Associate Director, Clinical Operations

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

📋 Description

• Design and implement early-phase clinical trials, primarily concentrating on oncology initiatives.

• Collaborate with both internal and external stakeholders to strategize, execute, and resolve issues throughout the course of clinical trials.

• Lead interactions with sites and CROs, encompassing study initiation, drug and budget forecasting, as well as the acquisition of high-quality clinical and translational data.

• Act as the clinical operations program lead for at least one program and its associated studies.

• Direct a team of clinical operations personnel.

• Formulate the clinical operations strategy for assigned development programs.

• Work collaboratively across functions to create protocols, annual safety reports, investigator brochures, clinical study reports, presentations, regulatory submissions, and publications.

• Assess and select CROs, sites, and other external partners; create vendor scopes of work, contracts, quality plans, monitoring plans, and budgets.

• Develop and oversee SOPs while ensuring compliance with GCP standards.

• Review vendor performance, address challenges, and propose solutions.

• Create and manage study timelines in collaboration with internal partners.

• Attend and present at study site initiation meetings and study calls as necessary.

• Plan and forecast patient recruitment efforts.

• Oversee or mentor members of the Clinical Operations team.

⛳️ Requirements

• A minimum of 8 years of experience in clinical operations across at least 2 therapeutic areas, including oncology.

• Experience in managing CROs and vendors in both US and international clinical trials.

• Background in site initiation visits, site management, and data analysis for publication and regulatory needs.

• Comprehensive understanding of the drug development process from IND to NDA.

• Strong ability to communicate effectively and efficiently.

• Willingness to provide training to other team members both within and outside of Clinical Operations.

• Experience in large pharmaceutical companies and biotech, as well as with biomarker-selected studies is preferred but not mandatory.

• Familiarity with at least one report is preferred; however, strong practical experience and a growth-oriented mindset will also be taken into account.

🏝️ Benefits

• Annual bonus.

• Equity compensation.

• Competitive benefits package.