Position SummaryThe 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 ResponsibilitiesClinical 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 documentation.
- Partner with the Medical Monitor/CMO on protocol development, informed consent documents, and site-facing medical/operational guidance.
Development Operations - Program & Process Infrastructure- 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.
Vendor & Contract Management- 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.
Team & Organizational Build-Out- 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.
QualificationsEducation & Experience- 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.
Skills & Attributes- 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.
What We Offer- A foundational leadership role shaping how Dualitas runs clinical trials and executes development programs, starting with DTX-102's path to the clinic.
- Direct, high-visibility partnership with the CMO and executive leadership team.
- Competitive base salary, equity, and benefits package.
CompensationThe expected base pay range for this position, in California, is $275,000 - $330,000 annually and will depend on several factors, including but not limited to, the candidate's geographic location, experience, skills and competencies. The posted pay range reflects multiple levels within the Management Career track. The final level and compensation will be determined based on the candidate's qualifications and relevant experience.
This role is also eligible for annual performance bonuses, equity grants, and a comprehensive benefits package that includes medical, dental, vision, retirement plan, paid time off, and other employee programs.
