Davita Inc.
Clinical Development Director
Davita Inc., Waltham, Massachusetts, United States, 02254
Site Name:
USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - London - New Oxford Street, USA - Massachusetts - Waltham, USA - North Carolina - DurhamPosted Date:
Oct 17 2024Are you energized by the opportunity to partner with key leaders in global medical science to accelerate business performance across and drive global operational support? If so, this Clinical Development Director opportunity could be an ideal opportunity to explore.I. Role PurposeThe Clinical Sciences Lead (CSL) is the single point accountability for the development of the scientific design, medical governance (if a physician) and interpretation of results of a study. The study designed is expected to fulfill a strategic objective of the clinical development or integrated evidence plan.II. Key AccountabilitiesSingle point of accountability for the following:Study DesignStudy design, including integrated input from internal/external experts, thought leaders, and patients.Study objectives are consistent with decision criteria in the CDP (i.e. ensuring Go/No-Go criteria has been set).Appropriate incorporation of design of study into protocol.PRF reviewed and approved clinical study proposal (CSP).Presenting the scientific rationale and study design at Investigator Meetings and responding to scientific questions arising from sites during study conduct.Scientific Oversight for the StudyBenefit risk of the study.Ensuring study analysis plan is aligned to objectives of the protocol and accountable for the clinical interpretation of study data and results.Clinical monitoring and ongoing review of clinical data and study conduct to assure patient safety and scientific integrity. This would include ongoing review of protocol deviations and implementation of remedial plans.Medical governance for the study
If a physician: Medical governance of study, including medical monitoring.If not a physician: The CSL is expected to delegate on a study physician, the medical governance accountability and interface closely with her/him for advisory information on benefit risk.
Evidence Generation & Outputs for the StudyInterpretation of study data to create the scientific content of Clinical Study Report (CSR).Preparation of study results for abstracts, posters, and presentations for scientific meetings, congresses, external journal publications.Preparation of clinical content of regulatory documents and interaction with global regulatory authorities for the study.Provides input into and reviews other relevant study documents including the informed consent (ICF), protocol deviation management plan (PDMP), study reference manual (SRM).Provides scientific content for other study specific documentation (e.g. slides for site/monitor/investigator training).Study Level CollaborationPartner with the Study Delivery Lead to ensure optimal delivery of the study.Maintaining close collaboration with various functions including: drug safety, regulatory affairs, medical affairs, and clinical trial operations at the study level.III. Core CompetenciesStrategic assessment and decision making when designing clinical studies.Interfaces with relevant scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical studies.Embraces challenge as an opportunity for creativity and uses new learning and digital tools to create innovation in other areas.Embraces creative thinking and coming up with innovative business solutions.Solid understanding of clinical research and biostatistics principles, to facilitate innovative and efficient clinical trial design, that supports the clinical development plan with clear data-driven decision rules.Uses sound judgment, statistics, and visualization techniques to interpret or analyze moderately complex information and make correct inferences and conclusions. Analyses, interprets, and critically evaluates data, information, and digital content.Ability to respond with confidence to more complex questions using sound judgment.Awareness of the importance of work undertaken in support of the medicine vision and lifecycle management plan.Demonstrated experience contributing to projects and working collaboratively with multiple stakeholders.Ability to research and use data from a range of sources to make robust fact-based decisions, employing diverse and critical thinking.Experience leading line or matrix teams at the study level.Why you?Basic Qualifications:Bachelor's degree in a science-related field (Infectious Disease preferred).Experience participating in global initiatives.Experience managing large programs.Preferred Qualifications:Advanced Degree (MS, PhD, MD).Demonstrated leadership success and record of high performance and delivery.Experience of change management and leading teams through change.Why GSK?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 organization 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.
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USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - London - New Oxford Street, USA - Massachusetts - Waltham, USA - North Carolina - DurhamPosted Date:
Oct 17 2024Are you energized by the opportunity to partner with key leaders in global medical science to accelerate business performance across and drive global operational support? If so, this Clinical Development Director opportunity could be an ideal opportunity to explore.I. Role PurposeThe Clinical Sciences Lead (CSL) is the single point accountability for the development of the scientific design, medical governance (if a physician) and interpretation of results of a study. The study designed is expected to fulfill a strategic objective of the clinical development or integrated evidence plan.II. Key AccountabilitiesSingle point of accountability for the following:Study DesignStudy design, including integrated input from internal/external experts, thought leaders, and patients.Study objectives are consistent with decision criteria in the CDP (i.e. ensuring Go/No-Go criteria has been set).Appropriate incorporation of design of study into protocol.PRF reviewed and approved clinical study proposal (CSP).Presenting the scientific rationale and study design at Investigator Meetings and responding to scientific questions arising from sites during study conduct.Scientific Oversight for the StudyBenefit risk of the study.Ensuring study analysis plan is aligned to objectives of the protocol and accountable for the clinical interpretation of study data and results.Clinical monitoring and ongoing review of clinical data and study conduct to assure patient safety and scientific integrity. This would include ongoing review of protocol deviations and implementation of remedial plans.Medical governance for the study
If a physician: Medical governance of study, including medical monitoring.If not a physician: The CSL is expected to delegate on a study physician, the medical governance accountability and interface closely with her/him for advisory information on benefit risk.
Evidence Generation & Outputs for the StudyInterpretation of study data to create the scientific content of Clinical Study Report (CSR).Preparation of study results for abstracts, posters, and presentations for scientific meetings, congresses, external journal publications.Preparation of clinical content of regulatory documents and interaction with global regulatory authorities for the study.Provides input into and reviews other relevant study documents including the informed consent (ICF), protocol deviation management plan (PDMP), study reference manual (SRM).Provides scientific content for other study specific documentation (e.g. slides for site/monitor/investigator training).Study Level CollaborationPartner with the Study Delivery Lead to ensure optimal delivery of the study.Maintaining close collaboration with various functions including: drug safety, regulatory affairs, medical affairs, and clinical trial operations at the study level.III. Core CompetenciesStrategic assessment and decision making when designing clinical studies.Interfaces with relevant scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical studies.Embraces challenge as an opportunity for creativity and uses new learning and digital tools to create innovation in other areas.Embraces creative thinking and coming up with innovative business solutions.Solid understanding of clinical research and biostatistics principles, to facilitate innovative and efficient clinical trial design, that supports the clinical development plan with clear data-driven decision rules.Uses sound judgment, statistics, and visualization techniques to interpret or analyze moderately complex information and make correct inferences and conclusions. Analyses, interprets, and critically evaluates data, information, and digital content.Ability to respond with confidence to more complex questions using sound judgment.Awareness of the importance of work undertaken in support of the medicine vision and lifecycle management plan.Demonstrated experience contributing to projects and working collaboratively with multiple stakeholders.Ability to research and use data from a range of sources to make robust fact-based decisions, employing diverse and critical thinking.Experience leading line or matrix teams at the study level.Why you?Basic Qualifications:Bachelor's degree in a science-related field (Infectious Disease preferred).Experience participating in global initiatives.Experience managing large programs.Preferred Qualifications:Advanced Degree (MS, PhD, MD).Demonstrated leadership success and record of high performance and delivery.Experience of change management and leading teams through change.Why GSK?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 organization 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.
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