Acumen Pharmaceuticals, Inc. · 1 day ago
Associate Director/Director, Clinical Trial Management
Boston, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
10+ years expAcumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic for the treatment of Alzheimer’s disease. The Associate Director/Director, Clinical Trial Management is responsible for overseeing the operational planning, execution, and delivery of clinical studies, ensuring quality, timelines, budget, and inspection readiness.
BiotechnologyHealth DiagnosticsTherapeutics
Responsibilities
In collaboration with Clinical Operations lead, lead operational management of assigned clinical studies from protocol synopsis through study close‑out, including start‑up, enrollment, conduct, database lock, and Clinical Study Report (CSR)
Develop and own the operational strategy and study execution plans (e.g., monitoring plan, Trial Master File (TMF) plan, risk management plan) or oversee such activities if outsourced to a Clinical Research Organization (CRO), ensuring alignment with clinical development objectives
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, including selection, contract and budget input, performance management, issue escalation, and ensuring compliance with ICH‑GCP and sponsor obligations
Oversee site feasibility, selection, activation, and performance, ensuring recruitment and retention targets are achieved and supporting co‑monitoring or site visits as needed
Ensure trial activities are conducted per protocol, Good Clinical Practice (GCP), local regulations, company SOPs, and inspection‑readiness standards, supporting audits/inspections and CAPA implementation
Manage study timelines, critical path, and key performance indicators; proactively identify risks and implement mitigation and contingency plans
Contribute to and/or oversee development and review of essential trial documents (protocol, ICFs, study manuals, training materials, study tools)
Provide support or directly manage study budgets and forecasts in collaboration with finance, including vendor invoices, change orders, and cost tracking versus plan
Provide regular study status updates to Clinical Operations leadership, program leadership and/or senior management, including dashboards, metrics, and issue escalation summaries
Manage overall performance of the TMF to ensure compliance and inspection readiness, including if TMF management is outsourced to the CRO
Work with Clinical Operations and other cross functional team members to establish TMF health improvement and inspection readiness strategies
Support preparation of documentation required for regulatory agency inspections and internal audits
Support or lead continuous process improvement and contribute to refinement of clinical operations SOPs (including authoring of SOPs), tools, and best practices
Directly oversee Clinical Trial Managers and/or Clinical Research Associates, providing coaching and performance feedback and supporting development
Qualification
Required
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
This is a remote position. Required to attend company meetings, business, or study-related meetings in person
Must be willing to travel 25%
Must be flexible and able to work in a dynamic, fast-paced environment
Preferred
Prior global study leadership and clinical trial experience in CNS strongly preferred
Benefits
Competitive base salary
Eligibility for an annual incentive bonus
Eligibility to participate in company stock option plan
Competitive benefits package including health, dental, vision, life insurance, 401K, and flexible time off
Company
Acumen Pharmaceuticals, Inc.
Acumen is forging a new path towards safe and effective treatments for Alzheimer’s disease and other neurodegenerative diseases through our focus on the biology of toxic soluble amyloid-beta oligomers.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$295.1MKey Investors
K2 HealthVenturesNational Institute on Aging
2023-11-13Post Ipo Debt· $50M
2023-07-17Post Ipo Equity· $130M
2021-06-30IPO
Leadership Team
Daniel O'Connell
Chief Executive Officer
W. Matthew Zuga
Chief Financial Officer & Chief Business Officer
Recent News
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