in this role will also provide leadership/mentorship, in a matrix setting, for activities that support clinical trial teams. This position is accountable to the Head, Clinical Site Management Early Development, and will provide input into departmental budget and resourcing strategies, including development and implementation of global processes and procedures, non-drug product initiatives, and coaching of monitoring staff during execution of development trials. Responsible for resource planning, recruitment, mentoring, development and retention of site monitoring & management staff Manage and allocate monitoring resources to trials and monitor performance on assigned trials for monitoring staff (up to 12 direct reports) May manage and allocate monitoring resources in more than one region globally Provides direction, leadership and learning opportunities to enhance individual development of direct reports in support of providing best-in-class site monitoring across the portfolio Provide oversight and guidance in completing monitoring and site management related activities according to agreed timelines and quality standards, including identifying areas for additional training and development Oversee 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 Oversee and provide guidance to Clinical Operations Leads and/or Clinical Trial Leads in regional Key Opinion Leader (KOL) interactions, communications; and submissions to Health Authorities within their region/country of responsibility, aligned to the overall asset strategy. Responsible for compliance of direct reports with training and identification and support for any training needs Facilitate and support global trial monitoring operational standards and tools Anticipates, recognizes and facilitates problem solving to support site monitoring & management staff and rapidly addresses and mitigates potential performance issues Collaborates effectively with Portfolio Operations Leads, Clinical Operations Leads and SORD leadership to ensure site monitoring & management staff are delivering as expected and to ensure common framework and standards across clinical programs and trials Ability to collaborate with peers in Clinical Operations across Early and Late-Stage Clinical Operations, cross-functionally and regionally, including relevant counterparts globally, to align on best practices for clinical monitoring staff May lead process improvements relevant to clinical trial monitoring and site management Contribute to development and implementation of best-in-class monitoring/site management standards and processes
    $40k-82k yearly est. 1d ago
  • Senior Manager (Partner), US Field Force Deployment and Sales Force Effectiveness

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    **Senior Manager (Partner), Strategic Field Force Deployment and Sales Force Effectiveness** 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 **************** . **Purpose:** The **Senior Manager (Partner), Strategic Field Force Deployment and Sales Force Effectiveness** drives Astellas' sales strategy by developing and implementing long-term planning processes, targeting tools and customer insights, sales impact KPIs and metrics to optimize sales force performance and execution. Collaborating with Sales, Marketing, Market Access and Commercial Operations leadership, this role ensures sales activities align with brand strategies and delivers data-driven insights to support critical business decisions. By fostering cross-functional partnerships, this position equips sales teams with resources to maximize customer engagement and drive sales success. **Responsibilities and Accountabilities:** + Develop Strategic Sales Plans: Lead the creation of data-driven customer targeting strategies, call plans and tools to enhance Sales Force execution for internal sales organizations. + Support field activation strategies that align with omnichannel marketing objectives to enhance healthcare professional (HCP) engagement + Assist in the implementation of Next Best Engagement (NBE) solutions, ensuring seamless integration with Veeva systems + Support precision customer engagement workstreams through data-driven omnichannel insights in collaboration with multiple cross departmental stakeholders Field Analytics, Sales, Brand, Incentive Compensation, Data Enablement, Customer Insights and Field Technology and DigitalX teams + Deliver Actionable Insights: Analyze sales data to generate key insights and provide actionable recommendations, including triggers, alerts and Next Best Action (NBA) suggestions, to Sales and Marketing leadership for business critical decision-making. + Develop Sales Force Effectiveness and KPIs: Lead sales force alignments, targeting, segmentation, dynamic alerts and Next Best Action (NBA) suggestions, while supporting brand analytics and reporting teams to optimize Sale Force execution. + Innovate Targeting Practices: Introduce innovative targeting and call planning methodologies by leveraging industry trends, benchmark, dynamic alerts and Next Best Action (NBA) suggestions to enhance Sales Force effectiveness and execution. + Drive Cross-Functional Alignment: Collaborate with Sales, Brand, Customer Insights and other external partners to align on objectives, apply industry best practices and manage vendors to support strategic initiatives. + Oversee Quarterly Call Plans: Lead the development, communication and implementation of quarterly call plans, incorporating key performance metrics to track execution and call plan adherence. + Manage Call Plan Refinement: Own the field refinement and feedback platform, ensuring timely updates to call plans, delivering post-refinement change summaries and provide related execution training. + Manage External Partnerships: Oversee relationships with vendors, consultants and commercial partners to support and achieve business objectives. + Optimize Resource Allocation: Provide insights to maximize the impact of product details and samples, enhancing sales performance across products and teams. + Train Sales Teams: Educate sales teams on reporting tools, enhancing their use for targeting and call planning management and strategic decision-making. + Sales Leadership Support: Actively participate in preparation for National Sales Meetings, Leadership Forums and industry conferences including strategy and communication development and presentation of Strategic Field Force Deployment driven initiatives, program launches and related end-user trainings **Quantitative Dimensions:** + Call Planning Quality: Measured by feedback from customers and cross-functional teams on the effectiveness, timeliness and quality of quarterly target lists and call plans. + Sales Performance Reporting: Responsible for accuracy, timeliness and end user experience of both standardized and ad-hoc reports, dashboards and targeting tools, based on customer and stakeholder feedback. + Sales Force Optimization: Key metrics including customer reach/frequency, impact, workload balance across territories and overall sales performance and execution. + Insight Generation: Quality and timeliness of actionable recommendations, evaluated by Sales and Brand leadership and cross-functional feedback. + Project Milestones: Achievement of key milestones for major strategic initiatives and partner-supported projects. **Organizational Context:** The Senior Manager (Partner) reports to the Director, Strategic Field Force Deployment and Sales Force Effectiveness. This role collaborates extensively with Field Analytics, Sales, Brand, Incentive Compensation, Data Enablement, Customer Insights and Field Technology and DigitalX teams. There are no direct reports, but the position leads business critical cross-functional teams and manages vendor and commercial partner relationships. This role operates within the Sales Operations and Analytics job family. **Qualifications Required:** + Bachelor's degree + 7+ years of analytical experience in data analysis and reporting within the pharmaceutical or healthcare industry + Strong organizational and project management skills with attention to detail and ability to manage cross-functional initiatives + Excellent interpersonal and communication skills to interact effectively with all levels, including senior leadership and management + Working knowledge of programming techniques and environments (e.g., SQL, SAS, Microsoft Access, Excel/VBA macros and AWS workspaces) + Proficiency in Microsoft Word, Excel and PowerPoint in a Windows environment + Experience working in Veeva CRM + Knowledge of statistical modeling techniques (e.g., regression, ROI, correlation, AI/ML) and their application in analytical projects + Working understanding of industry and technology trends, implications and applications + Strong communication, multitasking and problem-solving skills with a proactive mind-set and approach + Ability to work independently in a fast-paced environment with minimal supervision + Experience in targeting, call planning and dynamic alerts within the pharmaceutical industry **Preferred Skills:** + MBA in business or sciences + Management experience leading teams or projects + Strong working knowledge of third-party syndicated data sources (e.g., Symphony Health, IQVIA, Wolters Kluwer, SDI Health, etc.) + Experience with Veeva, Cognos, Spotfire or QlikView **Working Environment:** + 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. + Experience working globally not required. **Salary Range** **:** $122,500 - 192,500 (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 Flexible grade level based on candidate background and skillset \#LI-TD Category Commercial Operations Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans
    $122.5k-192.5k yearly 60d+ ago
  • Real World Data Scientist, Oncology (Associate Director)

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    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 ***************** This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply. Purpose: We are hiring an experienced real-world data scientist to join our Real-World Data Science (RWDS) team. As an Associate Director of RWDS, you will be an analytic researcher informing and conducting Real World Data (RWD) studies at any time in the drug lifecycle. You will work directly within the RWDS team to execute observational studies for internal and external consumption and partner closely with Development, Medical Affairs, and Pharmacovigilance/Pharmacoepidemiology colleagues in their research. Additionally, you will collaborate closely with others in RWDS, Biostatistics and the broader Quantitative Sciences & Evidence Generation department to enhance our RWD and analytics offerings. RWDS is multidisciplinary and provides RWE strategic input, study design, statistical and programming support to projects. Team members apply their unique knowledge, skills and experience in teams to deliver decision-shaping real-world evidence. Essential Job Responsibilities: Provide best-in-class data science support to Astellas drug development programs & marketed products in relation to RWD Design of observational studies (primary and/or secondary data) Execute (program and analyze) observational studies using in-house RWD or oversee vendors or other RWDS staff in executing observational studies Write, review, or contribute to key study documents to ensure optimal methodological & statistical presentation. These documents include, protocols, analysis plans, tables and figure (TLF) specifications, study reports, publications Ensure efficient planning, execution and reporting of analyses Advise as subject matter expert in specific data access partnerships Represent the company on matters related to RWD analysis at meetings with regulatory authorities, key opinion leaders and similar experts/bodies as needed Contributes to vendor selection with partner functions Participate in the creation and upkeep of best practices, tools/macros, and standards related to methods, data and data analysis at Astellas Collaborate with RWDS and Biostatistics colleagues and cross-functional teams in Development, Medical Affairs and Pharmacovigilance Mentor and guide junior members of the RWD Analytics team
    $75k-104k yearly est. 1d ago
  • Rheumatology Clinical Account Specialist-Chicago

    UCB 4.3company rating

    Chicago, IL job

    Make your mark for patients To strengthen our Rheumatology Sales Team, we are looking for a talented individual to fill the position of: Rheumatology Clinical Account Specialist - Chicago ( Downtown) About the role As a Rheumatology Clinical Account Specialist (CAS) you will be responsible for driving demand for the assigned product, by reinforcing the clinical features of the product and UCB value within an assigned territory; engaging and building relationships with clinical decision makers and office support staff to create the best experiences for patients living with severe immunologic diseases who are treated in the home care setting. Who you'll work with Attain sales goals and objectives by product volume as well as other key accountabilities such as reach/frequency with assigned call plan stakeholders Develops a strong understanding and awareness of the patient journey of care, including the unique needs of patients within the at-home care setting. Work within the prioritized customer call plan to establish professional working relationships with HCP and support staff. Offer an outstanding patient experience with our product by communicating clinical information on assigned UCB product and relevant patient support services What you'll do Establishing an understanding of the local ecosystems, including the payor environment, including pharmacy benefits; demonstrating the ability to successfully navigate the complexities of local care delivery systems and models, comprised of multiple payers, with varying degrees of restriction and barriers to patient access for the assigned UCB product. Maintaining a thorough understanding of the competitive marketplace and drivers of prescriber decisions. Demonstrating consistent application of the UCB Patient Value Strategy principles by establishing collaborative and team-oriented working relationships, integrating with local UCB ecosystem business partners, in a matrix environment encompassing Field Reimbursement Managers, Immunology Clinical Account Specialist, Partnership Leads, Regional and National Account Executives and Medical Science Liaisons Knowing when and how to bring in the right expertise at the right time from other UCB matrix roles based on the customer need or opportunity at hand Conducting account related activities such as profiling, call planning, reviewing UCB sales data, related to at-home administration with assigned stakeholders Interested? For this role we're looking for the following Minimum Qualifications: Bachelor's degree BA/BS 3 + years direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry Must have a valid US Driver's License and with no more than 3 moving violations in the past 2 years Must reside within assigned territory Preferred requirements: Experience selling injectable products Experience in calling on Rheumatologists Discussing therapeutic strategies to inform and influence decision makers Developing and applying clinical and business expertise, and effective selling skills Executing marketing strategies at the local level Demonstrated understanding of managed care landscape and how it influences/impacts business Expected Salary Range: $128,000-168,000k based on experience Please note: UCB's offered salary will be based on individual candidate qualifications and/or location and may fall outside the expected range. Are you ready to ‘go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! About us UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science. Why work with us? At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless explicitly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office. UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
    $36k-54k yearly est. 10d ago
  • Clinical Site Manager

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    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 ***************** Purpose: A Clinical Site Manager (CSM) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols. Responsibilities may include assisting with or primary responsibility for: Site Selection Pre-trial assessment Site level Study Participant recruitment/retention plans Site Activation/Initiation On-site and remote monitoring Overall site relationship management in collaboration with other sponsor roles that interact with the site Close-out activities Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role. Essential Job Responsibilities: Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials. Develops meaningful site relationships through consistent collaborative communication and engagement. May participate in site feasibility and/or pre-trial site assessment visits. Attends/participates in investigator meetings as needed. May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensures study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study. Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. Ensure ongoing adequacy of site (facilities, staff) for trial conduct. Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas. Ensures site non-IMP study supplies are adequate for trial conduct. Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed. Oversees the appropriate destruction of clinical supplies. Ensures site staff complete data entry and resolve queries within expected timelines. Ensures validity and completeness of data collected at trial sites. Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate. Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management. Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits. Prepares trial sites for close out, conduct final close out visit. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.
    $32k-54k yearly est. 1d ago
  • Global Information Security Operations Lead

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    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 ***************** Purpose and Scope: The Information Security Operations Lead plays a critical role in protecting Astellas' global technology landscape. This leader is responsible for driving 24x7 operational excellence across security monitoring, incident response, vulnerability management, and attack surface reduction. Reporting directly to the Global Head of Information Security and Global Infrastructure, the role ensures global consistency in detecting, analyzing, and mitigating threats across enterprise, cloud, and hybrid environments. This leader oversees a diverse, global team comprised of internal employees, contractors, and managed service partners, ensuring seamless integration of capabilities, tools, and processes to safeguard Astellas' digital ecosystem. Location: Global (US, UK, India). Essential Job Responsibilities: Operational Leadership Lead the global Security Operations function (SOC), ensuring continuous monitoring, detection, and response to cyber threats. Oversee incident response activities, including triage, containment, recovery, and post-incident reviews. Manage enterprise security domains such as endpoint protection, email security, vulnerability management, and attack surface management. Conduct regular red, blue, and purple team exercises to validate and improve resilience. Maintain strong situational awareness of emerging threats and vulnerabilities relevant to the pharma sector. Team & Partner Management Lead a hybrid global team of full-time employees, contractors, and managed services, ensuring clear roles, accountability, and alignment. Oversee managed SOC and incident response service providers, ensuring high-quality performance and continuous improvement. Mentor and develop internal team members, fostering a culture of collaboration, learning, and operational discipline. Optimize team capacity, skills, and resource allocation to balance in-house and outsourced capabilities. Technology and Process Enablement Oversee key security technologies, including SIEM, SOAR, EDR, and threat-intelligence platforms. Drive automation and orchestration to reduce mean time to detect (MTTD) and mean time to respond (MTTR). Partner with Global Infrastructure, Cloud, and Digital teams to embed security into core operations and transformation programs (e.g., Zero Trust, SD-WAN, AI-driven operations). Define and monitor operational KPIs and dashboards to measure the effectiveness and efficiency of global security operations. Governance, Risk, and Compliance Align operations with Astellas' enterprise security framework, NIST CSF, ISO 27001, and internal risk management policies. Maintain and continuously improve operational playbooks, response procedures, and escalation paths. Support global audits (SOX, J-SOX, internal, and external) and ensure timely remediation of findings. Contribute to continuous control improvement and risk reduction initiatives across the enterprise.
    $75k-98k yearly est. 1d ago
  • Lead, R&D Business Analysis (Director)

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    Lead, R&D Business Analysis 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 ***************** This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply. Purpose: We are seeking a dynamic and experienced leader to join our team. The Lead, R&D Business Analysis plays a dual leadership role in driving the digital transformation of pharmaceutical R&D. This role requires strong people management and cross-functional leadership skills, a collaborative mindset, and the ability to drive results in a fast-paced environment. The primary responsibility of the Lead, R&D Business Analysis is to serve as a people manager, responsible for developing talent, managing team capacity, and fostering excellence across the community of Business Analysts who support R&D digital initiatives. The Lead, R&D Business Analysis will be assigned to lead a cross-functional team for the management of a portfolio of relevant R&D digital capabilities. They will be working across scientific, operational, data, and technology domains to define vision, guide execution, and ensure business value realization for key digital products and platforms Essential Job Responsibilities: Manage a team of Business Analysts who support digital initiatives across R&D. In conjunction with Pod Captains, manage resource allocation and capacity planning to meet portfolio demands while balancing team workload and priorities. Coach and mentor team members to strengthen core capabilities in Astellas values and behaviors, R&D business analysis, digital product management, stakeholder engagement and communication, and agile delivery. Foster a collaborative and innovative team culture, encouraging open communication and idea sharing Partner with HR and functional leaders to attract, retain, and develop top digital talent aligned with evolving R&D business needs. Lead a cross-functional matrixed team focused on a specific portfolio of digital capabilities for R&D, ensuring alignment with relevant functional goals and company objectives. Lead the development and monitoring of Objectives and Key Results (OKRs). Collaborate with cross-functional stakeholders and R&DX leadership team to set OKRs, track progress, and address concerns. Continue to mature agile way of working, through ceremonies including sprint planning, backlog refinement, retrospectives, regular stand-ups, and use of our Agile Enterprise applications (Azure DevOps) for managing epics, features, user stories and sprints. Monitor project timelines, budgets, and resources, ensuring projects are delivered on time and within budget. Collaborate with business stakeholders and technical teams to identify innovation opportunities including the use of AI, GenAI, Automation and Advanced Analytics.
    $105k-149k yearly est. 1d ago
  • Network Engineer, TechX

    Astellas Pharma, Inc. 4.9company rating

    Astellas Pharma, Inc. job in Northbrook, IL

    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 ***************** This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply. Purpose: We are seeking a skilled and motivated Network Engineer to join our team. As a Network Engineer, you will play a crucial role in designing, implementing, and maintaining our network infrastructure. Your expertise will contribute to the seamless operation of our communication systems and ensure optimal performance. Essential Job Responsibilities: * Network Design, Architecture and Implementation: * Collaborate with cross-functional teams to design and deploy network solutions based on organizational requirements. * Configure and manage network hardware, including routers, switches, firewalls, and wireless access points. * Monitor network performance, availability, and reliability. * Decision maker for the strategy and direction of technology and processes within your area of responsibility. * Oversee the design and architecture of network systems to ensure they are efficient, scalable, and secure. * Ensure that network operations comply with industry standards and regulations. * Technical Support and Troubleshooting: * Provide end-to-end technical support for network-related issues. * Respond to inquiries promptly and efficiently. * Troubleshoot and resolve network incidents. * Collaboration and Communication: * Work closely with internal and external stakeholders to ensure smooth network operations. * Communicate effectively with team members, clients, and vendors. * Participate in meetings and discussions related to network planning and improvements. * Work with network equipment and service vendors to ensure quality service * Security and Compliance: * Implement and maintain security protocols, including firewalls and intrusion detection systems. * Stay up-to-date with industry trends, technologies, and best practices to continuously improve network infrastructure and security
    $68k-89k yearly est. 1d ago
  • Director/Sr. Director, Identity & Security Engineering

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    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 ***************** Purpose & Scope: We are seeking an experienced leader to serve as the Identity & Security Engineering Lead. This role will be responsible for defining strategy, leading teams, and ensuring operational excellence across our Microsoft identity management platforms while also overseeing broader security engineering domains including cloud security, OT security, application security, and infrastructure security. A critical focus area will be advancing our Multi-Factor Authentication (MFA), Conditional Access, and Privileged Access Management (PAM) capabilities to enable secure, seamless user experiences. Beyond identity, this leader will drive security engineering excellence across cloud, OT, and enterprise platforms. This role will be accountable for global delivery through a hybrid workforce model, managing both internal engineering teams and external service providers/partners across multiple regions and time zones. Operating within an agile delivery model, the Identity & Security Engineering Lead will ensure identity and security engineering capabilities are delivered with speed, adaptability, and business alignment. The role may be based in the United States, Canada, United Kingdom, Poland, Mexico, India, or Japan, with global responsibilities across all regions. Responsibilities and Accountabilities: Strategic Leadership · Define and execute the enterprise vision for Microsoft Identity platforms (Active Directory, Azure AD / Entra ID, M365 Identity Services, MFA, Conditional Access, PAM). · Lead strategy and delivery across broader security engineering domains including cloud security, OT security, and infrastructure/application security. · Drive a global MFA-first strategy, embedding Zero Trust principles across the enterprise. · Ensure identity and security engineering programs support digital transformation, cloud adoption, and regulatory compliance. Operational Excellence · Ensure global reliability and performance of MFA and Conditional Access policies. · Automate identity lifecycle management (provisioning, de-provisioning, access reviews, PAM). · Deliver security engineering solutions for cloud platforms (Azure, AWS, GCP) and OT/critical infrastructure environments. · Apply agile delivery methodologies to accelerate delivery, manage backlogs, and adapt quickly to evolving requirements. · Manage service delivery performance across both internal teams and external vendor partners. · Risk, Compliance & Governance · Partner with GRC to ensure identity and security engineering controls meet NIST CSF, ISO 27001, SOX, HIPAA, EU AI Act, and other regulatory frameworks. · Lead audit and compliance programs across identity, cloud, and OT security domains. · Anticipate and mitigate emerging risks by adapting MFA and security engineering strategies. Collaboration & Influence · Serve as a trusted partner across infrastructure, applications, OT, business stakeholders, and senior executives. · Position MFA, identity, and security engineering as key enablers of business productivity and compliance. · Represent the function in enterprise-wide programs including global network refresh, cloud adoption, OT modernization, and M&A integrations. · People & Talent Leadership · Lead and mentor a global team of internal and external resources, ensuring alignment and accountability across multiple regions and time zones. · Foster agile, cross-functional teams that collaborate across infrastructure, applications, and business domains. · Manage vendor partnerships and enforce accountability for quality, SLAs, and innovation. · Develop succession plans, training paths, and career opportunities in Microsoft identity, MFA, and advanced security engineering. · Promote a culture of inclusion, agility, innovation, and continuous improvement.
    $111k-165k yearly est. 1d ago
  • Lead, Legal and IP Business Operations

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    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 ***************** Purpose and Scope: The Lead, Legal & IP Business Operations position is a senior leadership role within the GC&CECO Chief of Staff (CoS) Office. This position serves as the senior operational lead for the Legal and IP functions, with primary accountability for strategic execution, operational planning, cross-functional coordination, and vendor and financial oversight. As the designated operational business partner to Legal and IP leadership, this role ensures alignment between functional strategies and enterprise-level processes, including those owned by Finance, HR, and Procurement. The role is critical to driving transparency, fiscal discipline, vendor management effectiveness, and business process optimization across the Legal and IP Divisions. It also plays a key role in promoting standardization, efficiency, cost control, and continuous improvement in how Legal and IP operate globally. Additionally, the role oversees the use and performance of legal operations technologies, ensuring Legal and IP are supported by an effective, scalable, and cost-efficient technology toolset, including matter management and spend systems that support business needs. Essential Job Responsibilities: Strategic & Operational Leadership Serve as the operational lead and execution partner to Legal and IP leadership, translating strategic priorities into coordinated business operations. Align Legal and IP operating plans with CoS Office goals supporting Legal, IP, Ethics & Compliance, and Quality Assurance. Drive process standardization, efficiency improvements, and enterprise-level operational consistency across legal support functions. Develop and monitor operational KPIs that support performance transparency and continuous improvement. Outside Counsel & Vendor Program Management Lead global outside counsel and vendor operations, including firm onboarding/offboarding, scope and rate negotiation, and adherence to outside counsel guidelines. Manage preferred provider governance, performance metrics, and firm-level compliance. Implement operational frameworks that optimize law firm engagement, enhance value, and reduce variability in spend and process. Collaborate with Procurement, Legal and IP to enforce vendor governance and automate key workflows. Financial Oversight & Workforce Planning Oversee Legal and IP headcount planning, including FTE tracking, hiring plan alignment, and payroll budget management. Own the Legal and IP financial planning cycle, including budget development, quarterly forecasting, variance tracking, and cost performance analysis. Conduct deep analysis of spend at the matter, firm, and category level to inform cost control, forecasting accuracy, and strategic resource allocation. Partner with Finance to ensure clear reporting, forecast reliability, and alignment to corporate financial governance. Program & Project Execution Lead the execution of cross-functional initiatives focused on operational transformation, tooling implementation, and department-wide efficiencies. Define objectives, timelines, and outcomes; manage stakeholder engagement; ensure sustainable adoption and measurable value. Support strategic planning cycles, road mapping, and OKR/goal development in partnership with Legal and IP leadership. Ensure Legal and IP are supported by an effective, scalable, and cost-efficient technology toolset, including matter management and spend systems that support business needs. Cross-Functional Business Partnering Coordinate with CoS solutions team leads and, as needed, with Finance, HR, and Procurement to ensure alignment of Legal and IP budgets, workforce planning, and vendor operations with enterprise processes and standards. Represent Legal and IP in governance forums focused on financial performance, operational risk, and enterprise alignment. Support organizational design, workforce planning, and operational oversight in collaboration with internal and enterprise stakeholders.
    $35k-65k yearly est. 1d ago
  • Legal Partner, R&D Transactions

    Astellas Pharma, Inc. 4.9company rating

    Astellas Pharma, Inc. job in Northbrook, IL

    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 ***************** This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply. Purpose: The Legal Partner, R&D Transactions is responsible for providing legal support and legal services in relation to certain R&D legal transactions of the Research, Technology and Manufacturing (T&M), Development, Medical Affairs, and Rx+ functions. The position holder also provides legal support and advice for other functions where required. Essential Job Responsibilities: * Providing practical, timely, proactive, strategic, high quality legal services for the Research, T&M, Development, Medical Affairs, and Rx+ functions on R&D transactional matters taking into account the global objectives of the organization and the unique and varying global, local and regional legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk * Providing legal and strategic support for a broad range of R&D transactions for Research and managing the strategic drafting, negotiating, and consummating a broad range of complex agreements in support of Research, including research collaborations and alliances, consortiums, sponsored research, material transfers, research licenses, HTS library exchange, consulting services, research services, CRO services, advisory boards and councils, data sharing and data licensing, investigator-initiated studies, regulatory and quality agreements * Providing legal and strategic support for a broad range of R&D transactions for T&M, including supply agreements, manufacturing contracts, collaborations, service agreements, and other contracts. This may include but is not limited to support to business clients on (i) contract drafting and negotiations with potential business partners and collaborators and (ii) strategic projects and key initiatives of the T&M function * Providing legal and strategic support for a broad range of R&D transactions for Development and managing the strategic drafting, negotiating, and consummating of a broad range of complex agreements in support of Development, including agreements for clinical trials, assay development, companion diagnostics, expanded access, compassionate use, patient recruitment, informed consents, non-interventional studies, sponsorships and grants, advisory boards, data sharing and data licensing, investigator-initiated trials, and regulatory, quality, and pharmacovigilance agreements * Providing legal and strategic support for a broad range of transactions for Medical Affairs and managing the strategic drafting, negotiating, and consummating of a broad range of complex agreements in support of Medical Affairs, including investigator-sponsored research agreements and escalations related thereto, Astellas-sponsored medical affairs study agreements, collaborative research, and CRADAs * Providing legal and strategic support for a broad range of transactions for Rx+ and managing the strategic drafting, negotiating, and consummating of a broad range of complex agreements in support of Rx+ and medical devices, including consulting agreements, confidentiality agreements, service agreements, master services agreements, development agreements, and clinical trial agreements * Providing updates to management and business clients on changes in legal developments affecting the pharmaceutical industry, especially in the research and development fields, and the innovative new technologies and coordinating with other leaders in the Legal Functional Unit, as may be appropriate * Identifying, participating in, and contributing to contract enhancement initiatives for business clients, including by suggesting, preparing, and reviewing new templates of contracts, check lists, guidance, etc. * Aligning, coordinating, and working closely with the members of the Legal Transactions Tower and other members of the Legal Functional Unit and the GC & CECO Division * Retaining, supervising, and directing outside counsel effectively, and efficiently managing legal expenses consistent with approved global budget, coordinating closely with the Legal Team Lead, R&D Transactions * Other projects as may be requested by the Legal Team Lead, R&D Transactions * Overnight travel, including international travel, as needed
    $84k-151k yearly est. 60d+ ago
  • Development Scientist, Oncology Clinical Development

    Astellas Pharma 4.9company rating

    Astellas Pharma job in Northbrook, IL

    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 **************** . This position is based in Northbrook, Illinois. Hybrid work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply. **Purpose:** The Development Scientist will 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, Asset Lead, and Development Physician. The role 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 expertise and experience in clinical development to enable increased participation in division and portfolio level initiatives. **Essential Job Responsibilities:** + Responsible and accountable for activities related to all current and planned clinical trials on assigned development programs (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting). + Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussions and timely decision making. + Serves on the clinical sub-team with Clinical lead, Operations Lead, and Medical Monitor/Development Physician; supports preparation of clinical development plans, site identification and management, and DESC meetings. + Under the guidance of the development physician/med lead, performs medical monitoring activities (e.g., review, analyze, and triage patient data, generate study reports) + Can independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plans. + Partners with Clinical lead in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries. + Together with the clinical lead and Product Responsible Person, prepares 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 on enabling appropriate enrollment into clinical studies or registries. Collaborates cross-functionally to create, review, and/or present clinical content at internal or external meetings. + Supports engagement with current and future clinical study sites (e.g., SIVs, investigator meetings, conferences, steering committee, advisory board meetings). + Shows relevant 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 groups for site and vendor feasibility, trial set up, and data monitoring. + Leads the execution of contracts, particularly for investigator meetings and advisories. + Supports efforts to develop strategic partnerships with Key External Experts (KEEs) + Serves as key partner for the Development Division in assessment of candidates within discovery, identifying opportunities and potential risks in the context of future development strategies based on modality, indication, unmet need, competitive landscape, and clinical characteristics. + May represent clinical development and assist with clinical assessment 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 required. + This position is typically an individual contributor role, but may have direct reports based on experience, scope, accountabilities and complexity of assigned development programs. If the position has direct reports, will align with Astellas guidelines for span of control and organizational levels. + This position reports to the IO Development Medical Lead/Head of disease area strategy. **Qualifications Required:** + Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 7-8 years clinical, scientific/research, pathology, or industry experience; combination of academia and industry is acceptable. + Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early-stage development through approval) from initial study design, study start-up & execution to regulatory submissions (INDs, BLAs, NDAs) within U.S. and ex-U.S. + 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 (e.g., 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. + Highest level of scientific integrity and impeccable work ethics. + Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail. + Able to travel ~25%, with international travel as required. **Salary Range** $180K - $230K (NOTE: Final salary could be more or less, based on experience) **Preferred:** + MD., PharmD, or other relevant master's degree. + Knowledge and proficiency related to Immuno-Oncology clinical research **Working Environment:** + 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. **Salary Range** $170,450 - $267,850 (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** Category Oncology Development Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans
    $70k-94k yearly est. 51d ago

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