Senior/Clinical Program Manager, Clinical Operations

JOB SUMMARY 

The Senior/Clinical Program Manager of Clinical Operations is responsible for leading the operational planning and execution of one or more clinical trials from study start-up through completion. This role ensures that clinical studies are conducted in accordance with applicable regulations, ICH-GCP, FDA/EMA regulations, and company standard operating procedures (SOPs), and within agreed timelines and budgets. This individual will collaborate closely with internal teams and external vendors/CROs to ensure high-quality trial execution, while contributing to strategic planning and continuous process improvement across the clinical operations function. This role will report to the Director of Clinical Operations and is based in San Diego, CA.

KEY RESPONSIBILITIES 

• Lead the operational planning and execution of Phase I-III oncology clinical trials, ensuring timely study start-up, site activation, patient enrollment, and database lock.  

• Oversee trial conduct in accordance with ICH-GCP, FDA/EMA regulations, and company SOPs.  

• Collaborate closely with internal teams including Clinical Development, Regulatory Affairs, Translational Science, and Biometrics to ensure alignment across program goals.  

• Provide clear and consistent updates to leadership, program teams, and external stakeholders on study status, risks, and key operational metrics. 

• Act as a key liaison to external CROs, vendors, and investigational sites, driving accountability and performance. 

• Identify and implement process improvements to increase efficiency, reduce startup timelines, and mitigate operational risks.  

• Select, negotiate with, and manage CROs and other external partners to support study operations. Track clinical budgets, monitor KPIs, and ensure financial accountability for outsourced services 

• Mentor and supervise junior clinical operations staff.  

QUALIFICATIONS 

• Bachelor’s degree in Life Sciences or related field  

• 8+ years of experience in clinical operations, with at least 4 years in oncology 

• Proven track record of career development, with progression in level of clinical trial responsibilities 

• Experience in managing global clinical trials and working with CROs and vendors 

• Strong knowledge of GCP, ICH guidelines, and global regulatory requirements 

• Excellent organizational, leadership, and communication skills 

• Ability to work independently in a fast-paced, evolving environment 

ABOUT IAMBIC THERAPEUTICS 

Founded in 2019 and headquartered in San Diego, California, Iambic Therapeutics is disrupting the therapeutics landscape with its unique AI-driven drug-discovery platform. Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters with strong track records of success in delivering clinically validated therapeutics. The Iambic platform has been demonstrated to deliver high-quality, differentiated therapeutics to clinical stage with unprecedented speed and across multiple target classes and mechanisms of action. The Iambic team is advancing an internal pipeline of clinical assets to address urgent unmet patient needs. Learn more about the Iambic team, platform, and pipeline at iambic.ai. 

 MISSION & CORE VALUES 

Our mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies. 

 PAY AND BENEFITS 

We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.