Associate Director 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 is a biotech company focusing on the cell-type specific delivery of genetic medicines. It's team of driven scientists is making a mark in delivery of oligonucleotides to extrahepatic tissues. We thrive in a purpose-building lab and office space in Watertown. Come and join us in our quest!

Soufflé Therapeutics is launching a new clinical program, and we're looking for an Associate Director of Clinical Operations to help build it from the ground up. This is a rare chance to shape a study from first principles: you won't inherit someone else's playbook, you'll write it. As the second member of a growing Clinical Ops team, you'll partner directly with our Senior Director and cross-functional leaders across Preclinical, Regulatory, and CMC to take an early-phase study from start-up through close-out. If you thrive on ownership, love the scrappy energy of a "department of three," and want your fingerprints on every stage of a trial, this role is built for you.

Key Responsibilities

• Own end-to-end execution of one or more early-phase clinical studies, serving as the operational lead from study start-up all the way through close-out and the final Clinical Study Report
• Build and manage day-to-day relationships with CROs, clinical 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, accountability-driven approach that keeps studies moving
• Author and/or review key clinical documents, including informed consent forms, pharmacy manuals, and other trial-related materials
• Ensure timely collection of clinical data, samples, and lab results across all active study sites

What Success Looks Like

• In 3 months: You've gotten fluent in the protocol and study design, built relationships with key stakeholders, and are actively helping author and/or review core study documents and driving study start-up activities end to end, from site feasibility and selection through initiation and vendor onboarding
• In 6 months: You're leading independently every aspect of the study, including sites, CROs, and vendors like labs and imaging partners, with full command of the program
• In 12 months: You're managing all aspect of the study, including multiple sites, CROs, and vendor and supporting life cycle management studies, supporting next studies/other programs as needed

Qualifications — Required

• 8+ years of experience in clinical operations, including 2-3 years in a Senior Manager or comparable role (Associate Director level at a similar-sized company)
• Broad working knowledge of global regulations and guidelines, including CFR, ICH GCP, HIPAA, and GDPR
• Excellent problem-solving, leadership, and communication skills.
• Ability 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).

Qualifications — Preferred

• Experience leading US clinical trials
• Early Clinical Trial Experience

Education

• Bachelor's degree (BA/BS) required

At Soufflé Therapeutics, we are intentional about building an equitable culture. How we treat our people is reflective of this focus. Our pay structure is base salary + bonus + equity.

This is an onsite position in Watertown, MA (US) with flexibility as needed for collaboration and external engagements. We are an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.