Job description
Site Name:
Stevenage, GSK HQ, USA - Pennsylvania - Upper Providence, Wavre Posted Date:
Jan 15 2025 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Clinical Development Manager The primary responsibility of the NIS P&D Study Delivery Lead (SDL), Manager, is to lead the design, execution, and reporting of clinical studies and trials within the Non-Interventional Study (NIS) portfolio, including primary data collection studies and site-based studies delivered via Third Party suppliers. The NIS P&D SDL is accountable for the assessment, selection, engagement, and management of appropriate vendors and acts as the primary contact for vendor at study level. Job Purpose In this role you will be: Planning and leading the delivery of assigned studies to timelines, quality, budget, company standards and scientific requirements; from concept to final study report and archiving. Accountable for a study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools etc) which ensures consistency with asset plans. Accountable for the coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports. Taking ownership of operational problem-solving and decision-making. Making informed decisions that weigh risk versus benefit, with a clear understanding of the impact on the study and project. Proactively addresses risks and escalates issues to the NIS P&D TA Study Delivery Head when necessary. Building productive partnerships to support your studies and collaborating with therapy aligned staff in other functions. Interacting effectively across boundaries with other global functions using influencing and relationship-building skills. Ensuring compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for NIS such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered on your designated studies. Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree in life sciences or related discipline + experience in clinical operations or related research. Knowledge and experience of Non-Interventional Studies (NIS), Registry studies, Phase IV clinical trials or PASS/PAES. Ability to work independently and proactively and to take on leadership roles in cross-functional teams. Demonstrated experience leading in a matrix environment to deliver studies, develop clinical plans, and manage change. Ability to establish and build internal and external relationships (e.g. Third Party suppliers) at all levels in a highly dynamic and matrixed environment. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience. Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams. Proven experience in managing relationships with vendors to ensure successful delivery of studies. Demonstrated in-depth knowledge of study management, essential regulatory guidelines worldwide, and the clinical development process. Experience with budgeting and forecasting, commercial and financial acumen. Closing Date for Applications – 26th January 2025 Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class (US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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Stevenage, GSK HQ, USA - Pennsylvania - Upper Providence, Wavre Posted Date:
Jan 15 2025 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Clinical Development Manager The primary responsibility of the NIS P&D Study Delivery Lead (SDL), Manager, is to lead the design, execution, and reporting of clinical studies and trials within the Non-Interventional Study (NIS) portfolio, including primary data collection studies and site-based studies delivered via Third Party suppliers. The NIS P&D SDL is accountable for the assessment, selection, engagement, and management of appropriate vendors and acts as the primary contact for vendor at study level. Job Purpose In this role you will be: Planning and leading the delivery of assigned studies to timelines, quality, budget, company standards and scientific requirements; from concept to final study report and archiving. Accountable for a study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools etc) which ensures consistency with asset plans. Accountable for the coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports. Taking ownership of operational problem-solving and decision-making. Making informed decisions that weigh risk versus benefit, with a clear understanding of the impact on the study and project. Proactively addresses risks and escalates issues to the NIS P&D TA Study Delivery Head when necessary. Building productive partnerships to support your studies and collaborating with therapy aligned staff in other functions. Interacting effectively across boundaries with other global functions using influencing and relationship-building skills. Ensuring compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for NIS such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered on your designated studies. Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree in life sciences or related discipline + experience in clinical operations or related research. Knowledge and experience of Non-Interventional Studies (NIS), Registry studies, Phase IV clinical trials or PASS/PAES. Ability to work independently and proactively and to take on leadership roles in cross-functional teams. Demonstrated experience leading in a matrix environment to deliver studies, develop clinical plans, and manage change. Ability to establish and build internal and external relationships (e.g. Third Party suppliers) at all levels in a highly dynamic and matrixed environment. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience. Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams. Proven experience in managing relationships with vendors to ensure successful delivery of studies. Demonstrated in-depth knowledge of study management, essential regulatory guidelines worldwide, and the clinical development process. Experience with budgeting and forecasting, commercial and financial acumen. Closing Date for Applications – 26th January 2025 Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class (US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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