Are you energized by an opportunity to accelerate and deliver clinical safety and compliance across multiple clinical programs? If so, this Clinical Development Manager role could be an exciting opportunity to explore.
As a Clinical Development Manager, you will participate in Phase I-IV Clinical Development and Epidemiology activities within a program or group of related programs to ensure the high quality and on-time delivery of scientific data.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
* Participate in Clinical Development and Epidemiology activities for a study or studies within a specific program or group of related programs.
* Design clinical trial and epidemiology study protocols, and author study reports and publications of high scientific, operational and ethical standards under the supervision of an experienced senior Clinical Research Development Lead (CRDL), senior Epidemiologist or Clinical Epidemiology Program Lead (CEPL).
* Responsible for scientific and medical quality and timeliness of clinical trial synopses and protocols and all clinical trial documents, including Investigator’s Brochure and the Study Report.
* Supervise the study conduct and serve as the accountable for the overall delivery of clinical and epidemiology trials and as a scientific and management reference for the project (internally/externally).
* Support the Senior CRDL, Senior Epidemiologist or CEPL in representing therapy area in meetings with health authorities and the scientific community where applicable.
* Assemble and transmit timely summaries of clinical safety data for review by the competent medical officer and publish clinical and epidemiology data in peer review journals and presents in external scientific meetings/congresses.
* Responsible for Data Listing review for the medical portion of data listing for individual studies and assuring medical consistency within a trial and across trials within program.
* Address scientific and medical issues related to one or more clinical/epidemiology studies paying special attention to serious adverse events and potential safety signals and ensures study results meet the highest standards of quality and ethical conduct.
* Liaise with the Regional Evidence Generation and the Local Medical Leads to ensure alignment of clinical/ epidemiology trial activities (includes but not limited to, scientific and medical issues as well as subjects safety).
* Actively participate in preparing the clinical portion of the regulatory files and the registration process and contributes to development of clinical section of regulatory files, including labelling.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
* At least 1-year of direct experience with Good Clinical Practices (GCP), Good Epidemiology Practice (GEP), regulatory guidelines
* At least 1-year of experience overseeing the medical and human safety aspects of clinical programs
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
* PhD or Doctor of Medicine (MD)
* Experience independently conducting clinical research, critically evaluating scientific aspects of immunology
* Ability to work in matrix environment and multi-task through good planning and organization skills
* Effective ability to prioritize tasks and deliver on deadlines
* Ability to translate scientific skills in clinical research into business-driven strategies
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Please visit GSK US Benefits Summary t o 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. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
GSK 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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
About the company
GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England.
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