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The Role Every clinical trial depends on a commitment to the people who take part: their rights, safety and wellbeing come first, and the data they help generate can be trusted. Once a product reaches patients, that commitment continues through the monitoring of its safety and benefit-risk. This role holds the organisation to both. As Head of Patient-Facing Quality Assurance, you will lead an integrated QA organisation covering Good Clinical Practice and Good Pharmacovigilance Practice, reporting to the Head of Global R&D Quality. Your team will include PV System and Process Leads, Therapeutic Area Quality Leads, and a Head of Clinical QA or of PV and Regulatory QA, depending on which complements your own background. Hybrid (3 days a week on site), based in Maidenhead, UK, or King of Prussia, PA, with other global locations open to discussion Why it matters Bringing clinical and pharmacovigilance quality under one leader is a deliberate choice. Some of the most consequential risks sit at the interfaces between them: serious adverse event reconciliation, expedited reporting, and the safety information that reaches investigators and regulators. A single function can see these clearly and act on them. The role is also a chance to shape how quality is done, not just police it. With ICH E6(R3) moving the industry toward Quality by Design and risk-based quality management, you will set the strategy, operating model and standards for how the company protects participants and patients. You will keep the specialist depth that GCP and GVP each need while making the approach consistent worldwide. What You’ll Be Responsible For You will provide independent, risk-based QA oversight from trial design through close-out, and across the global pharmacovigilance system. You will be the consistent quality voice in governance and a constructive challenger to the functions that own operational delivery. • Setting the strategy, operating model, governance, capabilities and global resource model for Clinical QA and PV QA, harmonising approaches without diluting specialist expertise, • Embedding Quality by Design, critical-to-quality factors and risk-based quality management, and making sure risks to participant safety, patient safety and data integrity are escalated in time, • Assuring the quality systems behind clinical development and pharmacovigilance, including their integration with the enterprise QMS and accurate representation in the Pharmacovigilance System Master File, • Overseeing the clinical safety interfaces: SAE collection and reconciliation, SUSAR and expedited reporting, investigator safety reporting, safety data exchange agreements and signal escalation, • Running a globally consistent framework for significant quality issues, serious breaches, critical deviations and CAPAs, backed by rigorous root-cause analysis and reportability assessment, • Leading GCP and GVP inspection readiness and health-authority inspections, owning the patient-facing audit plan, and giving senior leadership an integrated view of quality risk, trends and regulatory intelligence Experience Required • At least 10 years of progressively responsible experience in pharma, biotech or regulated life sciences, with a degree in life sciences, pharmacy, medicine, nursing or a related discipline (an advanced degree or professional certification in Quality, GCP, GVP or auditing is an advantage), • Significant QA leadership in clinical quality, PV quality or both, including leading global teams in a complex matrix; experience across both GCP and GVP is strongly preferred, • Expert knowledge of GCP and GVP regulation and inspection expectations, including ICH E6(R3) and the EU GVP framework, • A track record with health-authority inspections, serious breaches, investigations, CAPAs and inspection remediation, • Hands-on experience of Quality by Design, risk-based quality management, quality metrics, data integrity and computerised systems, as well as oversight of CROs, vendors, affiliates and partners, • Experience managing budgets, consultants, workforce plans and talent, and building a team of trusted strategic advisers Note on travel This is a global role. Expect some out-of-hours meetings across time zones and periodic international travel.

CSL Seqirus is seeking a Head of Patient-Facing Quality Assurance to lead an integrated QA organisation spanning GCP and GVP, reporting to the Head of Global R&D Quality. The role is hybrid (3 days on site) based in Maidenhead, UK, or King of Prussia, PA, with other locations open to discussion. You will drive Quality by Design, risk-based quality management and data integrity across clinical development and pharmacovigilance, while maintaining expert depth in GCP and GVP and coordinating with #J-18808-Ljbffr

At CSL, patient safety is at the heart of everything we do. We're seeking a Senior Pharmacovigilance Scientist to join our Global Safety & Pharmacovigilance team, where you'll play a critical role in monitoring, evaluating, and managing the safety profile of our products across their entire lifecycle. Working closely with cross-functional global teams, you'll contribute to safety surveillance activities, signal detection, risk management, and regulatory reporting that help ensure the safe and effective use of CSL medicines worldwide. Reporting to the Vaccine Safety Science Lead. As a Senior Pharmacovigilance Scientist, you will support the ongoing assessment of clinical and post-marketing safety data, providing scientific expertise to inform benefit-risk evaluations and regulatory decision-making. You'll collaborate with Global Safety Leads and stakeholders across Development, Medical Affairs, Regulatory Affairs, and Clinical teams to support product safety strategies and risk management activities. • Lead the safety review process and evaluation of safety data throughout the product lifecycle using a combination of quantitative and qualitative approaches, in partnership with the Global Safety Lead (GSL), • Perform end to end signal detection and analysis activities on safety data sets from various sources, and present summaries of the data in a meaningful way, • Review publications from the scientific and medical literature for important safety information for further use in various analyses or aggregate safety reports (ASRs), • Provide strategic input and/or contributions to various ASRs (Periodic Safety Update Reports, Development Safety Update Reports, PADERs, Risk Management Plans etc.), • Organize and provide key insight to internal cross functional Safety Management Teams (SMTs), • Support product development teams (such as the Study Execution Team and the Clinical Development Teams) with PV related expertise relating to clinical data, • Develop response strategy and perform required analyses for any safety-related questions from internal sources and/or external regulatory requests, • Mentor more junior members of the PVS community, including assisting with on-boarding and providing advice on day-to-day tasks, • Other Activities as required, including but not limited to: case adjudication, review of key clinical documents (IBs, CSRs, etc), support in SOP updates, subject matter expert support for dedicated PVS activities, etc. You are a scientifically minded pharmacovigilance professional with strong analytical skills and a passion for patient safety. You thrive in a collaborative environment, enjoy solving complex problems, and can confidently communicate scientific information to a variety of stakeholders. • Bachelor’s or equivalent degree (depending on national educational system) required in the pharmaceutical, nursing or biological, or sciences. Degree in Medicine and Pharmacy is preferred, • 7+ years' Pharmacovigilance experience in multinational pharmaceutical industry with at least 3 years’ experience as a Pharmacovigilance scientist or equivalent position in a closely related discipline, • Understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines, and standards, • Ability to provide solutions for issues/challenges that may arise during the course of a project, • Knowledge and experience of safety monitoring and signal detection preferred, • Understanding of ICH GCP and drug development preferred, • Computer proficiency in basic database entry and graphics presentations (e.g.,Microsoft Excel or equivalent), • Excellent written and verbal communication skills in English, with the ability to evaluate, interpret and synthesize scientific data, • Self-motivated, able to prioritize and plan effectively, • Ability to work independently and as a team player, working in a cross functional environment Closing date for Applications: Friday 13th November This position is ideally based in Melbourne Australia; however, suitably qualified candidates in Zurich Switzerland, Maidenhead UK and King of Prussia are encouraged to apply. #J-18808-Ljbffr

The Global Clinical Program Leader (GCPL) is a critical role within Clinical Development. The GCPL is accountable for the design and execution of the clinical strategy to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP). The GCPL is accountable for the strategic leadership of the Clinical Development Team (CDT) in a matrix environment and is responsible for: • the timely development and execution of the Clinical Development Plan (CDP)., • managing the day-to-day operations of the CDT including but not limited to meeting coordination and documentation, decision making, and stakeholder management., • ensuring that the program is conducted in alignment with CSL Behring processes and abiding by GCP and ICH regulations. This position is accountable for the clinical & scientific oversight of the assigned program(s) and: • ensures high quality clinical & scientific standards are met during all aspects of the program, • providing clinical oversight and expertise during development of clinical studies, • serves as medical monitor for assigned clinical trials or provides oversight to an assigned medical monitor, • serves as the Clinical Development representative on the Project Strategy Team (PST), • serves as the Clinical Development representative, or provides oversight to an assigned representative to cross-functional delivery teams (eg, Study Execution Team, etc.), • undefinedThis position is a “Lead Author” or “Contributing Author” for:key study documents, including but not limited to the Clinical Development Plan (CDP), the Project Strategy Document (PSD), Investigator Brochures (IB), Clinical Study Protocols (CSP), Informed Consent Forms (ICF), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR).the clinical sections of relevant regulatory packages (e.g. IND, NDA, annual reports) and support regulatory RFIs as needed.the development of abstracts, presentations, and manuscripts as appropriate. The incumbent may also be assigned as a Business Development (BD) Contributor, or a Clinical Study Lead as appropriate for projects as assigned per business need., • Provides leadership and guidance to all members of the cross-functional CDT acting as the lead scientific expert for the clinical program, while ensuring appropriate functional representation in team discussions., • Is accountable for the timely development and maintenance of the Clinical Development Plan (CDP) in alignment with the Program Strategy Team (PST) and Therapeutic Area Leadership Team (TALT)., • Leads the integration of internal and external expert contributions to strategy and design of the assigned clinical program(s)., • Responsible for maintaining alignment across critical stakeholders prior to key decision making forums (e.g. Strategic Development Committee (SDC) or Scientific and Technical Review Committee (STRC) for study outline approval)., • Ensures that the program is conducted in alignment with CSL Behring processes and abiding by GCP and ICH regulations., • Responsible for driving and documenting decision making within the CDT, facilitating issue resolution and escalation, as well as contingency planning., • Accountable for the clinical content for all CDT deliverables to ensure safe, efficient, timely and quality execution of assigned clinical programs., • Ensures high quality clinical and scientific standards are met throughout all aspects of the program., • Serves as the clinical development representative on the required cross-functional teams, including but not limited to the Study Execution Team (SET), Safety Management Team (SMT), the Benefit-Risk Assessment Team (BRAT), the Biomarker Expert Team (BET), and the Evidence and Access Strategy Team (EAST) for assigned programs., • Develops and executes the Medical Monitoring Plan (MMP) strategy. Typically serves as the medical monitor for clinical trials during study conduct or provides oversight to assigned medical monitors., • Presents results to Safety Monitoring Committee and other internal and external meetings., • May participate or lead Due Diligence projects in support of CSL’s external innovation efforts., • Reviews the data generated during the planning and execution of a study to gather a clinical understanding of the safety and efficacy results and the impact of the data on ongoing R&D strategies and provides support in defining the development strategy., • “Lead Author” or “Contributing” Author for key study documents, including but not limited to: the TPP, PSD, CDP, Study Concept Scenarios, Study Outlines, the Investigator Brochure (IB), Clinical Study Protocols (CSP), Master Informed Consent Forms (ICF), Medical Monitoring Plans (MMP), Safety Review Committee (SRC)/Independent Data Monitoring Committee (IDMC) Charters, and Clinical Study Reports (CSR)., • Leads preparations of clinical sections of relevant regulatory interaction packages including but not limited to briefing books, INDs, NDAs. BLAs, ODDs, RFIs, and routine reporting., • Contributing author the publication strategy. Author or contributing author for abstracts, presentations, and manuscripts as appropriate. Advanced degree (MD, PhD or PharmD) in life science/healthcare expected. MD - Board Certified (or non-USA equivalent) in relevant field is preferred. • Extensive clinical development industry experience with a working knowledge of pharmaceutical and regulatory development processes is essential., • 3-5 years of relevant clinical development experience is expected including experience of study data review/evaluation in a pharmaceutical or clinical study environment., • undefined, • Demonstrated program leadership capabilities in a matrix environment, • Proficient in project management terminology and processes to drive clinical development program risk mitigation strategies, • Excellent analytical thinking and scientific/medical writing skills, • Proficient in clinical data analysis and interpretation, • Strong problem-solving skills and the ability to think critically and make informed decisions, • Strong communication and presentation skills, • Builds bridges and proactively improves cross-functional collaboration The role can be based in Glattbrugg, Switzerland/ King of Prussia, USA / Waltham, USA/Maidenhead, UK and requires an onsite presence of 3 days per week. #J-18808-Ljbffr

An exceptional opportunity has arisen to join NHS Thames Valley Integrated Care Board as a Deputy Chief Medical Officer (DCMO), providing senior clinical leadership across the Integrated Care System and supporting the Chief Medical Officer in the delivery of the ICB's statutory, strategic and professional medical responsibilities. This is a senior system leadership role, requiring an experienced and credible clinical leader who can operate effectively across complex organisational boundaries to improve population health outcomes, reduce health inequalities and support the delivery of high-quality, value-based healthcare. This post-holder will be expected to complement the skills and capabilities of the other DCMOs and we would particularly welcome applications from colleagues with secondary care experience. Thames Valley Integrated Care Board plans and supports health and care services across Buckinghamshire, Oxfordshire and Berkshire. We work with partners to improve access, reduce health inequalities and deliver sustainable, person-centred care. Our values are Compassion, Collaboration and Excellence. They guide how we work with colleagues, communities and partners. We are committed to equality, diversity and inclusion, and to creating a respectful workplace where everyone can contribute. • Access to the NHS Pension Scheme, • Generous annual leave, • Sick pay arrangements, • Flexible working options, subject to service requirements, • Opportunities for learning and professional development. We want our workforce to reflect the communities we serve. We welcome applications from people of all backgrounds and particularly encourage applications from underrepresented groups. We are committed to making reasonable adjustments throughout the recruitment process. Please contact us if you would like to discuss an adjustment or request information in an alternative format. Disabled applicants who meet the essential criteria will be offered an interview, in line with our recruitment commitments. The role's senior clinical leadership portfolio includes: • Urgent and Emergency Care (UEC), Discharge Flow and Out-of-Hospital Care, • Community Health Services, • Long-Term Conditions, • Frailty, Dementia and End of Life Care, • Provide executive-level clinical leadership across the ICB and wider system., • Lead clinical transformation programmes and service improvement., • Support development and delivery of clinical and population health strategies., • Provide expert clinical advice on commissioning, quality and service redesign., • Build strong partnerships with providers, local authorities, primary care and wider system stakeholders., • Promote effective, sustainable, high quality healthcare., • Deputise for the Chief Medical Officer at Board, system and regional level as required. We welcome applications from senior clinicians with a strong track record of system leadership, transformation and partnership working. • Be a registered medical practitioner with the General Medical Council (GMC), • Evidence of continuous professional development, • Degree or equivalent management qualification or equivalent experience, • Evidence of continuing professional and managerial development, • Professional, calm and efficient manner, • An ability to maintain confidentiality and trust, • Positive and flexible approach to work, • Exceptional communication skills which engender community confidence, strong collaborations, and partnerships, • Strong critical thinking and strategic problem solving; analytical rigour and numeracy, • Highly sophisticated leadership and influencing skills; building compassionate cultures where individuals and teams thrive, • Demonstrates integrity, transparency, and a commitment to public service., • Compassionate leadership with a track record of improving equality, diversity, and inclusion and social justice., • Patient and community focused, with a passion for reducing health inequalities., • Innovative, proactive, and solution-oriented., • Collaborative, with the ability to build trust and effective relationships across boundaries., • Emotionally intelligent, resilient, and able to lead through complexity and change., • Openness, integrity, and creation of cultures that thrive on these values., • Compliance with the Nolan Principles of Public Life., • Committed to continuous learning and improvement., • Frequent travel across the ICB's geography, region and nationally may be required., • The postholder will be required to work flexibly and respond to emerging system priorities., • This job description serves as a guide to the nature and scope of the role and may be reviewed and amended in light of changing organisational needs., • A deep understanding of / professional connection with the Thames Valley system is desirable, to facilitate network relationships This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions. Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab) . From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab) . Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window). Thames Valley ICB King Edward V11 Hospital Windsor SL4 3DP United Kingdom https://www.thamesvalley.icb.nhs.uk/ (Opens in a new tab) Depending on experienceper annum pro rata #J-18808-Ljbffr

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Director, Senior Global Regulatory Lead (Sr.Global Regulatory Strategy (GRS).Location: King of Prussia, PA | Waltham, MA | Maidenhead, UK | Zurich, Switzerland.Work Arrangement: Hybrid – 3 days onsite per week.CSL’s R&D organization is accelerating innovation to deliver greater impact for patien

Director, Senior Global Regulatory Lead (Sr.Global Regulatory Strategy (GRS).Location: King of Prussia, PA | Waltham, MA | Maidenhead, UK | Zurich, Switzerland.Work Arrangement: Hybrid – 3 days onsite per week.CSL’s R&D organization is accelerating innovation to deliver greater impact for patien

My Four Wheels are looking to expand our team and are recruiting both part time and full time Driving Instructors though out the UK. We are looking for candidates who meet the following criteria –. After working with us for 1 year, we refund your training fees on a weekly basis up until year 3.

Earn extra money working hours that suit you. World famous beauty and cosmetics brand Avon is looking for full and part time representatives in the UK right now as business expands.

My Four Wheels are looking to expand our team and are recruiting both part time and full time Driving Instructors though out the UK. We are looking for candidates who meet the following criteria –. After working with us for 1 year, we refund your training fees on a weekly basis up until year 3.

World famous beauty and cosmetics brand Avon is looking for full and part time representatives in the UK right now as business expands. Earn extra money working hours that suit you.

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King's College Hospital NHS Foundation Trust's privacy notice. Our vision is to transform healthcare, and we have agreed six strategic ambitions to help us improve care for patients, and the working lives of our staff. King's is committed to delivering Sustainable Healthcare for All via our Green Pl

King’s College Hospital NHS Foundation Trust is seeking a Locum Consultant Gerontologist with an interest in Acute Frailty for a 12‑month fixed-term post in the Geriatrics & Frailty team.

MacKenzie King are partnering with a well-established and growing business to recruit a commercially focused Head of Finance.

MacKenzie King are excited to be partnering with a well-established and growing business to recruit a commercially focused. Provide meaningful financial analysis to support business decision-making. Manage rolling forecasts, cash flow planning, and working capital performance.

We are seeking a skilled and detail-oriented Architectural Technologist to join our team. Membership or working towards membership with a relevant professional body (e.

Reporting to the Managing Director and Board, this role plays a critical part in shaping financial strategy, driving performance, and enabling informed decision-making across the business. Ensure the ERP system supports business objectives and strategic decision-making.

King's College Hospital is part of King's Health Partners Academic Health Sciences Centre (AHSC), a pioneering collaboration between King's College London, and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts. In doing so, you can apply for flexible w

Red King Resourcing seeks BIM professionals to strengthen its building services capability in Bristol, Manchester, and Leeds.

King's College Hospital NHS Foundation Trust in London seeks a Consultant to lead and develop frailty services for older adults within a regional unit.

Red King Resourcing in the United Kingdom seeks a skilled TIG Welder / Sheet Metal Fabricator to join our manufacturing team in Slough.

MacKenzie King is seeking an Interim Financial Controller for a term of approximately 3 months to provide strategic financial leadership and robust risk management. You will report to the Managing Director and Board, shaping financial strategy, driving performance, and enabling informed decision‑m

Excel Aviation Ltd in Humberside is seeking a full-time B2 Line Certifying Engineer to join our Aircraft Maintenance Team. The role covers line maintenance on Beech King Air series aircraft and other company types, with travel to other sites as required.

We are seeking a skilled TIG Welder / Sheet Metal Fabricator to join our production team.

Period of appointment The substantive appointment is an ongoing academic Professorial contract, a permanent member of the academic staff of King's College London. When engaging in the robust exchange of ideas, we ask that our community is mindful of our Dignity at King's guidance. At King's, we beli

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The Park, part of Jeremy King Restaurants, is seeking an experienced sommelier to lead our wine program. Working closely with the front‑of‑house team, you will step in as Floor Manager when required to ensure every service runs smoothly.

Burger King UK is hiring a Restaurant Manager to run a busy BK restaurant with ownership of the P&L, driving sales and profitability while delivering high standards of service.

Strong organisation skills, taking full ownership of tasks and ensuring delivery within agreed deadlines. Individual differences are embraced at Stone King, and we strive to create an environment in which people feel supported and able to be themselves. Stone King LLP is an equal opportunities emplo

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You'll be right in the action, leading shifts, supporting your crew and making sure every guest leaves happy. If you're looking for responsibility, progression and a chance to grow as fast as we are - it might be time to swap crews and join ours.

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