Associate Medical Director, Clinical Research

at  Akebia Therapeutics

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.
• 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 the design and implement translational strategies

BASIC QUALIFICATIONS:

• Medical Doctor (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
• 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

• 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 the design and implement translational strategie