Associate Medical Director

Akebia Therapeutics•Waltham, MA

10h•Hybrid

About The Position

The Clinical Development department is responsible for the medical aspects of development activities, including clinical development plans and clinical trials. The Associate Medical Director contributes to the direction, planning, execution, and medical oversight of clinical trials and aligned research activities for one or more clinical development programs. The role also involves analysis and interpretation of data outputs and participation in cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting product scientific and business strategy. The position supports clinical development strategy and plans, clinical trial protocols and study documents, study execution, medical monitoring, investigator and study personnel education, scientific and regulatory presentations, regulatory submissions, pharmacovigilance activities, and publication objectives. The role maintains clinical and scientific expertise in relevant disease areas and ensures development activities comply with regulations, Good Clinical Practice, company policies, and ethical standards. Akebia’s offices are in Waltham, Massachusetts. The company uses 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.

Requirements

Medical Doctor (MD) or non-US equivalent of an 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.

Responsibilities

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 arising during clinical trials.
Support oversight of project-related education for investigators, study site personnel, and study staff.
Conduct medical monitoring activities, including reviewing medical listings and protocol deviations and assessing the need for protocol amendments.
Support presentations at global scientific, medical, and regulatory meetings.
Support the development and maintenance of relationships with investigators, pharmaceutical partners, vendors, key medical experts, professional societies, and patient advocacy groups.
Support activities integral to INDs, NDAs, and other regulatory submissions, including authoring clinical sections of related documents.
Partner with pharmacovigilance to assess the safety profile of compounds.
Maintain clinical and scientific expertise in relevant disease areas by reviewing literature, attending scientific and medical meetings, and engaging with consultants, key medical experts, investigators, and internal stakeholders.
Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives.
Ensure clinical development activities comply with applicable regulations, Good Clinical Practice, company policies, and ethical standards.