Associate Director, Clinical Operations Lead -Asthma

Associate Director, Clinical Operations Lead - Asthma

Generate : Biomedicines is a new kind of therapeutics company existing at the intersection of machine learning, biological engineering, and medicine pioneering Generative Biology to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate : Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role

We are expanding our late-stage development organization and adding a new Associate Director, Clinical Operations Lead to support global execution for our asthma program. In this individual contributor role, you will serve as the operational leader for complex, late-stage clinical trialsowning strategy, planning, execution, quality, and delivery. You'll collaborate cross-functionally and with CRO partners to ensure studies are executed with rigor, efficiency, and patient-first focus.

Heres How You Will Contribute

Study Leadership & Strategy

• Serve as the operational lead for global Phase 3 asthma studies, ensuring successful planning, execution, and delivery of study objectives.
• Develop overall study strategy, timelines, and operational plans aligned with program goals and regulatory expectations.
• Lead scenario planning, risk assessment, and proactive mitigation efforts to maintain quality and timelines.
• Review and approve key trial documents, including protocols, amendments, plans, and manuals.

Cross-Functional Collaboration

Operational Execution & Risk Management

Data Quality & Delivery

Stakeholder & Vendor Management

Leadership & Development

The Ideal Candidate Will Have

Education

Nice to Have

Who Will Love This Job

Generate : Biomedicines is pioneering Generative Biology to design and develop novel therapeutics with unprecedented precision. You'll join a collaborative, curious, patient-first team where scientific creativity and operational excellence come together to advance programs with the potential for large-scale impact. As we expand our late-stage capabilities, you will have direct influence on how we build, deliver, and continuously improve.

Generate : Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.