Associate Medical Director, Clinical Development (Hybrid)

Akebia Therapeutics, Inc.; Waltham (MA); Hybrid; USD 220,000 - 272,000; Full time

Benefits offered by this job

Health care

Vision insurance

Dental insurance

Retirement plan

Paid time off

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Clinical development

Data interpretation

Strong communication

Cross-functional teamwork

Organizational skills

Education

Medical Doctor (MD)

Job description

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