Associate Director, Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and oversee the designated Clinical Operations team

• Assist in developing and implementing departmental strategies

• Manage clinical trial agreements, financial budgets, expenditures, and payment processes

• Ensure the prompt execution of clinical research programs and protocols from inception to the final clinical study report

• Supervise external contract organizations involved in site interaction, monitoring, data management, biostatistics, IRB interactions, central laboratory functions, budget negotiations, medical writing, pharmacovigilance, and various other activities

• Cultivate relationships with clinical study site personnel to guarantee protocol compliance, adherence to Good Clinical Practice, high-quality data, and adherence to study timelines

• Oversee the conduct of studies at centers, including site selection, initiation, monitoring, compliance with protocols/GCP, guidance adherence, and study closure

• Contribute to the development of clinical study protocols and any necessary amendments

• Assist with the preparation of Investigator Brochures, FDA Briefing Documents, and related presentations

• Review Investigator Sponsored Trials along with their supporting documentation

• Contribute to the creation of internal SOPs and Clinical work practice documents in compliance with FDA and EMA regulations

• Collaborate with the Chief Medical Officer/Medical Monitor and cross-functional teams

• Manage Clinical Operations team members, focusing on performance management and development planning

• Represent the company at external meetings and scientific congresses

• Uphold company values, policies, procedures, and ethical standards

• Perform additional duties as assigned

⛳️ Requirements

• Bachelor’s Degree in a health or science-related field

• Over 8 years of experience in pharmaceuticals, biotech, or clinical research

• Experience in oncology/immuno-oncology is essential

• Proven track record leading Phase 1–4 trials and supporting investigator-initiated trials

• Demonstrated success in managing clinical studies within set timelines and budgets

• Strong managerial, interpersonal, verbal, and written communication skills

• Ability to forge relationships across various functional teams

• Quick to assimilate information and implement necessary changes

• Proficient in negotiating, influencing, and solving problems

• Ability to maintain accountability and ensure quality in deliverables

• Proactive, self-motivated, and adaptable approach

• Flexibility to carry out tasks in a fast-paced biotechnology setting

• Comprehensive knowledge of PC operating systems and Microsoft Office Suite, including Word, Excel, PowerPoint, Project, Publisher, Outlook, and Windows NT

• Familiarity with CTM systems and EDC systems like eClinical, Medidata RAVE, and InForm

• Exposure to Safety/Pharmacovigilance databases such as ARGUS

• Willingness to travel up to 20% of the time

• Capability to meet the physical, visual, communication, and mental demands of the position

🏝️ Benefits

• Remote office environment

• Equal-opportunity and inclusive workplace

• Reasonable accommodations available upon request