Associate Director, Project Management Clinical Development

Applied Physicist for CMS Inner Detectors

CERN

What you'll do You will develop algorithms, FPGA firmware, and data acquisition systems for CMS online luminosity measurement, beam monitoring, and Tracker calibration for the High Luminosity LHC, and coordinate such developments. This involves Integrating and commissioning back-end systems for luminosity and tracking detectors, enabling real-time data processing and precision luminosity measurements. Your responsibilities - Develop, deploy, and maintain firmware and real-time algorithms for back-end electronics across multiple CMS board platforms, including systems for the Fast Beam Conditions Monitor (FBCM), Inner and Outer Tracker online luminosity, to support luminosity measurement, beam monitoring, and lumi-trigger generation. - Validate front-end detectors (including FBCM and Tracker modules) and back-end electronics through laboratory testing, ensuring end-to-end system performance from detector to data output. - Execute detector functional tests during detector integration at the Tracker Integration Facility, ensuring system readiness prior to installation. - Organise and lead test campaigns, including preparatory activities, on-site coordination of participants, and systematic validation of hardware, firmware, software and detector response. - Lead studies of detector efficiency, calibration quality, and operational stability, through measurements and simulations. - Coordinate technical interfaces across detector, trigger, timing, and data acquisition domains to ensure system integration. - Supervise and mentor students and fellows, including recruitment and structured technical guidance. - Anticipate upcoming technical and operational needs, structuring workflows, preparing infrastructure, and engaging with collaborating institutes to ensure continuity of operations. Your profile - Hands-on experience with detector laboratories, electronics prototyping, and test beam operations. - Strong experience in FPGA firmware development (VHDL or similar HDL) and real-time data processing, ideally in particle physics detectors. - Demonstrated ability to integrate and troubleshoot complex systems spanning firmware, software, and detector hardware, from the detector frontend through to the data output. - Experience with data analysis, detector efficiency and calibration studies, and the statistical methods relevant to performance evaluation. - Experience in supervising or mentoring students or junior colleagues, including selecting candidates and adapting guidance to individual strengths. - PhD or equivalent relevant experience in the field of Physics or a related field. You are asked to provide at least one reference letter as part of your application. Your skills - Simulation, design and development of trigger, data acquisition chains: including FPGA-based electronics. - Simulation, design and development of (parts of) detectors. - Testing and validation of detector, accelerator and beam line components. - Analysis and optimisation of detector performance: through the interpretation of simulation and experimental data. - Solid understanding of electronics. - Strong organisational and planning skills, with the ability to anticipate needs, coordinate across teams, and lead activities under time pressure. - Effective communicator across multidisciplinary teams, able to maintain constructive working relationships and coordinate technical interfaces with diverse contributors. - Has a structured and organised approach towards work; is able to set priorities and plan tasks with results in mind. - Contributes to promoting a positive atmosphere in the team through an optimistic and constructive attitude; addresses issues. - Sets ambitious, challenging but realistic goals; is ready to take initiatives and calculated risks in the interest of CERN. - Makes timely decisions that balance systematic analysis with decisiveness; deals with difficulties in a timely manner. - Spoken and written English, with a commitment to learn French. Medical hazard Exposure to electromagnetic fields under certain exposure conditions. Given the occupational health risks associated with this position, the selected candidate must obtain medical clearance before a contract offer is confirmed. Employment conditions - A valid driving licence. - Work in Radiation Areas. - Interventions in underground installations. - Work during nights, Sundays and official holidays, when required by the needs of the Organization. Ideal start date: 01/10/2026 Contract duration (in months): 48 Grade range: 6 Benchmark job: 200140 - Applied Physicist

Associate Director, Scientific Communications Rare Disease

Kyowa Kirin

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary of Job: The Associate Director, Scientific Communications, Rare Disease is responsible for supporting the development, execution, and continuous optimization of scientific communications initiatives for the Rare Disease Medical Affairs organization in North America. The role leads the planning, development, review, and implementation of scientific materials and educational programs that support Medical Affairs strategic objectives and ensure the accurate, balanced, and compliant dissemination of scientific information. Core focus of the role includes overseeing the development and lifecycle management of Field Medical materials; creating scientific content and supporting the execution of Medical Advisory Boards, Scientific Symposia, Medical Education initiatives, and conference-related deliverables; and managing external Medical Communications agencies and Medical Education partners to ensure the timely delivery of high-quality, scientifically accurate materials. The Associate Director collaborates cross-functionally with Medical Affairs and other internal stakeholders to ensure scientific communications activities are aligned with organizational priorities and compliant with applicable policies and regulatory requirements. Essential Functions: * Support data disclosure and scientific dissemination activities associated with clinical trial milestones and major medical congresses for U.S. Medical Affairs. * Provide content and editorial support for regional publications and scientific presentations. * Ensure regional publication priorities are represented in the global publication plan and support localization of global publication activities to meet regional needs. * Collaborate with global and regional Medical Affairs teams to ensure consistency of scientific messaging and alignment with regional medical strategy. * Partner with external medical communications agencies and vendors to manage the quality, timelines, and budgets of scientific communications deliverables. * Support external expert engagement and steering committee activities, including coordination of content review and approval workflows. * Support scientific and medical operations, including advisory board planning and execution, medical information initiatives, and Medical Science Liaison (MSL) training. * Represent Medical Affairs at Medical Review Committee (MRC) and Promotional Review Committee (PRC) meetings, as needed, ensuring materials are scientifically accurate, current, appropriately substantiated, and properly referenced. * Ensure all scientific communications activities are conducted in compliance with applicable SOPs, policies, regulatory requirements, ICMJE recommendations, Good Publication Practice (GPP) guidelines, and company compliance standards. * Perform additional duties and special projects as assigned. Job Requirements: Education Advanced degrees in life sciences, health sciences, pharmacy, medicine, nursing, or a related scientific discipline (MD, PharmD, PhD, DNP, or equivalent) required.  Experience * Minimum of seven (7) years in the pharmaceutical, biotechnology, or medical communications industry within Medical Affairs or Scientific Communications. * Minimum of three (3) years supporting Scientific Communications, Publications, or Medical Communications functions. * Demonstrated success developing and executing scientific communication initiatives, including field medical materials, advisory boards, scientific symposia, medical education programs, publications, and congress deliverables. * Proven ability to collaborate with cross-functional stakeholders and manage external medical communications agencies and vendors to deliver high-quality scientific materials. * Background supporting publication planning, scientific dissemination, and data disclosure activities associated with clinical development and medical congresses. * Familiarity with medical, promotional, and publication review processes within a regulated pharmaceutical or biotechnology environment. * Rare Disease experience is strongly preferred. Technical Skills * Working knowledge of scientific communications, publication planning, Good Publication Practice (GPP) guidelines, International Committee of Medical Journal Editors (ICMJE) recommendations, and applicable regulatory requirements. * Excellent written and verbal communication skills, with the ability to effectively communicate complex scientific information to diverse internal and external audiences and facilitate cross-functional collaboration. * Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), Microsoft Teams, and SharePoint. * Skilled in using Veeva Vault MedComms, Veeva PromoMats, publication management systems, and other platforms supporting scientific content development, review, approval, and distribution. * Strong scientific writing, editing, literature evaluation, and content development skills, with the ability to translate complex scientific information into clear, accurate, audience-appropriate materials. * Ability to leverage AI-enabled tools and platforms to support scientific content development, literature synthesis, data visualization, and operational efficiency while ensuring compliance with company policies and regulatory requirements. * Demonstrated project management and organizational skills, with the ability to manage multiple priorities and deliver high-quality work within established timelines. Non-Technical Skills Strong analytical skills, attention to detail, and ability to manage/prioritize multiple projects from concept to completion in a fast-paced environment.  Strong written and oral communication skills.  Ability to work well in cross-functional teams (across geography and culture) with a group of people with diverse skill sets and personalities.  Team player, flexible and adaptable. Ability to build good working relationships, both inside and outside the organization.  Self-starter.  Must possess integrity and be innovative in how they work on a day-by-day basis.  Has a passion for personal learning and development to be able to grow with the company.  Cultural sensitivity and ability to develop consensus within a multinational organization.  Physical Demands: Normal office environment with prolonged sitting and extensive computer work Working Conditions: Minimal domestic travel required (<10%), primarily for conference attendance or key meetings; occasional weekend travel may be required.   The anticipated salary for this position will be $180,000 to $196,900.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-JC1

Associate Director, Clinical Quality Management

Kyowa Kirin

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations. Essential Functions: Risk-Based Quality Management (RBQM) Leadership •    Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance. •    Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors. •    Integrate RBQM principles into study planning, execution, oversight, and close-out activities. •    Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy. Central Risk Identification, Monitoring & Mitigation •    Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks. •    Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials. •    Oversee centralized risk monitoring and trending to enable early detection of critical risks. •    Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons  Learned & Risk Library Management (Core Ownership) •    Establish and maintain a centralized Clinical Risk Library, capturing: o    Known and emerging risks o    Root causes o    Mitigation strategies o    Effectiveness of controls •    Lead lessons learned activities across trials, audits, inspections, and CAPAs. •    Ensure lessons learned are: o    Systematically captured o    Analyzed for trends o    Fed back into RBQM planning, SOPs, training, and future studies •    Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness. Quality Oversight & Regulatory Compliance •    Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs. •    Provide centralized quality oversight across trials, CROs, and vendors. •    Support audit and inspection readiness activities, including: o    Risk-based inspection preparation o    Impact assessments o    CAPA development and effectiveness checks Vendor & CRO Risk Oversight •    Design and implement risk-based oversight strategies for CROs and external vendors. •    Monitor vendor performance using quality metrics and risk indicators. •    Lead or support quality governance discussions with external partners. •    Ensure vendor-related risks are integrated into the central risk library and lessons learned framework. Data-Driven Quality & Continuous Improvement •    Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making. •    Generate enterprise-level risk trend reports and insights for senior leadership. •    Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned. •    Champion a culture of proactive quality and continuous improvement across Clinical Operations. Cross-Functional Collaboration & RBQM Expertise •    Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance. •    Provide RBQM training and coaching to study teams and cross-functional stakeholders. •    Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics. •    Participate as an observing member on assigned study teams to provide real-time quality and risk support. SOP Management & Governance Support •    Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates. •    Support governance activities, senior management reporting, and quality metrics standardization. •    Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support. Requirements: Education •    Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required) •    Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred) Experience •    10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM •    Demonstrated experience leading enterprise or cross-study risk management frameworks •    Strong background in audit/inspection readiness, CAPA management, and vendor oversight •    Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements Technical Skills •    Expertise with RBQM tools, centralized monitoring systems, and risk analytics •    Experience defining and using KRIs, QTLs, and quality metrics •    Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI) •    Exposure to AI or predictive analytics for quality monitoring (preferred) Working Conditions: Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines. The anticipated salary for this position will be $175,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton