GSK
Clinical Development Director
GSK, Waltham, Massachusetts, us, 02453
Are 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.
The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.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 patientsStudy 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 conductScientific Oversight for the StudyBenefit risk of the studyEnsuring study analysis plan is aligned to objectives of the protocol and accountable for the clinical interpretation of study data and resultsClinical 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 plansMedical governance for the study
If a physician: Medical governance of study, including medical monitoringIf 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 publicationsPreparation of clinical content of regulatory documents and interaction with global regulatory authorities for the studyProvides input into and reviews other relevant study document 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)4) Study Level CollaborationPartner with the Study Delivery Lead to ensure optimal delivery of the studyMaintaining close collaboration with various functions including: drug safety, regulatory affairs, medical affairs and clinical trial operations at the study levelIII Core CompetenciesStrategic assessment and decision making when designing clinical studiesInterfaces relevant scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical studiesEmbraces challenge as an opportunity for creativity and uses new learning and digital tools to create innovation in other areasEmbraces creative thinking and coming up with innovative business solutionsSolid 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 rulesUses 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 contentAbility to respond with confidence to more complex questions using sound judgmentAwareness of the importance of work undertaken in support of the medicine vision and lifecycle management planDemonstrated experience contributing projects and working collaboratively with multiple stakeholdersAbility to research and use data from a range of sources to make robust fact-based decisions, employing diverse and critical thinkingExperience leading line or matrix teams at the study levelWhy you?Basic Qualifications:We are looking for professionals with the required skills to achieve our goals:Bachelor's degree in a science related field (Infectious Disease preferred)Experience participating in above global initiativesExperience managing large programsPreferred Qualifications:If you have the following characteristics, it would be a plus:Advanced Degree (MS, PhD, MD)Demonstrated leadership success and record of high performance and deliveryExperience of change management and leading teams through changeWhy GSK?
Our values and expectations
are at the heart of everything we do and form an important part of our culture.These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.Managing individual and team performance.Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.Implementing change initiatives and leading change.Sustaining energy and well-being, building resilience in teams.Continuously looking for opportunities to learn, build skills and share learning both internally and externally.Developing people and building a talent pipeline.Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.Budgeting and forecasting, commercial and financial acumen.#LI-GSKPlease 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 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.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.PDN-9d4cae4b-92b1-4701-a863-56fa8902384d
The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.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 patientsStudy 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 conductScientific Oversight for the StudyBenefit risk of the studyEnsuring study analysis plan is aligned to objectives of the protocol and accountable for the clinical interpretation of study data and resultsClinical 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 plansMedical governance for the study
If a physician: Medical governance of study, including medical monitoringIf 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 publicationsPreparation of clinical content of regulatory documents and interaction with global regulatory authorities for the studyProvides input into and reviews other relevant study document 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)4) Study Level CollaborationPartner with the Study Delivery Lead to ensure optimal delivery of the studyMaintaining close collaboration with various functions including: drug safety, regulatory affairs, medical affairs and clinical trial operations at the study levelIII Core CompetenciesStrategic assessment and decision making when designing clinical studiesInterfaces relevant scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical studiesEmbraces challenge as an opportunity for creativity and uses new learning and digital tools to create innovation in other areasEmbraces creative thinking and coming up with innovative business solutionsSolid 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 rulesUses 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 contentAbility to respond with confidence to more complex questions using sound judgmentAwareness of the importance of work undertaken in support of the medicine vision and lifecycle management planDemonstrated experience contributing projects and working collaboratively with multiple stakeholdersAbility to research and use data from a range of sources to make robust fact-based decisions, employing diverse and critical thinkingExperience leading line or matrix teams at the study levelWhy you?Basic Qualifications:We are looking for professionals with the required skills to achieve our goals:Bachelor's degree in a science related field (Infectious Disease preferred)Experience participating in above global initiativesExperience managing large programsPreferred Qualifications:If you have the following characteristics, it would be a plus:Advanced Degree (MS, PhD, MD)Demonstrated leadership success and record of high performance and deliveryExperience of change management and leading teams through changeWhy GSK?
Our values and expectations
are at the heart of everything we do and form an important part of our culture.These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.Managing individual and team performance.Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.Implementing change initiatives and leading change.Sustaining energy and well-being, building resilience in teams.Continuously looking for opportunities to learn, build skills and share learning both internally and externally.Developing people and building a talent pipeline.Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.Budgeting and forecasting, commercial and financial acumen.#LI-GSKPlease 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 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.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.PDN-9d4cae4b-92b1-4701-a863-56fa8902384d