Associate Director/Director, Clinical Trial Management

Acumen Pharmaceuticals, Inc.

Associate Director/Director responsible for clinical trial management, ensuring quality and execution in a biopharmaceutical setting. Overseeing operational strategy, vendor oversight, and site management.

Posted 4/13/2026full-timeNewton • Massachusetts • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

The Associate Director/Director, Clinical Trial Management, is responsible for the oversight of the operational planning, execution, and delivery of one or more clinical studies.
Ensure quality, timelines, budget, and inspection readiness in accordance with ICH‑GCP, applicable regulations, and Standard Operating Procedures (SOPs).
In collaboration with Clinical Operations lead, lead operational management of assigned clinical studies from protocol synopsis through study close‑out.
Develop and own the operational strategy and study execution plans.
Chair cross‑functional Study Management Team meetings, drive decision‑making, and ensure clear communication of goals, risks, and mitigations to internal and external stakeholders.
Provide oversight of CROs and key vendors.
Oversee site feasibility, selection, activation, and performance, ensuring recruitment and retention targets are achieved.
Ensure trial activities are conducted per protocol, Good Clinical Practice (GCP), local regulations, company SOPs, and inspection‑readiness standards.
Manage study timelines, critical path, and key performance indicators; proactively identify risks and implement mitigation and contingency plans.
Provide regular study status updates to Clinical Operations leadership, program leadership and/or senior management.

Requirements

What you’ll need

Bachelor’s degree in life sciences, nursing, pharmacy or related field.
A minimum of 10 years of clinical research/clinical operations experience, including significant experience as a Clinical Trial Manager or equivalent; prior global study leadership and clinical trial experience in CNS strongly preferred.
Demonstrated experience managing phase 1–3 interventional clinical trials, including vendor/CRO oversight and global site management.
Previous experience in resource and people management.
Deep knowledge of ICH‑GCP, relevant regulatory requirements, and clinical trial processes from start‑up to closure.
Proven ability to manage complex timelines and budgets and to lead in a matrix, cross‑functional environment.
Strong leadership, communication, and negotiation skills.
Proficiency with clinical trial systems (e.g., CTMS, eTMF, EDC) and Microsoft Office tools.

Benefits

Comp & perks

Competitive base salary, eligibility for an annual incentive bonus and eligibility to participate in company stock option plan.
Competitive benefits package including health, dental, vision, life insurance, 401K, and flexible time off.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical researchclinical operationsclinical trial managementphase 1–3 clinical trialsvendor oversightglobal site managementbudget managementtimeline managementrisk managementstudy execution planning

Soft Skills

leadershipcommunicationnegotiationdecision-makingstakeholder managementorganizational skillsproblem-solvingteam managementcross-functional collaborationinterpersonal skills