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Head of Clinical Operations & Development Operations

Job in South San Francisco, San Mateo County, California, 94083, USA
Listing for: Dualitas Therapeutics
Full Time position
Listed on 2026-10-05
Job specializations:
  • Research/Development
    Regulatory Compliance Specialist, Clinical Research
Salary/Wage Range or Industry Benchmark: 275000 - 330000 USD Yearly USD 275000.00 330000.00 YEAR
Job Description & How to Apply Below

Company Overview

Dualitas Therapeutics is a South San Francisco-based biotechnology company developing next-generation bispecific antibody therapies for immune and inflammatory diseases. Founded in 2023 by a team of experienced biotherapeutic engineers and drug developers, Dualitas emerged from stealth in September 2025 with a $65 million Series A financing co-led by Versant Ventures and Qiming Venture Partners USA, joined by founding investor SV Health Investors and strategic investors Chugai Venture Fund, Eli Lilly and Company, and Alexandria Venture Investments.

The company’s proprietary Dual Screen™ discovery engine functionally screens entire cell surfaceomes — arraying more than 100,000 unique bispecific combinations in high-throughput assays — to identify synergistic, rather than merely additive, antibody pairings. The pipeline is led by DTX-102, an anti-CD28 bispecific for rheumatoid arthritis currently in IND-enabling studies, alongside DTX-101 (anti-IL-2Rβ, for dermatologic and gastrointestinal autoimmune disease) and DTX-103 (anti-FcεR1, for allergic disease), plus an early-stage discovery pipeline of additional bispecific combinations.

As we advance DTX-102 through IND-enabling activities and toward our first clinical trial, we are building the operational backbone needed to execute high-quality, efficient clinical development.

Our work at Dualitas Therapeutics is guided by three Operating Principles:

  • Get Things Done Creatively as One Team — proposing solutions, aligning stakeholders, and moving work forward.
  • Advance Differentiated Medicines with Scientific Rigor — applying disciplined clinical development judgment and data-driven decision-making.
  • Operate with Urgency, Discipline and Grit — driving timelines, mitigating risks, and maintaining executional focus.
Position Summary

The Head of Clinical Operations & Development Operations will be a foundational operational leader responsible for building the clinical and development execution engine as Dualitas prepares to enter the clinic. This role brings together Clinical Operations — the planning, execution, and oversight of clinical trials — and Development Operations — the cross-functional program management, systems, and processes that connect Clinical, CMC, Regulatory, Nonclinical, and Quality into an integrated development effort.

Reporting to the CMO and based on-site in South San Francisco, this leader will establish the scalable processes, vendor partnerships, governance rhythms, and operational infrastructure required to support First-in-Human trial start-up for DTX-102 and the pipeline that follows. The successful candidate will combine strategic judgment with hands-on execution: someone who can translate scientific and clinical strategy into clear operating plans, align cross-functional stakeholders, anticipate and mitigate risk, and drive high-quality execution with urgency, discipline, and resilience in a fast-moving, early-stage environment.

Key Responsibilities
Clinical Operations — Trial Execution
  • Lead end-to-end operational execution of clinical trials, beginning with First-in-Human start-up for DTX-102 and extending to site selection and activation, patient enrollment, monitoring, and close-out for follow-on programs.
  • Select, contract, and manage CROs and functional service providers (CRAs, central labs, imaging vendors, IRT/RTSM, biostatistics/data management vendors), ensuring performance against timeline, budget, and quality metrics.
  • Develop and manage clinical trial budgets, timelines, and risk mitigation plans; proactively identify and resolve enrollment, site, and vendor issues.
  • Oversee clinical trial systems (CTMS, eTMF, EDC, IRT) and ensure inspection-ready trial master files and GCP-compliant…
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