Director, Medical Director, Clinical Research

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?

Job Summary

The Clinical Development department is responsible for the medical aspects of development activities, encompassing clinical development plans (CDPs) and clinical trials. The Medical Director is tasked with providing direction, planning, execution, medical oversight, and interpretation of clinical trials or research activities for one or more clinical development programs. They may also lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data, contributing to the overall product scientific and business strategy.

Essential Functions & Duties

• Lead the implementation of clinical development programs aligned with the company's overall developmental strategy. Apply strong medical and scientific knowledge, including understanding of compliance and regulatory requirements, to provide crucial clinical input throughout the development process.
• Develop and deliver project-related education for investigators, study site personnel, and study staff.
• Serve as the primary medical point of contact for assigned projects or studies.
• Direct medical monitoring, effectively managing medical and safety reviews, processes, and projects for assigned development programs and clinical studies.
• Proactively contribute to and lead clinical study teams, ensuring overall study integrity through the review, interpretation, and dissemination of safety and efficacy data.
• Collaborate with Clinical Operations on the initiation and conduct of clinical trials, and partner with other functional areas to prepare clinical development plans, protocols, investigator brochures, clinical study reports, manuscripts, and scientific presentations.
• Proactively engage with CROs and other service providers to enhance communication, including providing guidance on patient eligibility and ongoing protocol management.
• Present findings at scientific, medical, and regulatory meetings.
• Cultivate and maintain relationships with academic investigators, pharmaceutical partners/sponsors, key medical experts (KMEs), and patient advocacy groups.
• Contribute to key activities supporting planned regulatory submissions, including authoring clinical sections for INDs and other regulatory documents.
• Collaborate with pharmacovigilance to assess the safety profile of compounds.
• Maintain advanced clinical and scientific expertise in relevant disease areas through literature review, attendance at medical/scientific meetings, and interactions with consultants, KMEs, investigators, and internal stakeholders.
• Review and author manuscripts and collaborate with cross-functional colleagues and KMEs to achieve publication plan objectives.
• Adhere to the highest ethical standards and comply with all relevant ethical, regulatory, and legal standards.
• Participate in or lead clinical development contributions to due diligence or other business development activities, as appropriate.
• Contribute to the design and implementation of translational strategies in partnership with Discovery colleagues, as required by program needs.

Basic Qualifications

• Medical Doctor (M.D.), or equivalent international medical degree.

Preferred Qualifications

• Experience in pharmaceutical drug development.
• Completion of a medical residency program.
• Completion of a sub-specialty fellowship.
• Clinical experience in Nephrology, Cardiology, and/or Hematology.
• Experience supporting NDA and/or global regulatory submissions (not required for candidates new to industry).
• Demonstrated ability to independently manage complex clinical research programs or contribute effectively as part of a team.
• Comprehensive knowledge of clinical trial methodology (industry or academic) and relevant regulatory and compliance requirements.
• Experience developing clinical strategies and designing study protocols.
• Proven leadership skills with the ability to foster collaboration and excellence within cross-functional global teams.

Compensation

Targeted Base: $259,786 - $320,912*

*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. 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 characteristics protected by applicable law.