Head of Clinical & 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

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