Clinical Operations Associate Director

Summary

Join Generate:Biomedicines as an Associate Director of Clinical Operations for a 6-month contract role, working remotely. You will plan and execute early-stage clinical trials across oncology, immunology, and infectious diseases. Responsibilities include developing clinical operations strategies, collaborating cross-functionally, evaluating external collaborators, developing SOPs, ensuring GCP compliance, managing timelines, and attending study meetings. The ideal candidate will have at least 8 years of experience in clinical operations across at least two therapeutic areas, experience managing CROs, and experience leading clinical programs. This is a 40-hour per week contract position offering $85-90 per hour.

Requirements

• Associate Director level; Minimum 8 years of experience in clinical operations across at least 2 therapeutics areas
• Experience managing CROs and vendors both in the US and in international clinical trials
• Experience serving as the clinical operations lead for one or more clinical programs
• Experience in site initiation visits, site management, data cuts for publication and regulatory requirements
• Understanding of the drug development process from IND to NDA
• Dedication to collaborative work in a fast-paced environment; open-mindedness to shifting strategy in a data-guided manner
• Ability to communicate effectively and efficiently and willingness to train other team-members within and outside of Clinical Operations

Responsibilities

• Develop clinical operations strategy for each agent in development, either directly or by leading study staff depending on the stage of the agent
• Cross-functional collaboration to develop needed outputs such as protocols, annual safety reports and investigator brochure, clinical study reports, presentations, regulatory submissions and publications
• Evaluate external collaborators including Contract Research Organizations (CROs) and sites and select the best candidates for each needed function. Develop vendor scope of work, contract, quality, monitoring and budget
• Develop and manage standard operating procedures (SOPs) for the organization and its external collaborators. Ensure GCP compliance
• Continuously evaluate performance of external collaborators and vendors, troubleshoot and recommend a path forward when challenges are encountered
• Develop and manage study timelines, working with internal partners (including but not limited to clinical development, clinical pharmacology and other quantitative functions, data management, biomarkers and translational, CMC, regulatory affairs and project management)
• Attend and, where appropriate, present at study site initiation meetings and study calls
• Patient recruitment planning and forecasting

Preferred Qualifications

• Experience in large Pharma and biotech and with biomarker-selected studies
• Experience with at least one report

Benefits

• $85-90 per hour for this Contract
• Open to Remote