Associate Medical Director

Akebia Therapeutics; Waltham (MA); Hybrid; USD 220.000 - 272.000; Vollzeit

Benefits dieser Stelle

Health care

Vision insurance

Dental insurance

Retirement plan

Paid time off

Zusammenfassung

Akebia Therapeutics, Inc. is seeking an Associate Medical Director in the Clinical Development department to contribute to direction, planning, and medical oversight of clinical trials for one or more programs.

The role involves data interpretation, cross-functional collaboration, and regulatory support in a hybrid work environment based in Waltham, MA. The successful candidate will lead medical monitoring, support investigator education, and participate in regulatory submissions while

Qualifikationen

• Medical Doctor (MD) is required.
• Ability to critically evaluate and interpret clinical and scientific data.
• Strong written and verbal communication skills.
• Ability to work effectively in a cross-functional, collaborative environment.
• Strong organizational skills and ability to manage multiple priorities.

Aufgaben

• Develop and execute clinical development strategies aligned with program goals.
• Review and implement trial protocols and related study documents.
• Collaborate with Clinical Operations and study teams to support trial execution and address medical issues.
• Oversee education of investigators and site personnel.
• Medical monitoring activities including review of listings and protocol deviations.
• Support presentations at scientific, medical, and regulatory meetings.
• Maintain relationships with investigators, vendors, KMEs, societies, and patient groups.
• Assist in regulatory submissions such as INDs/NDAs and related documents.
• Partner with pharmacovigilance to assess safety profiles of compounds.
• Stay current with literature and meetings to maintain expertise.
• Author manuscripts and collaborate with thought leaders to meet publication plans.
• Ensure activities comply with GCP and company policies.

Kenntnisse

Clinical development

Data interpretation

Strong communication

Cross-functional teamwork

Organizational skills

Ausbildung

Medical Doctor (MD)

Jobbeschreibung

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?

Please note that our offices have recently relocated to Waltham, MA. We follow a flexible, “magnet not mandate” approach to in-office work, encouraging in-person collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs.

Job Summary:

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.

Essential Functions & Duties

• Contribute to the development and execution of clinical development strategies and plans in alignment with program objectives.
• Impact the development, review, and implementation of clinical trial protocols and related study documents.
• Collaborate with Clinical Operations and study teams to support successful study execution and address medical and scientific issues that arise during clinical trials.
• Support and add to 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, , 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
• Ensure clinical development activities are conducted in accordance with applicable regulations, Good Clinical Practice (GCP), company policies, and ethical standards.

Skills & Experience

Required Qualifications

• Medical Doctor (MD), or non-US equivalent of MD
• Ability to critically evaluate and interpret clinical and scientific data.
• Strong written and verbal communication skills.
• Ability to work effectively in a cross-functional, collaborative environment.
• Strong organizational skills and ability to manage multiple priorities in a dynamic environment.
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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.

$220,074 - $271,856 USD

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

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.

Selecting “no” will not eliminate you from consideration for this role.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Akebia Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

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