Akebia Therapeutics ® , Inc.
Associate Medical Director, Clinical Research Cambridge, MA
Akebia Therapeutics ® , Inc., Cambridge, Maryland, United States, 21613
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.
Key Responsibilities:
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.
Contribute to and, with relevant experience, support the oversight of project-related education of investigators, study site personnel, and study staff.
Medical monitoring activities including but not limited to: review of medical listings, weekly and monthly coding review, review protocol deviations, and need for protocol amendments.
Support presentations at scientific, medical, and regulatory meetings globally.
Support the development and maintenance of relationships with investigators, pharmaceutical partners, vendors, key medical experts (KMEs), professional societies, and patient advocacy groups.
Support the provision of activities integral to INDs, NDAs, and other regulatory submissions such as authoring of clinical sections of related documents.
Partner with pharmacovigilance to assess the safety profile of compounds.
Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, KMEs, investigators, and internal stakeholders.
Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives.
Contribute to clinical development diligence or other business development activity.
Support research colleagues to design and implement translational strategies.
Basic Qualifications:
Medical Doctor (MD) or internationally recognized equivalent MD.
Preferred Qualifications:
Completion of a subspecialty fellowship in Nephrology, Cardiology, Endocrinology, or Hematology.
Nephrology therapeutic area knowledge preferred but not required.
Pharmaceutical drug development experience preferred.
Completion of an internship and residency strongly preferred.
Clinical trials experience desirable.
Evidence of fluency in oral and written 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; all 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. Akebians aren’t afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebians 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.
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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.
Key Responsibilities:
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.
Contribute to and, with relevant experience, support the oversight of project-related education of investigators, study site personnel, and study staff.
Medical monitoring activities including but not limited to: review of medical listings, weekly and monthly coding review, review protocol deviations, and need for protocol amendments.
Support presentations at scientific, medical, and regulatory meetings globally.
Support the development and maintenance of relationships with investigators, pharmaceutical partners, vendors, key medical experts (KMEs), professional societies, and patient advocacy groups.
Support the provision of activities integral to INDs, NDAs, and other regulatory submissions such as authoring of clinical sections of related documents.
Partner with pharmacovigilance to assess the safety profile of compounds.
Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, KMEs, investigators, and internal stakeholders.
Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives.
Contribute to clinical development diligence or other business development activity.
Support research colleagues to design and implement translational strategies.
Basic Qualifications:
Medical Doctor (MD) or internationally recognized equivalent MD.
Preferred Qualifications:
Completion of a subspecialty fellowship in Nephrology, Cardiology, Endocrinology, or Hematology.
Nephrology therapeutic area knowledge preferred but not required.
Pharmaceutical drug development experience preferred.
Completion of an internship and residency strongly preferred.
Clinical trials experience desirable.
Evidence of fluency in oral and written 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; all 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. Akebians aren’t afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebians 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