Associate Director, Clinical Operations
About The Position
The Associate Director, Clinical Operations leads and manages the assigned clinical operations team and plays a key role in setting and executing departmental strategy. The role oversees clinical trial agreements, budgets, expenditures, and payments, and ensures clinical research programs are executed on time from conception through the final clinical study report. This includes oversight of external contract organizations and their responsibilities for site activities, monitoring, data management, biostatistics, IRB interactions, central laboratories, budget negotiations, medical writing, pharmacovigilance, and other critical functions. The position maintains relationships with clinical study sites and oversight of study conduct, supports preparation and management of protocols and amendments, and assists with key clinical documents. It contributes to Investigator Sponsored Trials, internal SOPs, and work-practice documents designed to support regulatory compliance. The Associate Director collaborates with medical and cross-functional teams, directly supervises and develops Clinical Operations staff, and represents the company at external meetings and scientific congresses. Travel may be required up to 20% of the time.
Requirements
- Bachelor’s degree in a health- or science-related area.
- At least 8 years of pharmaceutical or biotech-related/clinical research experience.
- Oncology or immuno-oncology experience.
- Demonstrated experience leading core and technical aspects of Phase 1–4 trials and supporting investigator-initiated trials.
- Demonstrated success managing clinical studies within timelines and budget.
- Managerial skills and strong verbal and written communication and interpersonal skills for working with clinical monitors, investigators, specialized groups, and internal teams.
- Ability to build strong relationships across functional teams to engage high performance.
- Ability to assimilate information quickly, identify critical factors and risks, and implement changes when needed.
- Negotiation, influencing, and problem-solving skills to meet study timelines.
- Ability to set high standards for accountability and quality in deliverables.
- Proactive, self-directed, adaptable approach in a rapidly changing environment.
- Ability to embrace others’ ideas, promote innovation, and manage goals through to execution.
- Flexible approach to working in a fast-paced biotechnology company and willingness to perform necessary tasks to help complete projects or programs.
- In-depth knowledge of PC operating systems and Microsoft Office, including Word, Excel, PowerPoint, Project, Publisher, Outlook, and Windows NT.
- Exposure to CTM systems, EDC systems (eClinical, Medidata RAVE, InForm), and safety/pharmacovigilance databases (ARGUS).
Responsibilities
- Oversee clinical trial agreements, budgets, expenditures, and payments for clinical studies.
- Ensure timely execution of clinical research programs and protocols from conception through final clinical study report, including supervision of external contract organizations.
- Establish and maintain working relationships with study-site personnel to support protocol and GCP adherence, quality data, and study timelines.
- Oversee study conduct at centers, including site selection, start-up, monitoring, protocol and GCP compliance, applicable guidance, and study closure.
- Contribute to the preparation and management of clinical study protocols and protocol amendments.
- Assist with preparation of Investigator Brochures, FDA Briefing Documents, and internal or external presentations.
- Contribute to the review of Investigator Sponsored Trials and supporting documentation.
- Contribute to internal SOPs and Clinical work-practice documents and their implementation in accordance with FDA and EMA regulations.
- Interface with the Chief Medical Officer/Medical Monitor and cross-functional teams, including Data Management, Drug Safety, Logistics/Manufacturing, Project Management, Regulatory Affairs, and Biostatistics.
- Directly supervise Clinical Operations team members, including performance management and development planning.
- Represent the company at external meetings and scientific congresses.
- Adhere to company core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
- Travel up to 20% of the time.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
