Clinical Development Director - Nephrology [3 DaysLeft]

You will need to login before you can apply for a job.Clinical Development Director - Nephrology Site Name: UK -Hertfordshire - Stevenage, UK - London - New Oxford Street PostedDate: Nov 15 2024 Please note this role requires to be based in aUK GSK site for a minimum of 2 days per week. Are you a NephrologyPhysician looking to partner with world renowned experts - bringingcutting edge science and technology to aid in the development ofnovel treatments for patients? This Director role in ourRespiratory & Immunology Research Unit (RIRU) may be ofinterest. Our RIRU is committed to leading the way in Respiratory& Immunology Clinical Research, harnessing the power of theimmune system, patient biology and predictive technologies. We arefocused on bridging the gap between research and clinical practiceto maximise pipeline value and enhance patient lives globally. AClinical Development Director - Nephrology is sought to provideclinical and scientific insights to the Nephrology franchiseincluding emerging indications and adjacencies. You will workwithin project teams to plan and assure delivery of clinicalresearch and development activities. You will work closely withresearch members to define the best clinical indication for atarget and integrate inputs from across disciplines (scientific,clinical, commercial, regulatory) to contribute to the EarlyMedicine Profile, Target Validation plans, and Candidate Selection.You will work with early and late development teams to planclinical development programs and facilitate close collaborationbetween diverse groups within the Respiratory & InflammationResearch Unit. The responsibilities of the Clinical DevelopmentDirector - Nephrology include (but are not limited to) several keyareas: - Designing and leading, as appropriate, clinicaldevelopment protocols/studies/programs in Nephrology across allphases of development, as required by business imperatives as partof clinical and medicine development matrix teams. - Clinicaldevelopment strategy including study Ph1-2/3 design - Providingclinical expert input into regulatory documentation and leadingregulatory interactions from clinical perspective for theirstudies/ indications, as appropriate - Working closely withResearch Unit members to define prioritized clinical indicationsfor early targets and integrate inputs from across disciplines(scientific, clinical, commercial, regulatory and stats) tocontribute to the Medicine Profile, Target Validation,Translational Plans, Candidate Selection, clinical development planand integrated evidence plan. - Design and delivery of an earlyclinical development plan that effectively demonstrates proof ofmechanism, potential efficacy, and a safety profile to supportprogression to full development - and/or accountability for designand delivery of the full development clinical development plan thateffectively demonstrates benefit-risk and leads to a successfulsubmission to regulators, payors etc. - Leading the integratedevidence planning to address the needs of regulators, payors, andpatients. - Participating/ leading the clinical Team (CT) (orequivalent cross-functional clinical team) and Integrated EvidenceTeam (IET) - Engaging external academic and clinical experts toenhance quality and delivery of clinical programs/ studies. -Providing clinical input into presentations, supportingdocumentation for and participation in the governance bodiespresentations, as requested. - Accountability for escalation ofclinical safety incidents to the Immunology Clinical Research andEarly Programs Head and GSK Pharmacovigilance, as appropriate -Clinical input to regulatory documentation to support the desiredindication (e.g., IB, IMPD) - Responsibility for addressingclinical questions at meetings with regulatory authorities/ethicscommittees - Accountability for regulatory reporting requirementsincluding Development Safety Update Reports (DSUR's) and IB updates- Accountable for incorporating patient perspective in the designand conduct of clinical studies - Medical Governance across theproject to ensure scientific integrity and overall safety of thestudy subjects across all studies and other GSKactivities/functions impacting safety and efficacy (i.e.,manufacturing, formulation, etc.) - Providing medical monitoringand oversight of the safety of study participants on behalf of theSponsor during the study and, together with the SafetyPharmacovigilance Physician, providing input into aspects of studydesign that relate to subject safety Leadership - Experience indrug development and/or translational medicine, preferably withindustry experience. - You will be expected to work across multipleprojects and be independently accountable for your own projects. -Provide input into disease area strategy and be capable ofexecuting this strategy based on your own expertise and that gainedfrom your network. - Play a leadership role in - medical governanceinitiatives in R&D (e.g., safety panel or governance board) -discovery/development policy, processes, or guidelines, asrequested by the business- or in professional networks in/outsideof GSK. - You will be able to input into relevant businessdevelopment activities representing, as requested. - Mentoring andcoaching other members of Clinical Research and Early ProgramsImmunology - applying extensive knowledge of clinical developmentto more than one research unit/disease area. - External networkingwith academia/pharma, bringing expertise back to GSK. - You will beable to anticipate, communicate, and suggest solutions ontrends/events outside GSK that affect our business direction -utilizing command of the drug discovery and development process toinfluence a culture of continuous improvement. Why you? BasicQualifications: We are looking for professionals with theserequired skills to achieve our goals: - Primary medicalqualification (i.e. medical degree) and a clinical medicalspecialty qualification - Significant proven clinical or scientificexpertise in nephrology - Industry or Academic experience intranslational medicine and early/late phase drug development;experience of setting and executing scientific strategy, whilstbeing mindful of overall goals - Understanding and knowledge ofearly/late drug development and translational sciences PreferredQualifications: 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 aclinical medical specialty qualification (e.g., fellowship) innephrology - Experience in working with relevant regulatory bodiesand professionals in early/late-stage discovery and development. -Project Management - Demonstrates the discipline of risk-basedplanning, organizing, and managing resources to bring about thesuccessful completion of specific project goals and objectives inaccordance with defined quality and time-based metrics. Why GSK?Uniting science, technology and talent to get ahead of diseasetogether. GSK is a global biopharma company with a special purpose- to unite science, technology and talent to get ahead of diseasetogether - so we can positively impact the health of billions ofpeople and deliver stronger, more sustainable shareholder returns -as an organisation where people can thrive. We prevent and treatdisease with vaccines, specialty and general medicines. We focus onthe science of the immune system and the use of new platform anddata technologies, investing in four core therapeutic areas(infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting aheadof disease together is about our ambition for patients andshareholders, it's also about making GSK a place where people canthrive. We want GSK to be a place where people feel inspired,encouraged and challenged to be the best they can be. A place wherethey can be themselves - feeling welcome, valued, and included.Where they can keep growing and look after their wellbeing. So, ifyou share our ambition, join us at this exciting moment in ourjourney to get Ahead Together. #J-18808-Ljbffr