Architect, Early-Phase Clinical Operations

Soufflé Therapeutics; Watertown (MA); On-site; USD 170,000 - 230,000; Full time

Job summary

Soufflé Therapeutics, a Watertown, MA-based biotech company, seeks an Associate Director of Clinical Operations to build a study from the ground up. This onsite leadership role offers ownership and cross-functional collaboration across Preclinical, Regulatory, and CMC teams.

As the second member of the Clinical Ops team, you will shape processes, drive start-up, enrollment, monitoring, and data collection, and partner with senior leaders to deliver first-in-human studies.

Qualifications

• 8+ years in clinical operations; senior manager level experience.
• Broad knowledge of CFR, ICH GCP, HIPAA, and GDPR.
• Strong problem-solving, leadership, and communication skills.
• Able to work in a fast paced cross-functional team.
• Demonstrated experience leading or starting the studies.
• Experience leading global clinical trials (non-US EU/UK and Australia).

Responsibilities

• Own end-to-end execution of one or more early-phase clinical studies from start-up to close-out.
• Build and manage day-to-day relationships with CROs, sites, central labs, and vendors to keep deliverables high-quality and on schedule.
• Lead site start-up, patient enrollment, monitoring, and protocol compliance with a hands-on approach.
• Author and/or review key clinical documents, including informed consent forms and manuals.
• Ensure timely collection of clinical data, samples, and lab results across all active study sites.

Skills

Clinical operations

Regulatory knowledge

Leadership

Communication

Cross-functional teamwork

Study start-up

Global trials experience

Education

Bachelor's degree

Job description

Soufflé Therapeutics, a Watertown, MA-based biotech company, seeks an Associate Director of Clinical Operations to build a study from the ground up. This onsite leadership role offers ownership and cross-functional collaboration across Preclinical, Regulatory, and CMC teams.

As the second member of the Clinical Ops team, you will shape processes, drive start-up, enrollment, monitoring, and data collection, and partner with senior leaders to deliver first-in-human studies.