Senior Director, Clinical Operations — Biologics (Oncology)

BigHat Biosciences; San Mateo (CA); On-site; USD 275,000 - 295,000; Full time

Benefits offered by this job

Health insurance options

Dental & vision coverage

Well-being benefits

401(k) match

Company shutdown days

Paid parental leave

Job summary

BigHat Biosciences in San Mateo, CA seeks an experienced Clinical Operations Lead to drive early‑stage biologics trials in oncology and inflammatory diseases. As Director and Lead, you will shape strategy, oversee trial design and execution, and build a high‑performing operations function.

You will partner with R&D, Regulatory, CMC, and Translational Biomarkers, manage CROs and sites, ensure data integrity and GCP compliance, and guide regulatory interactions.

Qualifications

• Advanced degree in life sciences or related field (PhD/MD/PharmD preferred).
• 10+ years in clinical operations, with oncology/inflammatory diseases experience.
• Experience leading early-phase clinical trials in biotech/pharma.
• Proven ability to build and lead startup teams.
• In-depth knowledge of ICH-GCP, FDA/EMA regulations, and global trial processes.
• Proven vendor management, CRO oversight, budget management, and trial risk management.
• Experience with biomarker sample management and translational support.
• Excellent communication, leadership, and problem-solving skills.
• Experience in oncology, inflammatory diseases, and/or targeted therapies.

Responsibilities

• Develop and execute clinical operational strategies to advance biologics for oncology and inflammatory diseases from early-phase trials to regulatory approval.
• Collaborate with cross-functional teams to align clinical strategies with company goals.
• Provide insights into trial design, site selection, and patient recruitment.
• Lead planning, initiation, and management of Phase I–III trials with global regulatory standards.
• Oversee vendor selection and CRO oversight; ensure protocol adherence and data integrity.
• Monitor trial progress, manage risks, and resolve operational challenges.
• Oversee site-side sample management and chain-of-custody requirements.
• Partner with Translational Biomarker team to support biomarker sample collection and logistics.
• Manage clinical data management, documentation, and regulatory submissions.
• Develop budgets and optimize resources to meet milestones.

Skills

Clinical operations

Team leadership

Oncology/inflammatory diseases

Vendor management

Budget management

ICH-GCP/FDA/EMA knowledge

Trial risk management

Biomarker program support

Site management

Cross-functional collaboration

Education

PhD/MD/PharmD preferred

Job description

BigHat Biosciences in San Mateo, CA seeks an experienced Clinical Operations Lead to drive early‑stage biologics trials in oncology and inflammatory diseases. As Director and Lead, you will shape strategy, oversee trial design and execution, and build a high‑performing operations function.

You will partner with R&D, Regulatory, CMC, and Translational Biomarkers, manage CROs and sites, ensure data integrity and GCP compliance, and guide regulatory interactions.