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About the Role
This foundational operational leadership role is responsible for building the clinical and development execution engine as Dualitas prepares to enter the clinic. The role integrates Clinical Operations and Development Operations, establishing scalable processes, vendor partnerships, governance rhythms, and operational infrastructure to support First-in-Human trial start-up and subsequent pipeline development. The ideal candidate will translate scientific and clinical strategy into operating plans, align stakeholders, mitigate risk, and drive high-quality execution in an early-stage environment.
Responsibilities
- Lead end-to-end operational execution of clinical trials, including First-in-Human start-up, site selection and activation, patient enrollment, monitoring, and close-out.
- Select, contract, and manage CROs and functional service providers, ensuring performance against key metrics.
- Develop and manage clinical trial budgets, timelines, and risk mitigation plans.
- Oversee clinical trial systems (CTMS, eTMF, EDC, IRT) and ensure inspection-ready documentation.
- Partner with the Medical Monitor/CMO on protocol development and site-facing guidance.
- Build and lead cross-functional program management for development programs, integrating timelines across Clinical, CMC, Regulatory, Nonclinical, and Quality.
- Establish core development infrastructure including SOPs, quality systems, and governance frameworks.
- Own integrated development timelines and budgets, driving program-level risk identification and scenario planning.
- Lead or support due diligence for business development and licensing activities, and for investor/board reporting.
- Negotiate and manage contracts with CROs and other third-party vendors.
- Establish vendor oversight practices appropriate for a lean organization.
- Build, mentor, develop, and manage the Clinical Operations and Development/Program Management functions.
- Serve as a key operational partner to the CMO and executive team, translating strategy into executable plans.
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.
- 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.
- 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.
- Sound judgment on when to escalate risk.
- Collaborative, adaptable, and energized by the pace and ambiguity of an early-stage company.
Skills
- Clinical Operations
- Development Operations
- Program Management
- Vendor Management
- Contract Negotiation
- Budget Management
- Risk Mitigation
- GCP/ICH Guidelines
- Cross-functional Collaboration
- Process Development
- System Implementation
Location
- South San Francisco
Work Type
- On-site
- Full-time
Experience Level
- 15+ years of experience
- Head of Function Leadership
Education Level
- Bachelor's degree
- Advanced degree preferred
Salary/Compensations
- $275,000 - $330,000 annually
Benefits
- Competitive base salary
- Equity
- Comprehensive benefits package
- Medical insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
- Annual performance bonuses
About the Company
- 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 experienced biotherapeutic engineers and drug developers.
- Emerges from stealth in September 2025 with a $65 million Series A financing.
- Proprietary DualScreen™ discovery engine screens over 100,000 unique bispecific combinations.
- Pipeline led by DTX-102 for rheumatoid arthritis, DTX-101 for autoimmune disease, and DTX-103 for allergic disease.
- Operating Principles: Get Things Done Creatively as One Team, Advance Differentiated Medicines with Scientific Rigor, Operate with Urgency, Discipline and Grit.
Equal Opportunity
- Dualitas Therapeutics is an equal opportunity employer.
- We celebrate diversity and are committed to creating an inclusive environment for all employees.