Akebia Therapeutics
Associate Medical Director, Clinical Research
Akebia Therapeutics, Cambridge, Massachusetts, us, 02140
Associate Medical Director, Clinical Research
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Clinical --> Clinical Development
Cambridge, MA*
ID:
24R-20
*Full-Time/Regular
Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.
At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.
This is life-changing work, and we are all in, are you?
The Clinical development department is responsible for the medical aspects of development activities, including clinical development plans (CDP) and clinical trials.The Associate Medical Director will contribute to the direction, planning, execution, and medical oversight of clinical trials and aligned research activities for one or more clinical development programs.Additionally, he/she will be involved to a varying degree in the analysis and interpretation of data outputs.He/she participates in cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.
Contribute to and as appropriate support the implementation of a clinical development program or programs as part of the overall product development plan, based on sound medical and scientific principles.
Contributetoand,withrelevantexperience,supporttheoversightof project-relatededucation of investigators, study site personnel, and study staff
Medicalmonitoringactivitiesincludingbutnotlimitedto:review
ofmedicallistings,weeklyand monthly coding review, review protocol deviations, and need for protocol amendments
Supportpresentationsatscientific,medical,andregulatorymeetings globally
Supportthedevelopmentandmaintenanceofrelationshipswithinvestigators,pharmaceutical partners, vendors, key medical experts KMEs, professional societies, and patient advocacy
groups
SupporttheprovisionofactivitiesintegraltoINDs,NDAsandotherregulatorysubmissions such as authoring of clinical sections of related documents
Partnerwithpharmacovigilancetoassessthesafetyprofileof compounds
Maintainahighlevelofclinicalandscientificexpertiseinthediseasearea(s)byreviewingthe literature, attending medical/scientific meetings, and through personal interchanges with consultants, KMEs, investigators and internal stakeholders
Authormanuscriptsandcollaboratewithcross-functionalcolleaguesandthoughtleadersto meet publication plan objectives
Contribute to clinical development diligence or other business development activity
Support research colleagues to the design and implement translational strategies
Basic Qualifications:
MedicalDoctor(MD)or
internationally recognized equivalent
MD
Preferred Qualifications:
Completion of a subspeciality fellowship in Nephrology, Cardiology, Endocrinology or Hematology
Nephrology therapeutic area knowledge preferred but not required
Pharmaceuticaldrugdevelopmentexperience preferred
Completionofaninternshipandresidencystrongly preferred
Clinicaltrialsexperience desirable
Evidenceoffluencyinoralandwritten communication
Compensation:
Targeted Base: 169706 - 241832*
*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, a
ll regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.
Are you an Akebian?
An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website:
www.akebia.com
COVID 19 Vaccination:
All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Akebia will consider, among other things whether a proposed accommodation would create an undue hardship. Please note that it is unlikely that accommodations can be granted for customer-facing positions.
Akebia is an equal opportunity employer and welcomes all job applicants.
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
#J-18808-Ljbffr
LinkedInTwitterEmailMessageShare
Clinical --> Clinical Development
Cambridge, MA*
ID:
24R-20
*Full-Time/Regular
Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.
At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.
This is life-changing work, and we are all in, are you?
The Clinical development department is responsible for the medical aspects of development activities, including clinical development plans (CDP) and clinical trials.The Associate Medical Director will contribute to the direction, planning, execution, and medical oversight of clinical trials and aligned research activities for one or more clinical development programs.Additionally, he/she will be involved to a varying degree in the analysis and interpretation of data outputs.He/she participates in cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.
Contribute to and as appropriate support the implementation of a clinical development program or programs as part of the overall product development plan, based on sound medical and scientific principles.
Contributetoand,withrelevantexperience,supporttheoversightof project-relatededucation of investigators, study site personnel, and study staff
Medicalmonitoringactivitiesincludingbutnotlimitedto:review
ofmedicallistings,weeklyand monthly coding review, review protocol deviations, and need for protocol amendments
Supportpresentationsatscientific,medical,andregulatorymeetings globally
Supportthedevelopmentandmaintenanceofrelationshipswithinvestigators,pharmaceutical partners, vendors, key medical experts KMEs, professional societies, and patient advocacy
groups
SupporttheprovisionofactivitiesintegraltoINDs,NDAsandotherregulatorysubmissions such as authoring of clinical sections of related documents
Partnerwithpharmacovigilancetoassessthesafetyprofileof compounds
Maintainahighlevelofclinicalandscientificexpertiseinthediseasearea(s)byreviewingthe literature, attending medical/scientific meetings, and through personal interchanges with consultants, KMEs, investigators and internal stakeholders
Authormanuscriptsandcollaboratewithcross-functionalcolleaguesandthoughtleadersto meet publication plan objectives
Contribute to clinical development diligence or other business development activity
Support research colleagues to the design and implement translational strategies
Basic Qualifications:
MedicalDoctor(MD)or
internationally recognized equivalent
MD
Preferred Qualifications:
Completion of a subspeciality fellowship in Nephrology, Cardiology, Endocrinology or Hematology
Nephrology therapeutic area knowledge preferred but not required
Pharmaceuticaldrugdevelopmentexperience preferred
Completionofaninternshipandresidencystrongly preferred
Clinicaltrialsexperience desirable
Evidenceoffluencyinoralandwritten communication
Compensation:
Targeted Base: 169706 - 241832*
*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, a
ll regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.
Are you an Akebian?
An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website:
www.akebia.com
COVID 19 Vaccination:
All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Akebia will consider, among other things whether a proposed accommodation would create an undue hardship. Please note that it is unlikely that accommodations can be granted for customer-facing positions.
Akebia is an equal opportunity employer and welcomes all job applicants.
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
#J-18808-Ljbffr