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Director, Clinical Research and Early Programs Immunology
Site Name:
UK - Hertfordshire - Stevenage, UK - London - New Oxford Street Posted Date:
Nov 14 2024
Please note this role requires to be based in a UK GSK site for a minimum of 2 days per week.
Are you an Immunologist/Rheumatologist with a passion for developing new treatments for patients? This Medical Director role in our Respiratory & Immunology Research Unit (RIRU) may be of interest.
Our RIRU is committed to leading the way in Respiratory & Immunology Clinical Research, harnessing the power of the immune system, patient biology and predictive technologies. We are focused on bridging the gap between research and clinical practice to maximise pipeline value and enhance patient lives globally.
Key Responsibilities
The responsibilities of the Director Clinical Research and Early Programs Immunology include (but are not limited to):
Designing and leading clinical development protocols/studies/programs in Immunology across all phases of development, as required by business imperatives as part of clinical and medicine development matrix teams. Clinical development strategy including study Ph1-2/3 design. Providing clinical expert input into regulatory documentation and leading regulatory interactions from clinical perspective for their studies/indications, as appropriate. Working closely with Research Unit members to define prioritized clinical indications for early targets and integrate inputs from across disciplines (scientific, clinical, commercial, regulatory and stats) to contribute to the Medicine Profile, Target Validation, Translational Plans, Candidate Selection, clinical development plan and integrated evidence plan. Design and delivery of an early clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile to support progression to full development. Accountability for design and delivery of the full development clinical development plan that effectively demonstrates benefit-risk and leads to a successful submission to regulators, payors etc. Leading the integrated evidence planning to address the needs of regulators, payors, and patients. Participating/leading the clinical Team (CT) (or equivalent cross-functional clinical team) and Integrated Evidence Team (IET). Engaging external academic and clinical experts to enhance quality and delivery of clinical programs/studies. Providing clinical input into presentations and supporting documentation for governance bodies, as requested. Accountability for escalation of clinical safety incidents to the Immunology Clinical Research and Early Programs Head and GSK Pharmacovigilance, as appropriate. Clinical input to regulatory documentation to support the desired indication (e.g., IB, IMPD). Responsibility for addressing clinical questions at meetings with regulatory authorities/ethics committees. Accountability for regulatory reporting requirements including Development Safety Update Reports (DSUR's) and IB updates. Incorporating patient perspective in the design and conduct of clinical studies. Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across all studies and other GSK activities/functions impacting safety and efficacy. Providing medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study.
Basic Qualifications & Skills:
We are looking for professionals with these required skills: Primary medical qualification (i.e. medical degree) and a clinical medical specialty qualification. Significant proven clinical or scientific expertise in rheumatology/dermatology/immunology. Industry or Academic experience in translational medicine and early/late phase drug development; experience of setting and executing scientific strategy. Understanding and knowledge of early/late drug development and translational sciences.
Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred; if you do not have them, please still apply: Primary medical qualification (i.e. medical degree) and PhD with a clinical medical specialty qualification (e.g., fellowship) in rheumatology/dermatology/immunology. Experience in working with relevant regulatory bodies and professionals in early/late-stage discovery and development. Project Management skills.
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.
Our success absolutely depends on our people. 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. 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.
#J-18808-Ljbffr
Site Name:
UK - Hertfordshire - Stevenage, UK - London - New Oxford Street Posted Date:
Nov 14 2024
Please note this role requires to be based in a UK GSK site for a minimum of 2 days per week.
Are you an Immunologist/Rheumatologist with a passion for developing new treatments for patients? This Medical Director role in our Respiratory & Immunology Research Unit (RIRU) may be of interest.
Our RIRU is committed to leading the way in Respiratory & Immunology Clinical Research, harnessing the power of the immune system, patient biology and predictive technologies. We are focused on bridging the gap between research and clinical practice to maximise pipeline value and enhance patient lives globally.
Key Responsibilities
The responsibilities of the Director Clinical Research and Early Programs Immunology include (but are not limited to):
Designing and leading clinical development protocols/studies/programs in Immunology across all phases of development, as required by business imperatives as part of clinical and medicine development matrix teams. Clinical development strategy including study Ph1-2/3 design. Providing clinical expert input into regulatory documentation and leading regulatory interactions from clinical perspective for their studies/indications, as appropriate. Working closely with Research Unit members to define prioritized clinical indications for early targets and integrate inputs from across disciplines (scientific, clinical, commercial, regulatory and stats) to contribute to the Medicine Profile, Target Validation, Translational Plans, Candidate Selection, clinical development plan and integrated evidence plan. Design and delivery of an early clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile to support progression to full development. Accountability for design and delivery of the full development clinical development plan that effectively demonstrates benefit-risk and leads to a successful submission to regulators, payors etc. Leading the integrated evidence planning to address the needs of regulators, payors, and patients. Participating/leading the clinical Team (CT) (or equivalent cross-functional clinical team) and Integrated Evidence Team (IET). Engaging external academic and clinical experts to enhance quality and delivery of clinical programs/studies. Providing clinical input into presentations and supporting documentation for governance bodies, as requested. Accountability for escalation of clinical safety incidents to the Immunology Clinical Research and Early Programs Head and GSK Pharmacovigilance, as appropriate. Clinical input to regulatory documentation to support the desired indication (e.g., IB, IMPD). Responsibility for addressing clinical questions at meetings with regulatory authorities/ethics committees. Accountability for regulatory reporting requirements including Development Safety Update Reports (DSUR's) and IB updates. Incorporating patient perspective in the design and conduct of clinical studies. Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across all studies and other GSK activities/functions impacting safety and efficacy. Providing medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study.
Basic Qualifications & Skills:
We are looking for professionals with these required skills: Primary medical qualification (i.e. medical degree) and a clinical medical specialty qualification. Significant proven clinical or scientific expertise in rheumatology/dermatology/immunology. Industry or Academic experience in translational medicine and early/late phase drug development; experience of setting and executing scientific strategy. Understanding and knowledge of early/late drug development and translational sciences.
Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred; if you do not have them, please still apply: Primary medical qualification (i.e. medical degree) and PhD with a clinical medical specialty qualification (e.g., fellowship) in rheumatology/dermatology/immunology. Experience in working with relevant regulatory bodies and professionals in early/late-stage discovery and development. Project Management skills.
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.
Our success absolutely depends on our people. 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. 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.
#J-18808-Ljbffr
