Sr. Project Manager - CMC & Clinical Development Operations

Job Summary

Iambic Therapeutics is seeking an experienced and detail-oriented Project Manager to join our team and lead integrated project management across clinical development functions, with primary responsibility for the CMC and Clinical Operations departments. This role will serve as the operational anchor for CMC execution, driving cross-functional planning, vendor management, and regulatory alignment. Additionally, the Project Manager will work closely with the Clinical Operations team to manage and track clinical study timelines and deliverables from study start-up through execution.

This position requires a strong background in small molecule pharmaceutical development, excellent project management skills, and the ability to coordinate complex activities across multiple work streams and external partners. Experience in oncology drug development and familiarity with both CMC and Clinical Operations is highly desirable.

Key Responsibilities

• Lead planning, execution, and tracking of project timelines and deliverables across CMC and Clinical Operations to ensure alignment with program milestones and corporate goals.
• Drive day-to-day project management of CMC activities, including drug substance, drug product, analytical development, and regulatory documentation, in close collaboration with internal technical teams and external CDMOs.
• Manage relationships with third-party vendors (e.g., CDMOs, CROs), including oversight of scope, deliverables, timelines, and performance to ensure quality and accountability.
• Develop, integrate, and maintain detailed project plans across development workstreams, including scenario planning, resource forecasting, risk assessments, and budget tracking.
• Serve as the key CMC point of contact for internal cross-functional teams, ensuring timely coordination, clear communication, and proactive risk mitigations.
• Partner with the Clinical Operations team to develop, update, and track clinical study timelines and critical path activities from study start-up through execution.
• Facilitate internal and external team meetings by creating agendas, capturing meeting minutes and decisions, tracking action items, and ensuring timely follow-through.
• Maintain accurate project documentation, including status reports, risk registers, timelines, and meeting records across both CMC and clinical activities.
• Drive coordination and timeline tracking for CMC components of regulatory submissions (e.g., INDs, IMPDs, NDAs, MAAs) in collaboration with the Regulatory CMC team, ensuring timely input from internal teams and CDMOs.
• Monitor progress against project plans and proactively identify risks, delays, or resource gaps; lead or support development and implementation of mitigation strategies.
  
  

Qualifications

• Bachelor’s degree in science or engineering field with 7+ years of project management experience in the pharmaceutical or biotechnology industry, or a Master’s degree with 5+ years of relevant experience.
• Strong background in small molecule pharmaceutical development; oncology experience preferred.
• Demonstrated experience in project management within CMC and/or clinical development functions.
• Proven ability to manage timelines, cross-functional coordination, and third-party vendor relationships.
• Familiarity with regulatory submission processes, including coordination of CMC components.
• Excellent organizational, communication, and interpersonal skills with the ability to work across disciplines and levels.
• Proficiency in project management tools (e.g., MS Project, Smartsheet, SharePoint, or similar).
• Ability to travel up to 10% domestically and internationally.
• PMP certification or formal project management training is a plus
  
  

About Iambic Therapeutics

Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships 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.