Senior Medical Director, Kidney Disease, Early Clinical Development CVRM
Are you an experienced physician with clinical expertise in the management of patients with kidney diseases and do you have well-developed clinical research experience? Would you like to be part of a talented and high peforming team of clinical research professionals, clinical scientists, and physicians who are translating rigorous scientific discoveries into early phase clinical development plans and clinical studies across a wide range of chronic and debilitating diseases?At AstraZeneca, we re dedicated to being a Great Place to Work with an inclusive and diverse team of talented colleagues who work in a solution-oriented, trusting, and collaborative work environment.
We are dedicated to improving the health care and quality of life for patients across a wide range of diseases and disorders by developing innovative therapies that address unment clinical needs and that provide clinicians with novel evidence-based treatment options that enable them to optimize the care of their patients.
Who We AreIn the Cardiovascular, Renal & Metabolism (CVRM) Early Clinical Development team, we are investigating the drivers of CVRM disease progression through ground breaking scientific methods and data-driven drug discovery approaches.
In this context, we are investigating a wide range of different drug modalities from our rich CVRM portfolio of componds across kidney disease patient populations.
Early Clinical Development (ECD), part of the Early CVRM organization, is where science meets clinical drug development with a focus upon delivering innovative, early phase clinical studies and accelerating human target validation while collaborating closely with our late phase clinical development and regulatory colleagues who guide our pivotal phase 3 clinical studies.
We are a diverse team of experienced physicians, clinical scientists, and clinical program directors who collaborate to delineate early phase clinical development strategies, design innovative phase I-IIb clinical trials, develop and validate novel surrogate endpoints, and translate scientific ideas to proof of concept studies in targeted patient populations.
We are recruiting a Senior Medical Director Physician, focused on Kidney Diseases - we will work on the full spectrum of kidney diseases and disorders, and related conditions that impact kidney function.
In this role, you will have the opportunity to work at the forefront of early clinical and translational research within CVRM.
In a multidisciplinary environment, you will play a key role in progressing a rich and diverse pipeline of both small and large molecules in numerous active clinical programs.
This is an office-based role that is located at AstraZeneca s vibrant R&D site in Gaithersburg, Maryland in the United States.
What you ll doYou will be responsible for managing and leading to early phase I-IIb global clinical trials and related clinical research projects for compounds that are targeting kidney disease, as well as serving as an expert on the design, conduct, monitoring, data interpretation, and reporting of these studies.
Additionally, you will work on cross-functional teams within our ECD group and across the broader early CVRM organization that are framing our strategies and development plans for compounds that are targeting cardiovascular diseases such as Heart Failure, as well as major metabolic disorders, such as Diabetes Mellitus, Obesity, and NASH, given that these disorders intersect with chronic kidney disease and influence disease progression.
In this role, you will contribute to and lead cross-functional project teams with multidisciplinary professionals from a diverse range of geographic locations.
We will rely on you to:
Contribute to and lead the design and operational implementation of early-stage clinical projects and ensure that all clinical programs under your purview are scientifically rigorous, are clinically sound and valid, are operationally successful, and adhere to Good Clinical Practice and regulatory requirementsCollaborate closely with other groups within the early CVRM therapeutic area to provide expert clinical input into pre-clinical scientific activities such as target selection, lead generation and optimization, clinical pharmacology, in vivo animal studies, in vitro studies, and drug formulation and manufacturingWork with a highly capable team of physicians and clinical scientists who design scientifically thorough, innovative, and efficient early phase clinical study protocols that are aligned with the pre-clinical scientific findings and clinical development plans for each compound, while ensuring seamless transition of early clinical programs to late stage developmentContribute to our interactions with regulatory authorities and governmental research organizations in the United States (such as the National Institutes of Health) related to our early phase clinical programs and studiesAssist with the preparation of various official and regulatory documents for Regulatory Authorities and other agencies, such as Dossiers, CTAs, INDs, Safety, and annual reportsContribute to our efforts to certify and validate the scientific evidence for non-clinical, surrogate endpoints used in our early phase kidney disease clinical studies including imaging and biomarker endpointsServe as an internal and external scientific expert to communicate and disseminate the scientific accomplishments of our early clinical development team through internal workshops and forums, presentations at scientific meetings, and scientific publicationsContribute to our interactions with key external clinical and scientific experts for kidney disease and translate input from external advisors into our clinical development plans, scientific discovery efforts, and regulatory interactionsContribute to our ongoing efforts to improve, enhance, and evole the operational planning and execution of our early phase kidney disease clinical studies, including developing innovative approaches for engaging and supporting clinical trial sites in the United States to perform well in our early phase clinical studiesEssential for the roleMust be a Medical Doctor, with a well-established clinical expertise in the treatment of kidney diseases.
Minimum of 7 years of clinical research experience either in the academic research environment OR in the pharmaceutical/biotechnology industry.
Must have well-developed interpersonal skills as well as a highly collaborative approach to the work that we do, including:
A robust clinical research experience and scientific publication recordEarly phase clinical translational research expertise, including experience in designing, monitoring, performing and interpreting early phase clinical trials and solid knowledge of biomarkers, surrogate endpoints, biostatistics, and safety reportingWhy AstraZeneca?Here, we need leadership at every level Physicians who not only have clinical and scientific expertise, but also the ability to build a case, engage multiple partners, and communicate effectively with different audiences.
With that kind of remit comes great responsibility.
We truly believe that everyone contributes with an outstanding set of competence.
Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximize your skills, abilities and contribution.
We offer competitive salary and excellent benefits, such as extra paid Holiday, Private Medical Benefits, On-site exercise and much, much more.
So, what s next? Are you already imagining yourself joining our team? Good, because we can t wait to hear from you.
Welcome to apply!Where can I find out more?AstraZeneca Gaithersburg:
CVRM at AstraZeneca:
Life at AstraZeneca :
Recent Publications:
Date Posted24-May-2023Closing Date31-May-2023AstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be.
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
SummaryLocation:
US - Gaithersburg - MDType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
We are dedicated to improving the health care and quality of life for patients across a wide range of diseases and disorders by developing innovative therapies that address unment clinical needs and that provide clinicians with novel evidence-based treatment options that enable them to optimize the care of their patients.
Who We AreIn the Cardiovascular, Renal & Metabolism (CVRM) Early Clinical Development team, we are investigating the drivers of CVRM disease progression through ground breaking scientific methods and data-driven drug discovery approaches.
In this context, we are investigating a wide range of different drug modalities from our rich CVRM portfolio of componds across kidney disease patient populations.
Early Clinical Development (ECD), part of the Early CVRM organization, is where science meets clinical drug development with a focus upon delivering innovative, early phase clinical studies and accelerating human target validation while collaborating closely with our late phase clinical development and regulatory colleagues who guide our pivotal phase 3 clinical studies.
We are a diverse team of experienced physicians, clinical scientists, and clinical program directors who collaborate to delineate early phase clinical development strategies, design innovative phase I-IIb clinical trials, develop and validate novel surrogate endpoints, and translate scientific ideas to proof of concept studies in targeted patient populations.
We are recruiting a Senior Medical Director Physician, focused on Kidney Diseases - we will work on the full spectrum of kidney diseases and disorders, and related conditions that impact kidney function.
In this role, you will have the opportunity to work at the forefront of early clinical and translational research within CVRM.
In a multidisciplinary environment, you will play a key role in progressing a rich and diverse pipeline of both small and large molecules in numerous active clinical programs.
This is an office-based role that is located at AstraZeneca s vibrant R&D site in Gaithersburg, Maryland in the United States.
What you ll doYou will be responsible for managing and leading to early phase I-IIb global clinical trials and related clinical research projects for compounds that are targeting kidney disease, as well as serving as an expert on the design, conduct, monitoring, data interpretation, and reporting of these studies.
Additionally, you will work on cross-functional teams within our ECD group and across the broader early CVRM organization that are framing our strategies and development plans for compounds that are targeting cardiovascular diseases such as Heart Failure, as well as major metabolic disorders, such as Diabetes Mellitus, Obesity, and NASH, given that these disorders intersect with chronic kidney disease and influence disease progression.
In this role, you will contribute to and lead cross-functional project teams with multidisciplinary professionals from a diverse range of geographic locations.
We will rely on you to:
Contribute to and lead the design and operational implementation of early-stage clinical projects and ensure that all clinical programs under your purview are scientifically rigorous, are clinically sound and valid, are operationally successful, and adhere to Good Clinical Practice and regulatory requirementsCollaborate closely with other groups within the early CVRM therapeutic area to provide expert clinical input into pre-clinical scientific activities such as target selection, lead generation and optimization, clinical pharmacology, in vivo animal studies, in vitro studies, and drug formulation and manufacturingWork with a highly capable team of physicians and clinical scientists who design scientifically thorough, innovative, and efficient early phase clinical study protocols that are aligned with the pre-clinical scientific findings and clinical development plans for each compound, while ensuring seamless transition of early clinical programs to late stage developmentContribute to our interactions with regulatory authorities and governmental research organizations in the United States (such as the National Institutes of Health) related to our early phase clinical programs and studiesAssist with the preparation of various official and regulatory documents for Regulatory Authorities and other agencies, such as Dossiers, CTAs, INDs, Safety, and annual reportsContribute to our efforts to certify and validate the scientific evidence for non-clinical, surrogate endpoints used in our early phase kidney disease clinical studies including imaging and biomarker endpointsServe as an internal and external scientific expert to communicate and disseminate the scientific accomplishments of our early clinical development team through internal workshops and forums, presentations at scientific meetings, and scientific publicationsContribute to our interactions with key external clinical and scientific experts for kidney disease and translate input from external advisors into our clinical development plans, scientific discovery efforts, and regulatory interactionsContribute to our ongoing efforts to improve, enhance, and evole the operational planning and execution of our early phase kidney disease clinical studies, including developing innovative approaches for engaging and supporting clinical trial sites in the United States to perform well in our early phase clinical studiesEssential for the roleMust be a Medical Doctor, with a well-established clinical expertise in the treatment of kidney diseases.
Minimum of 7 years of clinical research experience either in the academic research environment OR in the pharmaceutical/biotechnology industry.
Must have well-developed interpersonal skills as well as a highly collaborative approach to the work that we do, including:
A robust clinical research experience and scientific publication recordEarly phase clinical translational research expertise, including experience in designing, monitoring, performing and interpreting early phase clinical trials and solid knowledge of biomarkers, surrogate endpoints, biostatistics, and safety reportingWhy AstraZeneca?Here, we need leadership at every level Physicians who not only have clinical and scientific expertise, but also the ability to build a case, engage multiple partners, and communicate effectively with different audiences.
With that kind of remit comes great responsibility.
We truly believe that everyone contributes with an outstanding set of competence.
Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximize your skills, abilities and contribution.
We offer competitive salary and excellent benefits, such as extra paid Holiday, Private Medical Benefits, On-site exercise and much, much more.
So, what s next? Are you already imagining yourself joining our team? Good, because we can t wait to hear from you.
Welcome to apply!Where can I find out more?AstraZeneca Gaithersburg:
CVRM at AstraZeneca:
Life at AstraZeneca :
Recent Publications:
Date Posted24-May-2023Closing Date31-May-2023AstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be.
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
SummaryLocation:
US - Gaithersburg - MDType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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