Overview Capability Manager - Global Medical Affairs The location of the role is London (hybrid working). The duration of the contract is 9 months. The pay rate on offer is £600 - £650 per day (via Umbrella agency - inside IR35). Responsibilities Manage the implementation of capability initiatives and quality control of final deliverables. In partnership with Capability Directors, drive the needs assessments, capability program design, delivery, measurement and embedding with a strong focus on external engagement excellence & evidence generation. Ensure successful delivery and deployment of capability initiatives via effective stakeholder management and planning. Shape company-wide capability programmes providing the unique MA perspective to ensure relevancy and impact. Explore future trends, innovation and digital advances and integrate into capability initiatives to drive an effective and engaging learner experience. Aptly manage vendors to ensure high quality deliverables and efficient spend in areas such as external engagement, MSL Leader Coaching driving consistent global standards. Lead the development of key internal capability resource sites maintaining content over time to ensure relevancy. Track capability program budget liaising with Capability Director to flag key risks and opportunities. Lead continuous improvement to ensure impactful and relevant capability programs that accelerate employee upskilling and drive desired performance change with a focus on evidence generation and patient-focused development. Build an advisory network of SMEs to inform program design at a local and global level for key programs, keeping pace with evolving healthcare landscapes. Continually assess external environment for key trends and insights and determine implications for capability building within Medical Affairs. Basic Qualifications Post secondary degree. 5 or more years of experience in a pharmaceutical setting. 3 or more years of project management or similar operational experience. Experience with regulatory codes of Promotion and Scientific Engagement (e.g. IMC). Strong interpersonal, organizational, written and oral communications skills. Superlative presentation skills, across lines and levels and with senior stakeholders. Ability to think strategically and adapt to shifting priorities. Ability to think critically, analyzing and evaluating options to inform well thought-out decisions. Ability to manage multiple priorities and stakeholders while maintaining attention to detail. Experience with leading transformational projects, aligned with organizational strategy. Experience in working with different time-zones and cultures. Preferred Qualifications MBA Excellent understanding of medical functions and medical affairs activities. Ability to develop relationships based upon trust and mutual respect. Experience with building capabilities and/or implementing change initiatives.
Mar 07, 2026
Full time
Overview Capability Manager - Global Medical Affairs The location of the role is London (hybrid working). The duration of the contract is 9 months. The pay rate on offer is £600 - £650 per day (via Umbrella agency - inside IR35). Responsibilities Manage the implementation of capability initiatives and quality control of final deliverables. In partnership with Capability Directors, drive the needs assessments, capability program design, delivery, measurement and embedding with a strong focus on external engagement excellence & evidence generation. Ensure successful delivery and deployment of capability initiatives via effective stakeholder management and planning. Shape company-wide capability programmes providing the unique MA perspective to ensure relevancy and impact. Explore future trends, innovation and digital advances and integrate into capability initiatives to drive an effective and engaging learner experience. Aptly manage vendors to ensure high quality deliverables and efficient spend in areas such as external engagement, MSL Leader Coaching driving consistent global standards. Lead the development of key internal capability resource sites maintaining content over time to ensure relevancy. Track capability program budget liaising with Capability Director to flag key risks and opportunities. Lead continuous improvement to ensure impactful and relevant capability programs that accelerate employee upskilling and drive desired performance change with a focus on evidence generation and patient-focused development. Build an advisory network of SMEs to inform program design at a local and global level for key programs, keeping pace with evolving healthcare landscapes. Continually assess external environment for key trends and insights and determine implications for capability building within Medical Affairs. Basic Qualifications Post secondary degree. 5 or more years of experience in a pharmaceutical setting. 3 or more years of project management or similar operational experience. Experience with regulatory codes of Promotion and Scientific Engagement (e.g. IMC). Strong interpersonal, organizational, written and oral communications skills. Superlative presentation skills, across lines and levels and with senior stakeholders. Ability to think strategically and adapt to shifting priorities. Ability to think critically, analyzing and evaluating options to inform well thought-out decisions. Ability to manage multiple priorities and stakeholders while maintaining attention to detail. Experience with leading transformational projects, aligned with organizational strategy. Experience in working with different time-zones and cultures. Preferred Qualifications MBA Excellent understanding of medical functions and medical affairs activities. Ability to develop relationships based upon trust and mutual respect. Experience with building capabilities and/or implementing change initiatives.
Job Details: Director, Safety Operations Vacancy No: VN757 Employment Type: Full Time Location: Oxford, UK Department: Regulatory Affairs Key Responsibilities The Director, Safety Operations is a senior pharmacovigilance operations leader accountable for the end to end execution, quality, and continuous improvement of global safety operations for Immunocore's development and marketed products. The role holder is an experienced pharmacovigilance professional with deep expertise in case management, safety systems, PV compliance, and vendor oversight. Lead and continuously improve global safety operations processes, including case intake, processing, and submissions, ensuring alignment with global PV regulations and company policies. Oversee timely and compliant case processing and regulatory reporting of Individual Case Safety Reports (ICSRs) from all sources. Ensure robust operational oversight of internal and external safety case management, including performance monitoring and quality metrics. Provide strategic leadership for the selection, configuration, validation, and life-cycle management of safety systems and tools, in partnership with IT and Safety Systems teams. Lead the design, implementation, and maintenance of standard operating procedures (SOPs), work instructions, and training for safety operations. Ensure inspection readiness and support internal audits, Health Authority inspections, and partner audits related to PV operations, coordinating responses and remediation plans. Collaborate with Safety Physicians and cross-functional teams to ensure high-quality data for signal detection, aggregate safety reporting, benefit-risk assessments, and Risk Management Plans (RMPs). Provide senior operational input into Safety Management Teams and cross-functional project teams, managing operational feasibility, timelines, and compliance risks. Lead operational aspects of safety data exchange agreements (SDEAs) with partners and licensees and oversee literature surveillance workflows. Recruit, lead, and develop a Global Safety Operations team, manage budgets and resources, and act as the primary point of contact for safety operations with internal stakeholders. Supervisory Responsibility This position has direct line management responsibilities for a team of global safety operations professionals with matrix oversight of additional staff or vendor teams performing PV operational activities. Competencies Strong expertise in pharmacovigilance operations, including case processing, regulatory reporting, PV systems, and vendor oversight in a GVP regulated environment. Demonstrated leadership and people management skills, with experience building and developing teams. Strong analytical, organizational, and project management skills, with the ability to manage multiple priorities and deliver high quality outcomes to tight timelines. Excellent written and verbal communication skills, able to convey complex operational and regulatory concepts clearly to both technical and non-technical audiences. Proven ability to collaborate effectively across functions and regions, building strong relationships and influencing without direct authority. High level of integrity, discretion, and commitment to patient safety, compliance, and ethical conduct. Experience & Knowledge Essential Extensive experience (5+ years) in pharmacovigilance operations, with significant leadership in global ICSR management and regulatory reporting. In depth knowledge of global PV regulations (GVP, ICH, FDA, MHRA, EMA) and proven ability to implement them operationally. Strong experience with safety databases and PV systems, including configuration, validation, and maintenance. Demonstrated ability to lead, and manage a team of PV professionals and oversee PV vendors/CROs. Proven track record in preparing for and supporting Health Authority inspections and audits, alongside strong project management skills. Desirable Advanced degree in a relevant scientific or health-related field. Experience with safety data exchange agreements (SDEAs) and literature surveillance. Demonstrated ability to drive continuous improvement, process optimization, and automation in PV operations. Familiarity with operational support for Risk Management Plans (RMPs) and aggregate safety reports. Demonstrated understanding of clinical development processes. Experience with global product launches and implementation/assessment of complex risk minimisation measures. Evidence of scientific contributions to the field (e.g., peer reviewed publications, invited presentations, guideline development, or recognised subject matter expertise in biologic safety). Education & Qualifications Bachelor's degree or equivalent in a life science, pharmacy, nursing, or a related health field. Relevant certifications in pharmacovigilance or drug safety are highly desirable. About the Company Immunocore (NASDAQ: IMCR) is a pioneering, commercial stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions. Focused on delivering first in class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases. At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits. Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
Mar 03, 2026
Full time
Job Details: Director, Safety Operations Vacancy No: VN757 Employment Type: Full Time Location: Oxford, UK Department: Regulatory Affairs Key Responsibilities The Director, Safety Operations is a senior pharmacovigilance operations leader accountable for the end to end execution, quality, and continuous improvement of global safety operations for Immunocore's development and marketed products. The role holder is an experienced pharmacovigilance professional with deep expertise in case management, safety systems, PV compliance, and vendor oversight. Lead and continuously improve global safety operations processes, including case intake, processing, and submissions, ensuring alignment with global PV regulations and company policies. Oversee timely and compliant case processing and regulatory reporting of Individual Case Safety Reports (ICSRs) from all sources. Ensure robust operational oversight of internal and external safety case management, including performance monitoring and quality metrics. Provide strategic leadership for the selection, configuration, validation, and life-cycle management of safety systems and tools, in partnership with IT and Safety Systems teams. Lead the design, implementation, and maintenance of standard operating procedures (SOPs), work instructions, and training for safety operations. Ensure inspection readiness and support internal audits, Health Authority inspections, and partner audits related to PV operations, coordinating responses and remediation plans. Collaborate with Safety Physicians and cross-functional teams to ensure high-quality data for signal detection, aggregate safety reporting, benefit-risk assessments, and Risk Management Plans (RMPs). Provide senior operational input into Safety Management Teams and cross-functional project teams, managing operational feasibility, timelines, and compliance risks. Lead operational aspects of safety data exchange agreements (SDEAs) with partners and licensees and oversee literature surveillance workflows. Recruit, lead, and develop a Global Safety Operations team, manage budgets and resources, and act as the primary point of contact for safety operations with internal stakeholders. Supervisory Responsibility This position has direct line management responsibilities for a team of global safety operations professionals with matrix oversight of additional staff or vendor teams performing PV operational activities. Competencies Strong expertise in pharmacovigilance operations, including case processing, regulatory reporting, PV systems, and vendor oversight in a GVP regulated environment. Demonstrated leadership and people management skills, with experience building and developing teams. Strong analytical, organizational, and project management skills, with the ability to manage multiple priorities and deliver high quality outcomes to tight timelines. Excellent written and verbal communication skills, able to convey complex operational and regulatory concepts clearly to both technical and non-technical audiences. Proven ability to collaborate effectively across functions and regions, building strong relationships and influencing without direct authority. High level of integrity, discretion, and commitment to patient safety, compliance, and ethical conduct. Experience & Knowledge Essential Extensive experience (5+ years) in pharmacovigilance operations, with significant leadership in global ICSR management and regulatory reporting. In depth knowledge of global PV regulations (GVP, ICH, FDA, MHRA, EMA) and proven ability to implement them operationally. Strong experience with safety databases and PV systems, including configuration, validation, and maintenance. Demonstrated ability to lead, and manage a team of PV professionals and oversee PV vendors/CROs. Proven track record in preparing for and supporting Health Authority inspections and audits, alongside strong project management skills. Desirable Advanced degree in a relevant scientific or health-related field. Experience with safety data exchange agreements (SDEAs) and literature surveillance. Demonstrated ability to drive continuous improvement, process optimization, and automation in PV operations. Familiarity with operational support for Risk Management Plans (RMPs) and aggregate safety reports. Demonstrated understanding of clinical development processes. Experience with global product launches and implementation/assessment of complex risk minimisation measures. Evidence of scientific contributions to the field (e.g., peer reviewed publications, invited presentations, guideline development, or recognised subject matter expertise in biologic safety). Education & Qualifications Bachelor's degree or equivalent in a life science, pharmacy, nursing, or a related health field. Relevant certifications in pharmacovigilance or drug safety are highly desirable. About the Company Immunocore (NASDAQ: IMCR) is a pioneering, commercial stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions. Focused on delivering first in class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases. At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits. Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
A leading biopharmaceutical company based in the United Kingdom seeks a Senior Director for Managed Access in Global Medical Affairs to drive strategic initiatives across therapeutic areas. This role requires a strong leader with extensive experience in the pharmaceutical sector and a deep understanding of global regulatory frameworks. Key responsibilities include overseeing managed access programs and leading a high-performing team, with a focus on compliance and performance excellence. Competitive salary and hybrid working environment offered.
Mar 02, 2026
Full time
A leading biopharmaceutical company based in the United Kingdom seeks a Senior Director for Managed Access in Global Medical Affairs to drive strategic initiatives across therapeutic areas. This role requires a strong leader with extensive experience in the pharmaceutical sector and a deep understanding of global regulatory frameworks. Key responsibilities include overseeing managed access programs and leading a high-performing team, with a focus on compliance and performance excellence. Competitive salary and hybrid working environment offered.
Job description Site Name: USA - Pennsylvania - Upper Providence, UK London New Oxford Street, USA - Massachusetts - Boston Posted Date: Feb 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&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. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D About RIIRU The Respiratory, Immunology and Inflammation Research Unit (RIIRU) was formed in 2024 to identify and advance novel molecular targets with genetic associations to disease based on the foundational observation that targets with human genetic evidence supporting their causal role in the intended indication improves clinical success by two fold. The remit of RIIRU is to identify novel targets based on human genetics, develop assets for clinical studies, and perform trials through to submission for approvals. This goal is enabled through strategic external (e.g., Flagship Pioneering, Vesalius, Muna Therapeutics and others) and GSK internal partnerships (Research Technologies). PLEASE NOTE: This career opportunity requires an on site office presence (minimum of two days a week) at one of GSK's US (PA or MA) or UK (Stevenage or London HQ) sites. Position Summary A Senior Scientific Director, Clinical Development is sought to provide clinical and scientific leadership for potential new, established and emerging indications for assets in clinical development with a strong focus in respiratory disease. You will work with project teams to plan and ensure delivery of clinical research and development activities and establish efficient collaboration throughout all stages of development. You will report to the Vice President, Clinical Research Head, Respiratory. This role is pivotal in driving GSK's mission to deliver transformative medicines to patients, ensuring clinical excellence, regulatory compliance, and operational efficiency. The successful candidate will not only deliver results but also inspire and empower teams to achieve exceptional outcomes. Lead the clinical development strategy from a drug or program including accountability for the clinical components of the Target Medicine Profile (TMP) and leadership of the clinical matrix team (CMT). Ensure cohesive and comprehensive clinical development plans (CDP) for product(s) and/or indication(s). Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients. Contribute to development of the Integrated Evidence Strategy (IES), including oversight of the CDP and its component clinical trials. Integrate scientific rationale, regulatory requirements, product development plans, and commercial goals to optimize asset indications and programs, providing strategic leadership in assuring that clinical study designs are aligned with the IES and CDP. Drive ambitious and achievable clinical development timelines, incorporating key decision points, risk and cost analyses, and Go/No Go criteria. Lead and be accountable for the evaluation of the probability of technical success (PTRS) of clinical studies/programs. Assess risk/benefit at the study and/or project level and take action to mitigate risk where appropriate. Nurture and maintain relationships with counterparts in Commercial, Regulatory, Clinical Operations, Medical Affairs, and Statistics. Serve as a clinical point of contact for senior management and senior level matrix teams, across the internal matrix and positively interface and influence a broad range of external experts (e.g., regulators, payors, CROs, consultants, investigators). Lead clinical development discussions and teams at global regulatory interactions. Make substantial contributions to global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including briefing documents, presentations, and responses to regulatory questions. Manage technical and leadership development of Clinical Development staff via direct line management, mentoring and coaching across the organisation. Manage and contribute to the development of strategic initiatives, specific business development activities including due diligence, and organisational initiatives in Clinical Development, championing innovative methodologies and processes including digital tools and technology, encouraging others to think differently and adopt new ways of working. Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space to maintain GSK's competitive edge. Excel in ambiguous situations by demonstrating strong problem solving skills and innovative thinking. Anticipate potential challenges, develop strategic approaches, and effectively communicate uncertainty to stakeholders while guiding teams through unclear circumstances. Adept at identifying opportunities for synergy and innovation across the organisation and influencing others to adopt an enterprise mindset. Use strategic thinking to analyze, interpret, and critically evaluate complex data and information. Anticipate obstacles and identify innovative solutions to ensure timely delivery of evidence that supports regulatory approvals and patient benefit. Skilled in understanding individual motivations and tailoring approaches to team members to drive commitment, a strong track record of inspiring and leading others to achieve exceptional results. Navigate ambiguity by anticipating regulatory challenges and proactively addressing issues. Basic Qualifications Advanced Degree Required: PhD or PharmD Minimum of 5 years of experience in Respiratory clinical research and development, may include postgrad experience. Minimum of 3 years of experience of contributing to or leading a global clinical development program in the biopharmaceutical industry. Experience working with global regulatory agencies and managing global clinical trials in respiratory disease Preferred Qualifications MD preferred but not required Proven track record of successfully leading cross functional teams and executing industry sponsored clinical trials. In depth knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research. Demonstrated ability to work independently to design trials to regulatory standards from concept to completion. Demonstrated leadership/People Management experience in clinical practice, academia and/or industry, leading line and matrix teams with a reputation of inspiring and motivating high performance. Experience in setting and executing scientific strategy preferred. Experience in translational medicine preferred. Experience in leading NDA, BLA, or MAA submissions preferred. Salary and Compensation If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $242,550 to $404,250. If you are based in another US location, the annual base salary range is $220,500 to $367,500. US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call. Please note should your inquiry not relate to adjustments . click apply for full job details
Feb 25, 2026
Full time
Job description Site Name: USA - Pennsylvania - Upper Providence, UK London New Oxford Street, USA - Massachusetts - Boston Posted Date: Feb 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&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. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D About RIIRU The Respiratory, Immunology and Inflammation Research Unit (RIIRU) was formed in 2024 to identify and advance novel molecular targets with genetic associations to disease based on the foundational observation that targets with human genetic evidence supporting their causal role in the intended indication improves clinical success by two fold. The remit of RIIRU is to identify novel targets based on human genetics, develop assets for clinical studies, and perform trials through to submission for approvals. This goal is enabled through strategic external (e.g., Flagship Pioneering, Vesalius, Muna Therapeutics and others) and GSK internal partnerships (Research Technologies). PLEASE NOTE: This career opportunity requires an on site office presence (minimum of two days a week) at one of GSK's US (PA or MA) or UK (Stevenage or London HQ) sites. Position Summary A Senior Scientific Director, Clinical Development is sought to provide clinical and scientific leadership for potential new, established and emerging indications for assets in clinical development with a strong focus in respiratory disease. You will work with project teams to plan and ensure delivery of clinical research and development activities and establish efficient collaboration throughout all stages of development. You will report to the Vice President, Clinical Research Head, Respiratory. This role is pivotal in driving GSK's mission to deliver transformative medicines to patients, ensuring clinical excellence, regulatory compliance, and operational efficiency. The successful candidate will not only deliver results but also inspire and empower teams to achieve exceptional outcomes. Lead the clinical development strategy from a drug or program including accountability for the clinical components of the Target Medicine Profile (TMP) and leadership of the clinical matrix team (CMT). Ensure cohesive and comprehensive clinical development plans (CDP) for product(s) and/or indication(s). Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients. Contribute to development of the Integrated Evidence Strategy (IES), including oversight of the CDP and its component clinical trials. Integrate scientific rationale, regulatory requirements, product development plans, and commercial goals to optimize asset indications and programs, providing strategic leadership in assuring that clinical study designs are aligned with the IES and CDP. Drive ambitious and achievable clinical development timelines, incorporating key decision points, risk and cost analyses, and Go/No Go criteria. Lead and be accountable for the evaluation of the probability of technical success (PTRS) of clinical studies/programs. Assess risk/benefit at the study and/or project level and take action to mitigate risk where appropriate. Nurture and maintain relationships with counterparts in Commercial, Regulatory, Clinical Operations, Medical Affairs, and Statistics. Serve as a clinical point of contact for senior management and senior level matrix teams, across the internal matrix and positively interface and influence a broad range of external experts (e.g., regulators, payors, CROs, consultants, investigators). Lead clinical development discussions and teams at global regulatory interactions. Make substantial contributions to global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including briefing documents, presentations, and responses to regulatory questions. Manage technical and leadership development of Clinical Development staff via direct line management, mentoring and coaching across the organisation. Manage and contribute to the development of strategic initiatives, specific business development activities including due diligence, and organisational initiatives in Clinical Development, championing innovative methodologies and processes including digital tools and technology, encouraging others to think differently and adopt new ways of working. Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space to maintain GSK's competitive edge. Excel in ambiguous situations by demonstrating strong problem solving skills and innovative thinking. Anticipate potential challenges, develop strategic approaches, and effectively communicate uncertainty to stakeholders while guiding teams through unclear circumstances. Adept at identifying opportunities for synergy and innovation across the organisation and influencing others to adopt an enterprise mindset. Use strategic thinking to analyze, interpret, and critically evaluate complex data and information. Anticipate obstacles and identify innovative solutions to ensure timely delivery of evidence that supports regulatory approvals and patient benefit. Skilled in understanding individual motivations and tailoring approaches to team members to drive commitment, a strong track record of inspiring and leading others to achieve exceptional results. Navigate ambiguity by anticipating regulatory challenges and proactively addressing issues. Basic Qualifications Advanced Degree Required: PhD or PharmD Minimum of 5 years of experience in Respiratory clinical research and development, may include postgrad experience. Minimum of 3 years of experience of contributing to or leading a global clinical development program in the biopharmaceutical industry. Experience working with global regulatory agencies and managing global clinical trials in respiratory disease Preferred Qualifications MD preferred but not required Proven track record of successfully leading cross functional teams and executing industry sponsored clinical trials. In depth knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research. Demonstrated ability to work independently to design trials to regulatory standards from concept to completion. Demonstrated leadership/People Management experience in clinical practice, academia and/or industry, leading line and matrix teams with a reputation of inspiring and motivating high performance. Experience in setting and executing scientific strategy preferred. Experience in translational medicine preferred. Experience in leading NDA, BLA, or MAA submissions preferred. Salary and Compensation If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $242,550 to $404,250. If you are based in another US location, the annual base salary range is $220,500 to $367,500. US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call. Please note should your inquiry not relate to adjustments . click apply for full job details
Hanson Search is representing a global technology group operating at the forefront of radiation safety, nuclear instrumentation and high-integrity imaging systems. We are seeking a Managing Director to lead the UK operations for a global technology group. This Managing Director UK nuclear leadership role carries full commercial and operational accountability across multiple sites serving highly regulated sectors. Our client is an internationally recognised leader delivering critical solutions that enable safer workplaces, support defence and energy infrastructure, and underpin life-saving medical and scientific applications. With several thousand employees worldwide, the organisation combines engineering excellence, regulatory rigour, and innovation to serve highly regulated and mission-critical sectors. Managing Director UK Nuclear Leadership Opportunity - Full P&L Responsibility This is a high-impact Managing Director UK nuclear leadership role with full P&L responsibility across multiple UK sites. The Managing Director will report directly to the Regional President (EMEA & APAC) and will hold complete accountability for strategy execution, financial performance, operational excellence and cultural leadership across the UK platform. Role Purpose - Strategic Growth, Operational Excellence & Regulatory Leadership in the UK To provide strategic, commercial and organisational leadership to the UK businesses by: Defining and executing a clear growth strategy aligned with regional and global objectives Driving operational excellence and regulatory compliance within highly controlled environments Building a high-performance, accountable and inclusive culture Ensuring long-term profitability, sustainability and market competitiveness This role requires both strategic vision and hands on leadership capability. Key Responsibilities of the Managing Director - UK Strategic & Commercial Leadership in Nuclear, Defence & Energy Markets Define and deliver the UK growth strategy in alignment with international objectives Strengthen market position across nuclear, defence, medical and industrial sectors Identify new market opportunities, partnerships and revenue streams Monitor competitive and regulatory trends and adapt strategy accordingly Operational Leadership Across Engineering, Manufacturing & Technical Services Oversee daily operations across engineering, manufacturing, sales and service Drive continuous improvement in productivity, quality and compliance Ensure adherence to UK regulatory, legal and corporate governance standards Lead risk identification and mitigation strategies Financial Leadership & P&L Accountability Full P&L ownership Responsibility for net working capital, cash generation and forecasting Budget management and performance optimisation Ensure sustainable profitability and disciplined capital allocation Executive Leadership, Culture & Organisational Development Lead, mentor and develop the senior management team Build a performance driven, collaborative and inclusive culture Lead organisational transformation and change initiatives Act as the visible leader of the UK business internally and externally Senior Stakeholder & Board Level Engagement Develop strong relationships with customers, partners and regulators Represent the UK business within the wider international organisation Maintain credibility at executive and board level Candidate Profile - Senior Engineering & Nuclear Sector Leadership Experience Extensive experience in a senior leadership or general management role Experience within nuclear, radiation technologies, highly regulated engineering, defence, energy, scientific instrumentation or adjacent sectors Demonstrable P&L ownership and financial accountability If you have the relevant experience and this opportunity sounds interesting, please get in touch with our team, including a copy of your CV via the form below. Hanson Search is a globally recognised, award winning talent advisory and headhunting consultancy. Our expertise lies in building successful ventures worldwide through our recruitment, interim and executive search incommunications, sustainability,public affairs and policy, digital marketing andsales and commercial. Furthermore, we are committed to equality of opportunity for all. You can access our Diversity and Inclusion Policy here.
Feb 21, 2026
Full time
Hanson Search is representing a global technology group operating at the forefront of radiation safety, nuclear instrumentation and high-integrity imaging systems. We are seeking a Managing Director to lead the UK operations for a global technology group. This Managing Director UK nuclear leadership role carries full commercial and operational accountability across multiple sites serving highly regulated sectors. Our client is an internationally recognised leader delivering critical solutions that enable safer workplaces, support defence and energy infrastructure, and underpin life-saving medical and scientific applications. With several thousand employees worldwide, the organisation combines engineering excellence, regulatory rigour, and innovation to serve highly regulated and mission-critical sectors. Managing Director UK Nuclear Leadership Opportunity - Full P&L Responsibility This is a high-impact Managing Director UK nuclear leadership role with full P&L responsibility across multiple UK sites. The Managing Director will report directly to the Regional President (EMEA & APAC) and will hold complete accountability for strategy execution, financial performance, operational excellence and cultural leadership across the UK platform. Role Purpose - Strategic Growth, Operational Excellence & Regulatory Leadership in the UK To provide strategic, commercial and organisational leadership to the UK businesses by: Defining and executing a clear growth strategy aligned with regional and global objectives Driving operational excellence and regulatory compliance within highly controlled environments Building a high-performance, accountable and inclusive culture Ensuring long-term profitability, sustainability and market competitiveness This role requires both strategic vision and hands on leadership capability. Key Responsibilities of the Managing Director - UK Strategic & Commercial Leadership in Nuclear, Defence & Energy Markets Define and deliver the UK growth strategy in alignment with international objectives Strengthen market position across nuclear, defence, medical and industrial sectors Identify new market opportunities, partnerships and revenue streams Monitor competitive and regulatory trends and adapt strategy accordingly Operational Leadership Across Engineering, Manufacturing & Technical Services Oversee daily operations across engineering, manufacturing, sales and service Drive continuous improvement in productivity, quality and compliance Ensure adherence to UK regulatory, legal and corporate governance standards Lead risk identification and mitigation strategies Financial Leadership & P&L Accountability Full P&L ownership Responsibility for net working capital, cash generation and forecasting Budget management and performance optimisation Ensure sustainable profitability and disciplined capital allocation Executive Leadership, Culture & Organisational Development Lead, mentor and develop the senior management team Build a performance driven, collaborative and inclusive culture Lead organisational transformation and change initiatives Act as the visible leader of the UK business internally and externally Senior Stakeholder & Board Level Engagement Develop strong relationships with customers, partners and regulators Represent the UK business within the wider international organisation Maintain credibility at executive and board level Candidate Profile - Senior Engineering & Nuclear Sector Leadership Experience Extensive experience in a senior leadership or general management role Experience within nuclear, radiation technologies, highly regulated engineering, defence, energy, scientific instrumentation or adjacent sectors Demonstrable P&L ownership and financial accountability If you have the relevant experience and this opportunity sounds interesting, please get in touch with our team, including a copy of your CV via the form below. Hanson Search is a globally recognised, award winning talent advisory and headhunting consultancy. Our expertise lies in building successful ventures worldwide through our recruitment, interim and executive search incommunications, sustainability,public affairs and policy, digital marketing andsales and commercial. Furthermore, we are committed to equality of opportunity for all. You can access our Diversity and Inclusion Policy here.
Senior Director, Biostatistical Consulting ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Director, Biostatistics Consulting to join our diverse and dynamic team. As a Senior Director, you will play a pivotal role in leading our biostatistics consulting practice, providing expert statistical guidance, and driving the strategic direction for biostatistical support in clinical trials. You will contribute to the success of our projects by delivering high-quality statistical analysis, ensuring regulatory compliance, and enhancing data-driven decision-making across our organization. What You Will Be Doing: Leading the biostatistics consulting practice, overseeing the development and implementation of statistical strategies and methodologies to support clinical research and regulatory submissions. Providing expert biostatistical guidance on study design, statistical analysis, and data interpretation to ensure high-quality and scientifically valid results. Collaborating with cross-functional teams, including clinical and regulatory affairs, to align biostatistical approaches with study objectives and regulatory requirements. Developing and implementing best practices for statistical consulting, ensuring adherence to industry standards and promoting innovative solutions for complex statistical challenges. Building and maintaining strong relationships with clients and stakeholders, delivering expert consulting services, and driving strategic growth in the biostatistics practice. When required attending sponsor meetings with regulatory authorities. Your Profile: Advanced degree in biostatistics, statistics, or a related field, with significant experience in biostatistics consulting and clinical trial support. Extensive experience in designing and analysing clinical trials, with a deep understanding of regulatory requirements and statistical methodologies. Working knowledge of the application of Bayesian methodologies in a clinical research environment. Proven track record of leading and managing biostatistics teams, with strong expertise in strategic planning and client management. Excellent problem-solving skills, with the ability to address complex statistical issues and drive innovative solutions. Proven track record of authoring the statistical sections of regulatory submissions and responding to regulatory questions. Outstanding communication, interpersonal, and leadership skills, with the ability to present complex statistical concepts clearly and collaborate effectively with stakeholders across the organization. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply
Feb 19, 2026
Full time
Senior Director, Biostatistical Consulting ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Director, Biostatistics Consulting to join our diverse and dynamic team. As a Senior Director, you will play a pivotal role in leading our biostatistics consulting practice, providing expert statistical guidance, and driving the strategic direction for biostatistical support in clinical trials. You will contribute to the success of our projects by delivering high-quality statistical analysis, ensuring regulatory compliance, and enhancing data-driven decision-making across our organization. What You Will Be Doing: Leading the biostatistics consulting practice, overseeing the development and implementation of statistical strategies and methodologies to support clinical research and regulatory submissions. Providing expert biostatistical guidance on study design, statistical analysis, and data interpretation to ensure high-quality and scientifically valid results. Collaborating with cross-functional teams, including clinical and regulatory affairs, to align biostatistical approaches with study objectives and regulatory requirements. Developing and implementing best practices for statistical consulting, ensuring adherence to industry standards and promoting innovative solutions for complex statistical challenges. Building and maintaining strong relationships with clients and stakeholders, delivering expert consulting services, and driving strategic growth in the biostatistics practice. When required attending sponsor meetings with regulatory authorities. Your Profile: Advanced degree in biostatistics, statistics, or a related field, with significant experience in biostatistics consulting and clinical trial support. Extensive experience in designing and analysing clinical trials, with a deep understanding of regulatory requirements and statistical methodologies. Working knowledge of the application of Bayesian methodologies in a clinical research environment. Proven track record of leading and managing biostatistics teams, with strong expertise in strategic planning and client management. Excellent problem-solving skills, with the ability to address complex statistical issues and drive innovative solutions. Proven track record of authoring the statistical sections of regulatory submissions and responding to regulatory questions. Outstanding communication, interpersonal, and leadership skills, with the ability to present complex statistical concepts clearly and collaborate effectively with stakeholders across the organization. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply
