Head of Clinical Operations & Development Operations
About The Position
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.
Requirements
- Bachelor's degree required; advanced degree (MS, MBA, PharmD, or related) preferred.
- 15+ years of clinical operations and/or program/development operations experience in biotech or pharma, including a minimum of 3 years in a head-of-function leadership role.
- Direct experience managing First-in-Human through Phase 1b/2 trials from start-up through close-out; immunology, inflammation, or immune-mediated disease trial experience strongly preferred.
- Successful track record selecting, contracting, and managing CROs and other clinical vendors.
- Experience building or scaling clinical operations and/or program management infrastructure at an early-stage or small biotech company preferred.
- Strong working knowledge of GCP/ICH guidelines and clinical trial regulatory requirements.
- Excellent cross-functional program management skills, with the ability to synthesize inputs from Clinical, CMC, Regulatory, and Nonclinical into coherent, integrated plans.
- Comfortable operating with limited infrastructure and building processes and systems from scratch.
- Strong vendor management and negotiation skills.
- Clear communicator, well-organized, and detail-oriented, with sound judgment on when to escalate risk.
- Collaborative, adaptable, and energized by the pace and ambiguity of an early-stage company.
Responsibilities
- 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 documentation.
- Partner with the Medical Monitor/CMO on protocol development, informed consent documents, and site-facing medical/operational guidance.
- Build and lead cross-functional program management for development programs, integrating timelines and dependencies across Clinical, CMC/Manufacturing, Regulatory, Nonclinical, and Quality.
- Establish core development infrastructure appropriate for an early-stage company: SOPs, quality systems, document control, and governance/decision frameworks (e.g., program/portfolio review, go/no-go criteria).
- Own integrated development timelines and budgets; drive program-level risk identification, scenario planning, and resource allocation in partnership with Finance.
- Lead or support due diligence for business development and licensing activities, and for investor/board reporting on program progress.
- Negotiate and manage contracts with CROs and other third-party vendors (CDAs, MSAs, Work Orders, CTAs), in partnership with Legal and Finance.
- Establish vendor oversight practices appropriate for a lean organization, balancing rigor with efficient use of internal resources.
- Successfully build, mentor, develop, and manage the Clinical Operations and Development/Program Management functions as the company scales, including future hires (CRAs/CTMs, Clinical Trial Managers, Program Managers).
- Serve as a key operational partner to the CMO and executive team, translating scientific and clinical strategy into executable plans.
Benefits
- Competitive base salary, equity, and benefits package.
- medical, dental, vision, retirement plan, paid time off, and other employee programs.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
