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Responsibilities generally commence post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management.</p>\n<p><strong>Key Responsibilities:</strong></p>\n<ul>\n<li>Contribute to the design of efficient clinical development programs and robust registration packages as a member of a multi-disciplinary team.</li>\n<li>Play a central role in predicting human dose range, characterizing exposure-response relationship, and justifying dose recommendations for later studies and for special populations.</li>\n<li>Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics.</li>\n<li>Develop mathematical models to understand disease, its progression, and drug pharmacodynamics and pharmacokinetics.</li>\n<li>Present the CPMS strategy and discuss outcome of model-based approaches via interactions with project teams, governance boards, and regulatory agencies.</li>\n<li>Write sections of drug development and registration documents such as clinical trial protocols and reports.</li>\n<li>Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy.</li>\n<li>Advocate for the use of model-informed drug discovery and development (MID3) in teams and through external collaboration.</li>\n</ul>\n<p><strong>Basic Qualifications:</strong></p>\n<ul>\n<li>Advanced training with a PhD or MD in Pharmaceutical Sciences, (Bio)Engineering, Statistics, Medicine, or related field.</li>\n<li>5+ years&#39; experience leveraging clinical pharmacology and modeling in drug development.</li>\n<li>5+ years&#39; experience applying pharmacokinetic and pharmacodynamic principles and commonly applied pharmacometric models.</li>\n<li>5+ years of experience utilizing tools for quantitative clinical pharmacology such as NONMEM, Monolix, or R.</li>\n</ul>\n<p><strong>Preferred Qualifications:</strong></p>\n<ul>\n<li>Oncology drug development experience.</li>\n<li>Solid experience with advanced pharmacometric approaches.</li>\n<li>Experience in designing, analyzing, and reporting clinical studies.</li>\n<li>Familiarity with M&amp;S contributions to regulatory interaction and submission documents.</li>\n</ul>\n<p><strong>Benefits:</strong></p>\n<ul>\n<li>Health care and other insurance benefits (for employee and family).</li>\n<li>Retirement benefits.</li>\n<li>Paid holidays.</li>\n<li>Vacation.</li>\n<li>Paid caregiver/parental and medical leave.</li>\n</ul>\n<p><strong>Salary:</strong></p>\n<ul>\n<li>$188,100 to $313,500 per year (for US locations)</li>\n</ul>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">Job Data by <a href=\"https://yubhub.co\">YubHub</a>.</p>","url":"https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Upper-Providence/Director--Oncology-Clinical-Pharmacology-Modeling---Simulation_450627","directApply":true,"hiringOrganization":{"@type":"Organization","name":"GSK","sameAs":"https://www.gsk.com","logo":"https://logos.yubhub.co/gsk.com.png"},"x-apply-url":"https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Upper-Providence/Director--Oncology-Clinical-Pharmacology-Modeling---Simulation_450627","x-work-arrangement":"hybrid","x-experience-level":"senior","x-job-type":"full-time","x-salary-range":"$188,100 to $313,500","x-skills-required":["Drug Design","Drug Development","Pharmaceutical Sciences","Pharmacodynamics","Pharmacokinetics","Pharmacology","Pharmacometrics"],"x-skills-preferred":["Oncology drug development","Advanced pharmacometric approaches","Model-based meta-analysis","Adaptive dosing simulations","Mechanistic PKPD modeling"],"x-benefits":["pension","paid_leave","bonus"],"x-licences":[],"x-visa-sponsorship":"unknown","x-visa-sponsorship-text":null,"x-work-authorisation":"unknown","x-work-authorisation-text":null,"datePosted":"2026-10-28T00:00:00.000Z","jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Pennsylvania - Upper Providence"}},"employmentType":"FULL_TIME","occupationalCategory":"Healthcare","industry":"Healthcare","skills":"Drug Design, Drug Development, Pharmaceutical Sciences, Pharmacodynamics, Pharmacokinetics, Pharmacology, Pharmacometrics, Oncology drug development, Advanced pharmacometric approaches, Model-based meta-analysis, Adaptive dosing simulations, Mechanistic PKPD modeling","baseSalary":{"@type":"MonetaryAmount","currency":"USD","value":{"@type":"QuantitativeValue","minValue":188100,"maxValue":313500,"unitText":"YEAR"}}},{"@context":"https://schema.org","@type":"JobPosting","identifier":{"@type":"PropertyValue","name":"YubHub","value":"job_1ad7bba0-665"},"title":"Regulatory Affairs Manager, CMC mRNA Vx Development Products","description":"<p>As a Regulatory Affairs Manager in Chemistry, Manufacturing, and Controls (CMC) for mRNA-based vaccine development products, you will lead key regulatory activities that guide products from late-stage development through early lifecycle management.</p>\n<p>In close partnership and collaboration with cross-functional teams including regulatory, manufacturing, quality, and development, you will help shape regulatory CMC strategies that ensure compliance and timely approvals.</p>\n<p>Responsibilities:</p>\n<ul>\n<li>Development and execution of CMC (Module 3/2.3) regulatory strategies for vaccine products, ensuring alignment with U.S. regulatory expectations and global requirements (mainly Europe and Japan), including health authority interactions</li>\n<li>Prepare, review, and check CMC documentation for regulatory submissions (IND/CTA, BLA/MAA/JNDA and early life cycle variations) and consultations to meet regulatory compliance and quality standards.</li>\n<li>Collaborate with and provide timely regulatory advice to cross-functional CMC workstreams and matrix teams including manufacturing and quality to support RA CMC strategy development and flawless execution</li>\n<li>Contribute to planning and tracking of CMC source documents and dossier sections to ensure Right-First-Time submission readiness.</li>\n<li>Identify regulatory risks and propose mitigation plans to ensure smooth project progress and successful submissions.</li>\n<li>Support team members, fostering continuous improvement and sharing best practices in CMC regulatory affairs.</li>\n</ul>\n<p>Basic Qualifications &amp; Skills:</p>\n<ul>\n<li>A minimum of a Bachelor’s degree in life sciences, pharmacy, chemistry, biotechnology, or a related scientific discipline.</li>\n<li>Minimum of 2 years of experience in CMC regulatory affairs, with exposure to vaccine or biologics development and regulatory submissions.</li>\n<li>Minimum of 1 year of experience preparing or contributing to CMC sections of regulatory submissions in the US and EU markets for biologicals and/or vaccines.</li>\n</ul>\n<p>Preferred Qualifications &amp; Skills:</p>\n<ul>\n<li>Advanced degree (Master’s or PhD) in a scientific or regulatory field.</li>\n<li>Knowledge of U.S. and global regulatory requirements including FDA regulations, Good Manufacturing Practices (GMP), and guideline standards (e.g. ICH) for biologicals/vaccines.</li>\n<li>Experience working collaboratively within cross-functional teams across regulatory, manufacturing, quality, and development functions.</li>\n<li>Good awareness of AI tools and eagerness to apply them responsibly to increase efficiency and/or quality of RA deliverables.</li>\n<li>Experience with the preparation of regulatory interactions and negotiations including FDA meetings (e.g. Type C or pre-BLA), CHMP Scientific advice and /or PMDA consultations.</li>\n<li>Proven ability to develop and implement CMC strategies for complex vaccine or biologics products while managing multiple priorities and deadlines in a dynamic environment.</li>\n<li>Familiarity with electronic submission formats and systems (e.g. Veeva)</li>\n<li>Experience supporting regulatory inspections and providing input on manufacturing or process changes.</li>\n</ul>\n<p>Benefits:</p>\n<ul>\n<li>Competitive salary</li>\n<li>Annual bonus based on company performance</li>\n<li>Healthcare and wellbeing programs</li>\n<li>Pension plan membership</li>\n<li>Shares and savings programme</li>\n<li>Performance with Choice programme offering remote or hybrid working model</li>\n</ul>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">Job Data by <a href=\"https://yubhub.co\">YubHub</a>.</p>","url":"https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Upper-Providence/Regulatory-Affairs-Manager--CMC-mRNA-Vx-Development-Products_450407-1","directApply":true,"hiringOrganization":{"@type":"Organization","name":"GSK","sameAs":"https://www.gsk.com","logo":"https://logos.yubhub.co/gsk.com.png"},"x-apply-url":"https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Upper-Providence/Regulatory-Affairs-Manager--CMC-mRNA-Vx-Development-Products_450407-1","x-work-arrangement":"hybrid","x-experience-level":"senior","x-job-type":"full-time","x-salary-range":"$113,850 to $189,750","x-skills-required":["Communication","Digital Fluency","Influencing Without Authority","Learning Agility","Pharmaceutical Regulatory Compliance","Problem Solving","Regulatory Strategies","Strategic Leadership"],"x-skills-preferred":["Advanced degree in scientific or regulatory field","Knowledge of FDA regulations","Experience with AI tools","Familiarity with electronic submission formats"],"x-benefits":["pension","paid_leave","bonus"],"x-licences":[],"x-visa-sponsorship":"unknown","x-visa-sponsorship-text":null,"x-work-authorisation":"unknown","x-work-authorisation-text":null,"datePosted":"2026-10-29T00:00:00.000Z","jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Pennsylvania - Upper Providence"}},"employmentType":"FULL_TIME","occupationalCategory":"Healthcare","industry":"Healthcare","skills":"Communication, Digital Fluency, Influencing Without Authority, Learning Agility, Pharmaceutical Regulatory Compliance, Problem Solving, Regulatory Strategies, Strategic Leadership, Advanced degree in scientific or regulatory field, Knowledge of FDA regulations, Experience with AI tools, Familiarity with electronic submission formats","baseSalary":{"@type":"MonetaryAmount","currency":"USD","value":{"@type":"QuantitativeValue","minValue":113850,"maxValue":189750,"unitText":"YEAR"}}},{"@context":"https://schema.org","@type":"JobPosting","identifier":{"@type":"PropertyValue","name":"YubHub","value":"job_8efbafb3-7f5"},"title":"Associate Director","description":"<p>At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&amp;D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives.</p>\n<p>The Associate Director is a global role responsible for driving strategic initiatives for value delivery. The role applies advance biostatistical methods and AI tools to real world data (RWD), in order to generate real world evidence (RWE) for informing trial design, regulatory submissions, reimbursement and safety signals.</p>\n<p><strong>Responsibilities:</strong></p>\n<ul>\n<li><strong>Biostatistics:</strong></li>\n</ul>\n<p>+ Lead the design and analysis of non-interventional studies, aligning with cross functional teams, managing timelines, and ensuring methodological rigor and quality control.   + Apply statistical and RWD expertise to guide the selection and appropriate use of complex health data sets, co-develop variable definitions, code lists, and author technical specification documents.   + Develop and refine statistical analysis plans, conduct complex statistical analyses, including causal inference, comparative effectiveness, target trial emulation, and communicate findings to internal and external stakeholders.</p>\n<ul>\n<li><strong>Strategic Initiatives:</strong></li>\n</ul>\n<p>+ Serve as a senior-level RWB consultant within matrix teams, leveraging in-depth expertise on assigned assets.   + Serve on enterprise level strategic initiatives, for example Disease Area Acceleration Teams, for organizational deliverables.</p>\n<ul>\n<li><strong>Communication:</strong></li>\n</ul>\n<p>+ Present statistical analyses and insights effectively to internal stakeholders and external audiences, including conferences and publications, showcasing the value of biostatistical contributions.   + Engage in strategic communication to reinforce the role of biostatistics in driving innovation and decision-making across the organization.</p>\n<ul>\n<li><strong>Methodological Development and Innovation:</strong></li>\n</ul>\n<p>+ Stay informed on emerging industry trends and incorporate cutting-edge biostatistical methods to improve study designs and analytics.   + Conduct methodological research and contribute to the development/application of new analytical techniques.</p>\n<ul>\n<li><strong>Regulatory Support and Compliance:</strong></li>\n</ul>\n<p>+ Provide biostatistical expertise on RWD during regulatory submissions, preparing for meetings and addressing regulatory queries to ensure compliance with industry standards.   + Stay current with regulatory guidance on the use of RWD for decision-making and advise on statistical approaches aligned with regulatory expectations.</p>\n<p><strong>Requirements:</strong></p>\n<ul>\n<li>Ph.D. in Statistics, Data Science, Epidemiology, or related field with 6+ years of experience (or Master’s degree with 8+ years) in the pharmaceutical/biotech industry, preferably in real-world evidence, epidemiology, or health outcomes research.</li>\n<li>Experience with drug development processes, with demonstrated ability to apply innovative statistical thinking to achieve project and business objectives.</li>\n<li>Experience using RWD (e.g., electronic health records, insurance claims, registries) and applying observational study designs and biostatistical principles in clinical/epidemiological research.</li>\n<li>Experience with programming languages R and SQL, with applied experience working with observational datasets.</li>\n</ul>\n<p><strong>Benefits:</strong>   + Comprehensive benefits program, please visit GSK US Benefits Summary to learn more.</p>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">Job Data by <a href=\"https://yubhub.co\">YubHub</a>.</p>","url":"https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Upper-Providence/Associate-Director--Real-World-Biostatistics_447563","directApply":true,"hiringOrganization":{"@type":"Organization","name":"GSK","sameAs":"https://www.gsk.com","logo":"https://logos.yubhub.co/gsk.com.png"},"x-apply-url":"https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Upper-Providence/Associate-Director--Real-World-Biostatistics_447563","x-work-arrangement":null,"x-experience-level":"senior","x-job-type":"full-time","x-salary-range":null,"x-skills-required":["Statistics","Data Science","Epidemiology","R","SQL"],"x-skills-preferred":["Machine Learning","Causal Inference","Comparative Effectiveness","Time to Event Analysis","Longitudinal Modelling","Predictive Modelling","External Control Arms"],"x-benefits":[],"x-licences":[],"x-visa-sponsorship":"unknown","x-visa-sponsorship-text":null,"x-work-authorisation":"unknown","x-work-authorisation-text":null,"datePosted":"2026-10-15T00:00:00.000Z","jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Pennsylvania - Upper Providence"}},"employmentType":"FULL_TIME","occupationalCategory":"Data Science","industry":"Healthcare","skills":"Statistics, Data Science, Epidemiology, R, SQL, Machine Learning, Causal Inference, Comparative Effectiveness, Time to Event Analysis, Longitudinal Modelling, Predictive Modelling, External Control Arms"}]}