GlaxoSmithKline
Clinical Development Manager, Oncology
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
Site Name:
Cambridge MA, GSK HQ, UK - Hertfordshire - Stevenage, Upper Providence, Warsaw Rzymowskiego 53Posted Date:
Nov 15 2024This role within Global Clinical Oncology R&D will serve as a clinical sciences leader on global oncology studies and contribute to program-level activities. Responsible for the delivery of quality study strategy and design, understanding the analysis and interpretation of data throughout the study, including leading clinical data review ongoing throughout study conduct. Responsible for the end to end of writing protocols (protocol concept to final study report) delivery. Contributor to informed consent forms development and other study related documents.Clinical Development OncologyKey Responsibilities:Review and/or enhance the technical and scientific robustness of project level clinical development plans.
May support regulatory interactions, including contributing to briefing documents, presentations, addressing questions and responses.
Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
Contribute to development of end-to-end clinical development strategy.
Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.
Actively partner to build relationships and collaborate with oncology aligned staff in other global functions.
Responsible for cultivating strong relationships and robust communication among the clinical study/project team and GSK's Oncology Clinical Development Organization. This includes training, education, onboarding as well as problem solving in the conduct of clinical trials.
Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
Study design and interpretation of study results that provide data to adequately address questions concerning efficacy/effectiveness, safety, applicability to targeted patient population, and clinical and commercial value that are consistent with the compounds' phase of development while ensuring that patient safety is of paramount concern and that regulatory requirements are incorporated through:
Accountability for Study Team members/stakeholders, as appropriate and regulatory reporting at the study level by providing leadership at study level to assure overall safety of the study subjects.
Drive/Contributing to clinical components of the IB, and documents for regulatory submissions and advisory requirements, including scientific advice, IND, EoP2, preNDA/BLA meetings, NDA/BLA and MAA documents.
Serves as a product, protocol and project subject matter expert to support internal and external customers.
Work with external experts to develop abstracts, manuscripts and study design presentations.
Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Bachelor's degree in life sciences or related discipline with 3+ years of relevant experience
Experience in a pharmaceutical industry or CRO environment in the clinical development process
Experience with study management, global regulatory guidelines and ICH/GCP
Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports
Preferred Qualifications:If you have the following characteristics, it would be a plus:Advanced degree (e.g. MS, PhD, PharmD)
Clinical development experience across all phases of development (I-IV).
Oncology clinical development experience, particularly in the area of immuno-oncology
Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors (moved from required)
Excellent leadership skills (moved from required)
Excellent influencing and negotiation skills
Please 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.
Cambridge MA, GSK HQ, UK - Hertfordshire - Stevenage, Upper Providence, Warsaw Rzymowskiego 53Posted Date:
Nov 15 2024This role within Global Clinical Oncology R&D will serve as a clinical sciences leader on global oncology studies and contribute to program-level activities. Responsible for the delivery of quality study strategy and design, understanding the analysis and interpretation of data throughout the study, including leading clinical data review ongoing throughout study conduct. Responsible for the end to end of writing protocols (protocol concept to final study report) delivery. Contributor to informed consent forms development and other study related documents.Clinical Development OncologyKey Responsibilities:Review and/or enhance the technical and scientific robustness of project level clinical development plans.
May support regulatory interactions, including contributing to briefing documents, presentations, addressing questions and responses.
Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
Contribute to development of end-to-end clinical development strategy.
Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.
Actively partner to build relationships and collaborate with oncology aligned staff in other global functions.
Responsible for cultivating strong relationships and robust communication among the clinical study/project team and GSK's Oncology Clinical Development Organization. This includes training, education, onboarding as well as problem solving in the conduct of clinical trials.
Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
Study design and interpretation of study results that provide data to adequately address questions concerning efficacy/effectiveness, safety, applicability to targeted patient population, and clinical and commercial value that are consistent with the compounds' phase of development while ensuring that patient safety is of paramount concern and that regulatory requirements are incorporated through:
Accountability for Study Team members/stakeholders, as appropriate and regulatory reporting at the study level by providing leadership at study level to assure overall safety of the study subjects.
Drive/Contributing to clinical components of the IB, and documents for regulatory submissions and advisory requirements, including scientific advice, IND, EoP2, preNDA/BLA meetings, NDA/BLA and MAA documents.
Serves as a product, protocol and project subject matter expert to support internal and external customers.
Work with external experts to develop abstracts, manuscripts and study design presentations.
Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Bachelor's degree in life sciences or related discipline with 3+ years of relevant experience
Experience in a pharmaceutical industry or CRO environment in the clinical development process
Experience with study management, global regulatory guidelines and ICH/GCP
Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports
Preferred Qualifications:If you have the following characteristics, it would be a plus:Advanced degree (e.g. MS, PhD, PharmD)
Clinical development experience across all phases of development (I-IV).
Oncology clinical development experience, particularly in the area of immuno-oncology
Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors (moved from required)
Excellent leadership skills (moved from required)
Excellent influencing and negotiation skills
Please 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.