Associate Director, Clinical Business Operations

Hamlyn Williams; Boston (MA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

A leading biopharmaceutical company is seeking an Associate Director for Clinical Business Operations in the Greater Boston area. This role involves improving clinical operations through process development, risk management, and supporting the growth of the department. The ideal candidate will have a strong scientific background and extensive experience in clinical trial processes, particularly in oncology and rare diseases.

Qualifications

• Experience in multiple phases of clinical trial development, especially in oncology and rare diseases.
• Deep expertise in end-to-end clinical trial processes.
• Knowledge of GCP and US FDA regulations.

Responsibilities

• Drafting and developing processes to improve clinical operations.
• Leading risk management activities across studies.
• Managing onboarding and offboarding tools.

Skills

Clinical trial conduct

Process design

Risk management

Operational excellence

Education

Scientific degree

PMP certification

Job description

Associate Director, Clinical Business Operations - Functional Excellence (Clinical Operations)

Contract: 40hrs/wk (temp to perm)

Hybrid: Greater Boston

Biopharmaceuticals - oncology and rare diseases

Reporting to the Senior Director of Clinical Operations

Core Duties:

• Drafting, developing, and creating processes and guidance documents to improve consistency and alignment within Clinical Operations and Clinical Trial Teams
• Development and implementation of tools, guidelines, and training for study-related processes, including presenting at team meetings and other cross-functional forums
• Support the evolving business needs and growth of the department, including SME sponsorship and training needs.
• Development and execution of continuous improvement initiatives (risk evaluation and mitigation), KPI and dashboard development, Smartsheet update, best practices in business processes, operational excellence principles
• Manages the Clinical Operations Tool Kit, reviewing and approving ongoing submissions
• Serve as Clinical Operations SME and process owner for Clinical Operations-related activities
• May serve as a resource for COSLs if gaps or inconsistencies in study management arise, leading the effort to gain alignment and clarity through informed decision making with key stakeholders.
• Support the onboarding of new team members and manage onboarding and offboarding tools
• Lead risk management activities across studies

Qualifications

• Scientific degree preferred
• PMP certification preferred
• Clinical trial conduct in multiple phases of development across several therapeutic areas, including oncology and or rare diseases.
• Deep experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, project management) required. (not just managing timelines/budgets but understanding trial processes, GCP, regulatory compliance).
• Experience in clinical trial process design and improvement activities, and training and implementation required.
• Detailed knowledge of GCP and US FDA regulations