Head of Clinical Operations & Development Operations

Dualitas Therapeutics, Inc.; San Francisco, Northern (CA, KY); Hybrid; USD 275,000 - 330,000; Full time

Benefits offered by this job

Equity

Benefits package

On-site in South San Francisco

Job summary

Dualitas Therapeutics, Inc. in California seeks a senior leader to build and run the Clinical Operations and Development Operations engine as the company advances its bispecific programs.

You will lead end‑to‑end trial execution, program management, and vendor oversight from site activation through close‑out, partnering with the CMO and executive team to translate scientific strategy into executable plans. The role requires 15+ years in biotech/pharma operations, with hands-on experience in

Qualifications

• 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/pharma, including 3+ years in head-of-function leadership.
• Experience leading First‑in‑Human through Phase 1b/2 trials in immunology/inflammation.
• Proven track record contracting and managing CROs and vendors.
• Experience scaling clinical operations/infrastructure at early-stage companies.

Responsibilities

• Lead end-to-end operational execution of clinical trials from FIH start-up.
• Select, contract, and manage CROs and vendors with timelines, budget, and quality in mind.
• Develop and manage trial budgets, timelines, and risk mitigation.
• Oversee trial systems (CTMS, eTMF, EDC, IRT) and ensure GCP documentation.
• Partner with CMO on protocol development and site-facing guidance.
• Build cross-functional program management for development programs.

Skills

GCP/ICH knowledge

Cross-functional program management

Vendor management

Clear communicator

Strategic planning

Education

Bachelor's degree

Advanced degree preferred (MS, MBA, PharmD)

Tools

CTMS

eTMF

EDC

IRT

Job description

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 DualScreen™ 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 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.

Qualifications

Education & 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 escal…
• 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.

Compensation

The 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.

Dualitas Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.