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The candidate will also drive digital transformation initiatives, evaluating InsurTech solutions such as telematics-based pricing, AI-driven claims automation, and predictive analytics for risk segmentation.</p>\n<p>The role requires deep industry knowledge and strategic consulting skills to advise insurers on optimizing personal lines products, navigating compliance requirements, and implementing emerging technologies.</p>\n<p>This is an exciting opportunity to work with leading insurers on high-impact projects, leveraging data-driven strategies and InsurTech solutions to reshape the future of personal lines insurance.</p>\n<p>Responsibilities:</p>\n<ul>\n<li>Support Client and Internal Project Teams with a mix of the following capabilities:</li>\n</ul>\n<p><strong>Strategic Consulting &amp; Client Advisory</strong></p>\n<ul>\n<li>Act as a trusted advisor to top-tier insurers on personal lines insurance products, including homeowners, auto, renters, and umbrella.</li>\n</ul>\n<ul>\n<li>Lead product rationalization efforts, optimizing insurers&#39; 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The candidate will also drive digital transformation initiatives, evaluating InsurTech solutions such as telematics-based pricing, AI-driven claims automation, and predictive analytics for risk segmentation. Additionally, they will support regulatory advisory projects, ensuring compliance with state DOI regulations, NAIC model laws, and evolving legislative changes.</p>\n<p>The ideal candidate will have 10+ years of P&amp;C insurance product management or consulting experience, strong expertise in personal lines pricing, underwriting, and compliance, and familiarity with technology platforms like Guidewire, Duck Creek, and Majesco. Preferred qualifications include CPCU, AINS, ARM, Lean Six Sigma, or PMP certifications.</p>\n<p>This is an exciting opportunity to work with leading insurers on high-impact projects, leveraging data-driven strategies and InsurTech solutions to reshape the future of personal lines insurance. Join us and contribute to strategic innovation, regulatory excellence, and digital transformation in the insurance industry.</p>\n<p>**Key Responsibilities:*</p>\n<ul>\n<li>Act as a trusted advisor to top-tier insurers on personal lines insurance products, including homeowners, auto, renters, and umbrella.</li>\n<li>Lead product rationalization efforts, optimizing insurers’ portfolios to reduce complexity, enhance profitability, and improve customer experience.</li>\n<li>Drive new product development, leveraging telematics, usage-based insurance (UBI), embedded insurance, and AI-driven pricing models.</li>\n<li>Develop and implement product run-off strategies, ensuring compliance, financial stability, and seamless transition for policyholders.</li>\n<li>Guide insurers through regulatory advisory initiatives, ensuring product strategies align with state DOI regulations, NAIC model laws, and evolving consumer protection standards.</li>\n</ul>\n<p>**Regulatory Compliance &amp; Market Strategy:*</p>\n<ul>\n<li>Advise on state and federal regulations, helping clients navigate rate filings, compliance risks, and policyholder protections.</li>\n<li>Manage engagements related to state DOI rate filings, competitive benchmarking, and regulatory impact assessments.</li>\n<li>Provide insights on emerging legislative changes (e.g., climate risk mandates, AI-driven underwriting guidelines, and telematics regulations).</li>\n</ul>\n<p>**InsurTech Enablement &amp; Digital Transformation:*</p>\n<ul>\n<li>Partner with technology teams to implement digital underwriting, AI-based risk models, and automation tools.</li>\n<li>Evaluate and recommend InsurTech solutions such as:</li>\n<li>Telematics-based pricing (e.g., Cambridge Mobile Telematics, Arity)</li>\n<li>AI-driven claims processing (e.g., CCC Intelligent Solutions, Snapsheet)</li>\n<li>Fraud detection &amp; predictive analytics (e.g., Shift Technology, FRISS)</li>\n<li>Customer experience &amp; digital distribution (e.g., Cover Genius, Trov)</li>\n<li>Support insurers in modernizing core platforms, working with vendors like Guidewire, Duck Creek, and Majesco.</li>\n</ul>\n<p>**Claims Transformation &amp; Risk Management:*</p>\n<ul>\n<li>Assist clients in claims process optimization, leveraging automation, AI, and predictive analytics for faster claims adjudication.</li>\n<li>Develop strategies for fraud detection, litigation management, and claims efficiency improvements.</li>\n<li>Work with claims and risk teams to align product design with evolving risk trends (e.g., climate change impact, cyber risks in personal lines, and increased litigation costs).</li>\n</ul>\n<p>**Project Leadership &amp; Stakeholder Engagement:*</p>\n<ul>\n<li>Lead cross-functional consulting engagements involving actuarial, underwriting, IT, claims, and distribution teams.</li>\n<li>Develop and present strategic recommendations to C-suite executives, supporting data-driven decision-making.</li>\n<li>Manage multiple client engagements, ensuring timely delivery, regulatory alignment, and measurable business impact.</li>\n</ul>\n<p>**Requirements:*</p>\n<ul>\n<li>Education: Bachelor’s degree in Business, Finance, Insurance, or a related field (MBA, CPCU, or AINS preferred).</li>\n<li>Experience: 5+ years in P&amp;C insurance product management, consulting, or strategy roles, with a strong focus on personal lines.</li>\n<li>Industry Certifications (Preferred):</li>\n<li>CPCU (Chartered Property Casualty Underwriter) – Deep expertise in P&amp;C insurance.</li>\n<li>AINS (Associate in General Insurance) – Strong foundational knowledge of insurance operations.</li>\n<li>ARM (Associate in Risk Management) – Specialization in risk assessment and mitigation.</li>\n<li>Lean Six Sigma or PMP – For project management and operational efficiency.</li>\n<li>Technical Expertise:</li>\n<li>Deep knowledge of personal lines product development, pricing, underwriting, and risk management.</li>\n<li>Experience with product rationalization, run-off strategies, and market repositioning.</li>\n<li>Strong understanding of state insurance regulations, rate filings, and DOI compliance.</li>\n<li>Familiarity with InsurTech solutions, AI-driven pricing models, and claims automation technologies.</li>\n<li>Proficiency in data analytics tools (e.g., SQL, Python, Tableau, Power BI) for actuarial and risk modeling.</li>\n<li>Consulting &amp; 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Development</li>\n</ol>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">XML job scraping automation by <a href=\"https://yubhub.co\">YubHub</a></p>","url":"https://yubhub.co/jobs/job_5bcc89fa-9d8","directApply":true,"hiringOrganization":{"@type":"Organization","name":"Capgemini","sameAs":"https://www.capgemini.com/","logo":"https://logos.yubhub.co/capgemini.com.png"},"x-apply-url":"https://jobs.workable.com/view/mvzXqcoduTy4EZoqSvcyxM/hybrid-senior-p%26c-insurance-product-management-specialist-in-charlotte-at-capgemini","x-work-arrangement":"hybrid","x-experience-level":"senior","x-job-type":"full-time","x-salary-range":null,"x-skills-required":["Product management","Insurance","Personal lines","Pricing","Underwriting","Compliance","Regulatory strategy","InsurTech","Digital transformation","Data analytics","SQL","Python","Tableau","Power BI","Agile methodologies","Lean Six Sigma","Customer journey mapping","Product lifecycle management","Digital transformation strategies"],"x-skills-preferred":["CPCU","AINS","ARM","PMP","Telematics-based pricing","AI-driven claims processing","Fraud detection & predictive analytics","Customer experience & digital distribution"],"datePosted":"2026-04-24T14:16:28.607Z","jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Charlotte"}},"employmentType":"FULL_TIME","occupationalCategory":"Finance","industry":"Insurance","skills":"Product management, Insurance, Personal lines, Pricing, Underwriting, Compliance, Regulatory strategy, InsurTech, Digital transformation, Data analytics, SQL, Python, Tableau, Power BI, Agile methodologies, Lean Six Sigma, Customer journey mapping, Product lifecycle management, Digital transformation strategies, CPCU, AINS, ARM, PMP, Telematics-based pricing, AI-driven claims processing, Fraud detection & predictive analytics, Customer experience & digital distribution"},{"@context":"https://schema.org","@type":"JobPosting","identifier":{"@type":"PropertyValue","name":"YubHub","value":"job_70e37318-27b"},"title":"Senior P&C Insurance Product Management Specialist","description":"<p>We are seeking a Senior Property &amp; Casualty Insurance Product Manager – Personal Lines with expertise in product rationalization, new product development, product run-offs, regulatory strategy, InsurTech enablement, and claims transformation.</p>\n<p>Key responsibilities include leading product portfolio optimization, rate filings, and competitive market assessments. The candidate will also drive digital transformation initiatives, evaluating InsurTech solutions such as telematics-based pricing, AI-driven claims automation, and predictive analytics for risk segmentation. Additionally, they will support regulatory advisory projects, ensuring compliance with state DOI regulations, NAIC model laws, and evolving legislative changes.</p>\n<p>The ideal candidate will have 10+ years of P&amp;C insurance product management or consulting experience, strong expertise in personal lines pricing, underwriting, and compliance, and familiarity with technology platforms like Guidewire, Duck Creek, and Majesco. Preferred qualifications include CPCU, AINS, ARM, Lean Six Sigma, or PMP certifications.</p>\n<p>This is an exciting opportunity to work with leading insurers on high-impact projects, leveraging data-driven strategies and InsurTech solutions to reshape the future of personal lines insurance. Join us and contribute to strategic innovation, regulatory excellence, and digital transformation in the insurance industry.</p>\n<p>**Key Responsibilities:*</p>\n<ul>\n<li>Strategic Consulting &amp; Client Advisory*</li>\n<li>Act as a trusted advisor to top-tier insurers on personal lines insurance products, including homeowners, auto, renters, and umbrella.</li>\n<li>Lead product rationalization efforts, optimizing insurers’ portfolios to reduce complexity, enhance profitability, and improve customer experience.</li>\n<li>Drive new product development, leveraging telematics, usage-based insurance (UBI), embedded insurance, and AI-driven pricing models.</li>\n<li>Develop and implement product run-off strategies, ensuring compliance, financial stability, and seamless transition for policyholders.</li>\n<li>Guide insurers through regulatory advisory initiatives, ensuring product strategies align with state DOI regulations, NAIC model laws, and evolving consumer protection standards.</li>\n</ul>\n<ul>\n<li>Regulatory Compliance &amp; Market Strategy*</li>\n<li>Advise on state and federal regulations, helping clients navigate rate filings, compliance risks, and policyholder protections.</li>\n<li>Manage engagements related to state DOI rate filings, competitive benchmarking, and regulatory impact assessments.</li>\n<li>Provide insights on emerging legislative changes (e.g., climate risk mandates, AI-driven underwriting guidelines, and telematics regulations).</li>\n</ul>\n<ul>\n<li>InsurTech Enablement &amp; Digital Transformation*</li>\n<li>Partner with technology teams to implement digital underwriting, AI-based risk models, and automation tools.</li>\n<li>Evaluate and recommend InsurTech solutions such as:</li>\n<li>Telematics-based pricing (e.g., Cambridge Mobile Telematics, Arity)</li>\n<li>AI-driven claims processing (e.g., CCC Intelligent Solutions, Snapsheet)</li>\n<li>Fraud detection &amp; predictive analytics (e.g., Shift Technology, FRISS)</li>\n<li>Customer experience &amp; digital distribution (e.g., Cover Genius, Trov)</li>\n<li>Support insurers in modernizing core platforms, working with vendors like Guidewire, Duck Creek, and Majesco.</li>\n</ul>\n<ul>\n<li>Claims Transformation &amp; Risk Management*</li>\n<li>Assist clients in claims process optimization, leveraging automation, AI, and predictive analytics for faster claims adjudication.</li>\n<li>Develop strategies for fraud detection, litigation management, and claims efficiency improvements.</li>\n<li>Work with claims and risk teams to align product design with evolving risk trends (e.g., climate change impact, cyber risks in personal lines, and increased litigation costs).</li>\n</ul>\n<ul>\n<li>Project Leadership &amp; Stakeholder Engagement*</li>\n<li>Lead cross-functional consulting engagements involving actuarial, underwriting, IT, claims, and distribution teams.</li>\n<li>Develop and present strategic recommendations to C-suite executives, supporting data-driven decision-making.</li>\n<li>Manage multiple client engagements, ensuring timely delivery, regulatory alignment, and measurable business impact.</li>\n</ul>\n<p>**Requirements:*</p>\n<ul>\n<li>Education: Bachelor’s degree in Business, Finance, Insurance, or a related field (MBA, CPCU, or AINS preferred).</li>\n<li>Experience: 5+ years in P&amp;C insurance product management, consulting, or strategy roles, with a strong focus on personal lines.</li>\n<li>Industry Certifications (Preferred):</li>\n<li>CPCU (Chartered Property Casualty Underwriter) – Deep expertise in P&amp;C insurance.</li>\n<li>AINS (Associate in General Insurance) – Strong foundational knowledge of insurance operations.</li>\n<li>ARM (Associate in Risk Management) – Specialization in risk assessment and mitigation.</li>\n<li>Lean Six Sigma or PMP – For project management and operational efficiency.</li>\n<li>Technical Expertise:</li>\n<li>Deep knowledge of personal lines product development, pricing, underwriting, and risk management.</li>\n<li>Experience with product rationalization, run-off strategies, and market repositioning.</li>\n<li>Strong understanding of state insurance regulations, rate filings, and DOI compliance.</li>\n<li>Familiarity with InsurTech solutions, AI-driven pricing models, and claims automation technologies.</li>\n<li>Proficiency in data analytics tools (e.g., SQL, Python, Tableau, Power BI) for actuarial and risk modeling.</li>\n<li>Consulting &amp; Leadership Skills:</li>\n<li>Proven ability to develop strategic recommendations and present to C-suite executives.</li>\n<li>Strong project management skills with experience leading cross-functional teams in product transformation.</li>\n<li>Excellent problem-solving, analytical, and communication abilities.</li>\n<li>Expertise in Agile methodologies for product development and market deployment.</li>\n<li>Use of Lean Six Sigma frameworks for process optimization and operational efficiency.</li>\n<li>Experience with customer journey mapping, product lifecycle management, and digital transformation strategies.</li>\n</ul>\n<p><strong>Benefits:</strong></p>\n<p>This position comes with competitive compensation and benefits package:</p>\n<ol>\n<li>Competitive salary and performance-based bonuses</li>\n<li>Comprehensive benefits package</li>\n<li>Career development and training opportunities</li>\n<li>Flexible work arrangements (remote and/or office-based)</li>\n<li>Dynamic and inclusive work culture within a globally renowned group</li>\n<li>Private Health Insurance</li>\n<li>Retirement Plans</li>\n<li>Paid Time Off</li>\n<li>Training &amp; Development</li>\n</ol>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">XML job scraping automation by <a href=\"https://yubhub.co\">YubHub</a></p>","url":"https://yubhub.co/jobs/job_70e37318-27b","directApply":true,"hiringOrganization":{"@type":"Organization","name":"Capgemini","sameAs":"https://www.capgemini.com/","logo":"https://logos.yubhub.co/capgemini.com.png"},"x-apply-url":"https://jobs.workable.com/view/6BPmugRYLzEuFnsv77zoyn/hybrid-senior-p%26c-insurance-product-management-specialist-in-dallas-at-capgemini","x-work-arrangement":"hybrid","x-experience-level":"senior","x-job-type":"full-time","x-salary-range":"Competitive salary and performance-based bonuses","x-skills-required":["Product management","Insurance","Personal lines","Pricing","Underwriting","Compliance","Regulatory strategy","InsurTech","Digital transformation","Data analytics","SQL","Python","Tableau","Power BI","Agile methodologies","Lean Six Sigma","Customer journey mapping","Product lifecycle management","Digital transformation strategies"],"x-skills-preferred":["CPCU","AINS","ARM","PMP","Telematics-based pricing","AI-driven claims processing","Fraud detection & predictive analytics","Customer experience & digital distribution"],"datePosted":"2026-04-24T14:15:40.444Z","jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Dallas"}},"employmentType":"FULL_TIME","occupationalCategory":"Finance","industry":"Insurance","skills":"Product management, Insurance, Personal lines, Pricing, Underwriting, Compliance, Regulatory strategy, InsurTech, Digital transformation, Data analytics, SQL, Python, Tableau, Power BI, Agile methodologies, Lean Six Sigma, Customer journey mapping, Product lifecycle management, Digital transformation strategies, CPCU, AINS, ARM, PMP, Telematics-based pricing, AI-driven claims processing, Fraud detection & predictive analytics, Customer experience & digital distribution"},{"@context":"https://schema.org","@type":"JobPosting","identifier":{"@type":"PropertyValue","name":"YubHub","value":"job_e9935992-bf9"},"title":"Medical Director Clinical Development Neurology","description":"<p>Medical Director, Clinical Development Neurology</p>\n<p>The Medical Director, Clinical Development may lead the clinical sub-team or support the clinical sub-team and the global program team to build global clinical development plans and contributes to the development of asset level and therapeutic area strategies.</p>\n<p>Responsible for overseeing the clinical development strategy development and execution for 1 program, leading the clinical subteam to the GPT and represents clinical development on the GPT, contributing to the development of regulatory strategy, and representing the clinical program at regulatory meetings, as assigned by manager.</p>\n<p><strong>Key Responsibilities:</strong></p>\n<ul>\n<li>Lead or support the clinical subteam and oversee the design and execution of multiple clinical studies or clinical programs.</li>\n<li>Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees.</li>\n<li>Functionally, supervise and develop medical monitors and/or clinical development scientists (CDS), if any and as assigned by the manager.</li>\n<li>Lead one or more clinical study teams in the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents, as assigned by manager.</li>\n<li>Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents.</li>\n<li>Determine appropriate external experts for advisory boards, steering committees, adjudication committees, and/or data monitoring committees, and lead the team in preparation for meetings.</li>\n<li>Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans, and therapeutic area strategy.</li>\n<li>Serve as the Medical input to the Global Development Team/Subteam and the Medical Expert for clinical study team.</li>\n<li>Conduct medical monitoring activities during periods of vacations, team restructuring, team departures or in other situations, as assigned by manager.</li>\n<li>Lead the presentation of clinical trial related information/data to senior management, as assigned by manager.</li>\n<li>Liaise internally with other members of the clinical development team to drive overall program strategy and development plans. Represent Clinical Development at the Global Program Team.</li>\n<li>Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.</li>\n<li>Support business development activities, such as due diligence and research collaborations, as assigned by manager.</li>\n<li>May serve as the Translational Science lead for one or more programs, as assigned by manager.</li>\n<li>Working as part of a cross-functional team with colleagues representing biostatistics, data management, clinical pharmacology, commercial, regulatory, safety, quality, and project management, or others, as assigned by manager.</li>\n</ul>\n<p><strong>Requirements:</strong></p>\n<ul>\n<li>Physician with MD or foreign equivalent.</li>\n<li>3-5 years of clinical development experience preferably within industry.</li>\n<li>3-5 years minimum experience as a medical monitor for clinical trials required.</li>\n<li>Regulatory experience preferred.</li>\n<li>Track record of publication in peer-reviewed journals, preferably first-authored publications.</li>\n<li>Excellent written/oral communication skills.</li>\n<li>Attention to detail and ability to think strategically.</li>\n<li>Willingness to take on new responsibilities.</li>\n<li>Interest and ability to learn about new therapeutic areas.</li>\n</ul>\n<p><strong>Preferred Qualifications:</strong></p>\n<ul>\n<li>Clinical specialty certification from US or foreign equivalent.</li>\n<li>Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss, and represent trial or program level data.</li>\n<li>3+ years of industry experience in clinical development is preferred.</li>\n<li>Experience for medical responsibilities on a cross-functional team preferred.</li>\n<li>Formal training (certificate or graduate degree) in epidemiology, clinical trials, clinical research, biostatistics is strongly preferred.</li>\n<li>Broad experience in the principles of clinical trial methodology, statistics, data analysis, and interpretation.</li>\n<li>Understanding of general (and specific) therapeutic principles.</li>\n<li>Experience designing and executing industry-sponsored clinical trials.</li>\n<li>Expert in scientific literature searches and weighing of quality peer-reviewed data.</li>\n<li>Experience authoring study essential documents, Clinical Study Reports, and regulatory documents.</li>\n<li>Strong relevant therapeutic area experience.</li>\n<li>Ability to clearly communicate to internal and external stakeholders orally and in writing.</li>\n<li>Experience interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.</li>\n<li>Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company&#39;s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results.</li>\n<li>Ability to prioritize multiple tasks and goals to ensure completion in a timely manner within budget.</li>\n<li>Ability to think both strategically and tactically.</li>\n<li>Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss, and represent trial or program level data.</li>\n</ul>\n<p><strong>Working at Alexion:</strong></p>\n<p>We&#39;re inspired to think differently, to create better outcomes. By creating an unparalleled employee experience, our organization is equipped to adapt and enrich employees with a productive, engaging, and enjoyable work experience, while accelerating world-class leadership and innovation capabilities that can deliver on our mission.</p>\n<p>Each of us is accountable for delivering innovative medicines and supportive technology with integrity so we can truly understand and better the lives of people affected by rare diseases. Together, we can transform lives every day.</p>\n<p><strong>The Highest Standards:</strong></p>\n<p>By operating with the highest standards of ethics and integrity, we aspire to live up to the expectations of patients, physicians, and ourselves, and to earn trust in our communities.</p>\n<p><strong>Diversity:</strong></p>\n<p>We encourage diversity of backgrounds and ideas. We genuinely care for and respect each other, working together as a high-performing team to deliver extraordinary results while embracing different perspectives.</p>\n<p><strong>Dedication:</strong></p>\n<p>The dedication and passion of our employees enable us to stay focused on what matters most. We push ourselves to achieve the highest level of medical innovation, and to redefine what it means to live with a rare disease.</p>\n<p>In-Office Hybrid:</p>\n<p>This role has an expectation of working in the office a minimum of 3 days a week. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working</p>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">XML job scraping automation by <a href=\"https://yubhub.co\">YubHub</a></p>","url":"https://yubhub.co/jobs/job_e9935992-bf9","directApply":true,"hiringOrganization":{"@type":"Organization","name":"Clinical Development – Neurology & Genomic Medicine","sameAs":"https://astrazeneca.eightfold.ai","logo":"https://logos.yubhub.co/astrazeneca.eightfold.ai.png"},"x-apply-url":"https://astrazeneca.eightfold.ai/careers/job/563877689959090","x-work-arrangement":"hybrid","x-experience-level":null,"x-job-type":null,"x-salary-range":null,"x-skills-required":["Clinical Development","Neurology","Genomic Medicine","Regulatory Strategy","Clinical Trials","Medical Research","Scientific Literature","Peer-Reviewed Journals","Clinical Study Reports","Regulatory Documents","Translational Science","Biostatistics","Data Management","Clinical Pharmacology","Commercial Operations","Regulatory Affairs","Safety and Quality","Project 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for leading the development and implementation of the regional or global regulatory strategy for a CGT product/group of products.</p>\n<p>Ensures that the strategy is designed for efficient development tailored to the global or specific regional regulatory environment(s), and to deliver approvals aligned to the needs of the business, markets and patients.</p>\n<p>This includes optimising the health authority engagement strategy, aligning cross-functionally on messaging, planning the development of submission documents, and driving designation of applicable expedited regulatory programs such as FastTrack, RMAT, Breakthrough, and PRIME.</p>\n<p>Lead cross-functional teams in major regulatory submissions (NDA, IND/CTA), Health Authority interactions, label negotiations, and securing NDA/BLA approvals.</p>\n<p>This includes developing the strategy, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself.</p>\n<p>Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling, and members of the submission and execution team in formulating global regulatory strategy and delivering on NDA filings and approvals</p>\n<p>As a regional regulatory lead, the RAD is accountable for providing the region-specific regulatory strategy and direction.</p>\n<p>May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice and be accountable for all Regulatory activities</p>\n<p>Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations.</p>\n<p>Lead preparation of the regulatory strategy document and target product labeling.</p>\n<p>Demonstrate strategic leadership skills contributing to product development.</p>\n<p>Provide team leadership in a matrixed environment and participate in coaching, and performance feedback to members of the GRST.</p>\n<p>Lead the objective assessment of emerging data and regulatory environments against aspirations and update senior management on project risks/mitigation activities.</p>\n<p>Ensure appropriate planning and construction of the global dossier and core prescribing information led by the respective teams.</p>\n<p>Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.</p>\n<p>Essential for the role:</p>\n<p>Bachelor&#39;s degree in a science related field and/or other appropriate knowledge/experience.</p>\n<p>At least 5 years&#39; experience in regulatory drug development or equivalent with a focus on cell and gene therapy products for malignant diseases.</p>\n<p>Experience with major Health Authority interactions including direct engagements with US FDA/CBER.</p>\n<p>Hands-on leadership of IND and pre-IND CGT programs.</p>\n<p>A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.</p>\n<p>Demonstrated competencies of strategic thinking, influencing, innovation, initiative, leadership and excellent oral and written communication skills.</p>\n<p>Desirable for the role:</p>\n<p>Scientific background in area relevant to oncology cell and gene therapy development.</p>\n<p>Understanding of non-clinical and CMC regulatory principles pertaining to CGT, including comparability and potency.</p>\n<p>A solid grasp of guiding principles in drug development.</p>\n<p>This includes benefit/risk profile, dose selection, and statistical development related to cell and gene therapy products.</p>\n<p>It also involves using small datasets to support Health Authority alignment.</p>\n<p>Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.</p>\n<p>Contribution to a regulatory approval including leading response team and labeling negotiations</p>\n<p>Ability to work strategically within a complex, business-critical and high-profile development program.</p>\n<p>Critical thinking on current global regulatory science and policy pertaining to CGT, and good understanding of the corresponding scientific and clinical components.</p>\n<p>Prior experience with phase 3 design including end of phase 2 health authority interactions</p>\n<p>Office Working Requirements</p>\n<p>When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.</p>\n<p>In-person working gives us the platform we need to connect, work at pace and challenge perceptions.</p>\n<p>That’s why we work, on average, a minimum of three days per week from the office.</p>\n<p>But that doesn’t mean we’re not flexible.</p>\n<p>We balance the expectation of being in the office while respecting individual flexibility.</p>\n<p>Join us in our unique and ambitious world.</p>\n<p>The annual base pay for this position ranges from $178,534.40 - 267,801.60 USD.</p>\n<p>Our positions offer eligibility for various incentives,an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.</p>\n<p>Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.</p>\n<p>#LI-Hybrid</p>\n<p>Date Posted 20-Apr-2026</p>\n<p>Closing Date 03-May-2026</p>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">XML job scraping automation by <a href=\"https://yubhub.co\">YubHub</a></p>","url":"https://yubhub.co/jobs/job_ba7f93c3-717","directApply":true,"hiringOrganization":{"@type":"Organization","name":"ONC Reg Portfolio 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This role sits at the heart of that mission, combining scientific depth with strategic leadership to advance care in chronic respiratory disease. As US Head of Medical, COPD, this position owns the medical strategy and execution for a novel Interleukin-33 targeting monoclonal antibody, crafting both product and disease area direction across the full lifecycle. Reporting directly to the VP Medical Respiratory, Immunology, Vaccines and Immune Therapies (R&amp;I), this leader will guide a high-performing team, drive launches, and influence how evidence, access and clinical practice come together to transform outcomes for patients living with COPD and severe lower respiratory tract disease. Ready to steer a first-in-class biologic and redefine what’s possible in respiratory medicine?</p>\n<p><strong>Accountabilities</strong></p>\n<ul>\n<li>Lead and grow the COPD US medical team, setting clear vision, priorities and standards for excellence in disease area and brand strategy and execution.</li>\n<li>Develop and deliver coordinated medical strategies and plans for COPD and related indications, ensuring alignment with global medical, US commercial and market access partners.</li>\n<li>Develop and implement Transforming Healthcare initiatives that shape the biologics market in COPD, severe LRTD and adjacent areas, using evidence and insight to influence clinical practice and care pathways.</li>\n<li>Own disease area and brand medical budgets and resource planning, ensuring optimal allocation to high-impact activities across the lifecycle.</li>\n<li>Co-lead the COPD Core Value Team with Commercial and Market Access leaders, connecting strategy, science, access and execution to deliver a cohesive launch plan.</li>\n<li>Continuously assess and communicate the competitive landscape, translating insights into differentiated positioning and tactical plans.</li>\n<li>Act as the primary US medical point of contact for the Global Product Team (GPT), providing strategic input on lifecycle management, phase IV strategy and study design.</li>\n<li>Partner with evidence generation teams to define and execute real-world evidence programs that address US clinical, payer and policy needs.</li>\n<li>Build and sustain positive relationships with external authorities, professional societies, patient groups and key internal stakeholders to inform strategy and amplify scientific leadership.</li>\n<li>Serve as a medical spokesperson for COPD in response to media inquiries when required, ensuring accurate, balanced and compliant communication.</li>\n<li>Coach, mentor and develop direct reports, actively leading succession, talent development and engagement within the team.</li>\n<li>Nurture a culture that values scientific rigor, teamwork, innovation and recognition, while maintaining full compliance with AstraZeneca policies and external regulations.</li>\n</ul>\n<p><strong>Essential Skills/Experience</strong></p>\n<ul>\n<li>Sophisticated Scientific Degree (MBBS, PharmD, PhD, or MD) or equivalent education</li>\n<li>A Minimum of 7 years of experience in the pharmaceutical industry, ideally in Medical Affairs, working at the country and global/regional level</li>\n<li>Medical/clinical/scientific expertise in Respiratory Disease</li>\n<li>Experienced team leader, with a track record of establishing high performance teams</li>\n<li>Demonstrated track record delivering results in a sophisticated matrix environment, building capabilities, and leading impactful medical initiatives. Experience launching a new product</li>\n<li>US Regulatory Strategy Knowledge including product approval, label requirements/ negotiation</li>\n<li>Consistent track record to collaborate and build internal and external networks</li>\n<li>Strong intuition for business, with comprehensive understanding of the U.S. healthcare environment</li>\n</ul>\n<p><strong>Desirable Skills/Experience</strong></p>\n<ul>\n<li>Leadership experience in US Medical Affairs for respiratory biologics or other specialty therapeutics.</li>\n<li>Direct involvement in major US product launches in COPD or related respiratory indications.</li>\n<li>Experience crafting or overseeing real-world evidence programs passionate about payer needs and healthcare system impact.</li>\n<li>Background working closely with field medical teams and external authorities to develop standards of care.</li>\n<li>Track record influencing cross-functional investment decisions using medical insights and data.</li>\n</ul>\n<p>When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That&#39;s why we work, on average, a minimum of three days per week from the office. But that doesn&#39;t mean we&#39;re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.</p>\n<p>AstraZeneca offers an environment where medical leaders sit at the intersection of science and real-world practice, using evidence to influence how care is delivered today and tomorrow. Work alongside experts who embrace change because it sparks innovation, from bold real-world studies to pioneering launches that shift treatment paradigms in respiratory disease. Collaboration across research, medical and commercial functions is embedded in how things get done here, opening doors to new ideas, broader networks and continuous development without borders. Every study designed, every partnership built and every insight translated into practice contributes directly to better outcomes for patients and fuels the next wave of scientific progress.</p>\n<p>If this opportunity to lead COPD medical strategy in the US excites you, apply now and take the next step in your career with AstraZeneca.</p>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">XML job scraping automation by <a href=\"https://yubhub.co\">YubHub</a></p>","url":"https://yubhub.co/jobs/job_da3b6069-504","directApply":true,"hiringOrganization":{"@type":"Organization","name":"Respiratory Medical","sameAs":"https://astrazeneca.eightfold.ai","logo":"https://logos.yubhub.co/astrazeneca.eightfold.ai.png"},"x-apply-url":"https://astrazeneca.eightfold.ai/careers/job/563877689854061","x-work-arrangement":"hybrid","x-experience-level":"senior","x-job-type":"full-time","x-salary-range":null,"x-skills-required":["Sophisticated Scientific Degree","Minimum of 7 years of experience in the pharmaceutical industry","Medical/clinical/scientific expertise in Respiratory Disease","Experienced team leader","Demonstrated track record delivering results in a sophisticated matrix environment","US Regulatory Strategy Knowledge","Strong intuition for business"],"x-skills-preferred":["Leadership experience in US Medical Affairs","Direct involvement in major US product launches","Experience crafting or overseeing real-world evidence programs","Background working closely with field medical teams and external authorities","Track record influencing cross-functional investment decisions"],"datePosted":"2026-04-18T22:13:59.674Z","jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Wilmington, Delaware, United States of America"}},"employmentType":"FULL_TIME","occupationalCategory":"Medical","industry":"Pharmaceuticals","skills":"Sophisticated Scientific Degree, Minimum of 7 years of experience in the pharmaceutical industry, Medical/clinical/scientific expertise in Respiratory Disease, Experienced team leader, Demonstrated track record delivering results in a sophisticated matrix environment, US Regulatory Strategy Knowledge, Strong intuition for business, Leadership experience in US Medical Affairs, Direct involvement in major US product launches, Experience crafting or overseeing real-world evidence programs, Background working closely with field medical teams and external authorities, Track record influencing cross-functional investment decisions"}]}