Associate Director/Director, Clinical Trial Management
Acumen Pharmaceuticals, Inc.
full-time
Posted on:
Location Type: Hybrid
Location: Newton • Massachusetts • United States
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Job Level
Tech Stack
About the role
- 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
- 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
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
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