Clinical & Development Operations Leader

Dualitas Therapeutics

South San Francisco (CA)

On-site

USD 275,000 - 330,000

Full time

38 hours ago

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Benefits offered by this job

Equity

Competitive benefits

On-site in South San Francisco

Job summary

Dualitas Therapeutics is seeking a Head of Clinical Operations & Development Operations to build the execution engine for its first-in-human program DTX-102 and future pipelines. The role integrates Clinical Operations and Development Operations to align strategy with hands-on execution.

The person will report to the CMO, be based on-site in South San Francisco, and establish scalable processes, vendor governance, and infrastructure to support early-stage development with urgency, discipline,

Qualifications

Bachelor's degree required; advanced degree preferred (MS, MBA, PharmD).
15+ years in clinical operations and/or development operations in biotech or pharma.
Minimum 3 years in head-of-function leadership.
Experience from First-in-Human through Phase 1b/2 trials.
Proven track record selecting, contracting, and managing CROs and vendors.

Responsibilities

Lead end-to-end operational execution of clinical trials from start-up to close-out.
Build and lead cross-functional program management across Clinical, CMC, Regulatory, Nonclinical and Quality.
Establish SOPs, quality systems, document control, and governance frameworks.
Own integrated timelines and budgets; drive risk identification and resource allocation.
Negotiate and manage CROs and third-party vendors in partnership with Legal and Finance.