Senior Director Clinical Operations

HW3; United States; On-site; USD 250,000 - 350,000; Full time

Job summary

Hw3 Llc is seeking a Senior Director of Clinical Operations to lead strategy and execution across one or more biotech programs from early development through pivotal trials in the United States.

The role emphasizes rare diseases and CNS indications, global Phase 3 trial leadership, and oversight of CROs, vendors, consultants, and sites, with a track record of NDA/BLA/MAA contributions and team mentorship.

Qualifications

• 15+ years of clinical operations experience in biotech/pharma.
• Experience in rare diseases and/or CNS indications is strongly preferred.
• Significant experience advancing clinical programs from early development toward Phase 2/3 readiness.
• Proven experience leading global Phase 3 clinical trials.
• Strong strategic oversight of CROs, vendors, consultants, investigators, and clinical sites.
• Experience contributing to NDA, BLA, and/or MAA submissions.
• Demonstrated leadership experience, including building, managing, and mentoring clinical operations teams.
• Ability to proactively identify and resolve complex operational challenges.

Responsibilities

• Lead clinical operations strategy and execution across one or more programs from early development through pivotal trials.
• Oversee CROs, vendors, consultants, investigators, and clinical sites to ensure high-quality trials.
• Contribute to NDA, BLA, and/or MAA submissions and regulatory interactions.
• Mentor and develop clinical operations teams, building a high-performing organization.
• Identify and resolve complex operational challenges to maintain timelines and data quality.

Skills

Clinical Operations Leadership

Global Phase 3 Trials

CRO / Vendor Management

NDA / BLA / MAA Submissions

Mentoring Clinical Operations Teams

Early to Phase 2/3 Program Development

Rare Diseases / CNS Indications

Job description

Senior Director, Clinical Operations | Biotech

We are hiring a Senior Director of Clinical Operations on behalf of one of our small biotech clients.

In this role, you will lead clinical operations strategy and execution across one or more programs, from early clinical development through pivotal trials.

Key Experience & Qualifications:

• 15+ years of Clinical Operations experience within biotech/pharma.
• Experience in rare diseases and/or CNS indications strongly preferred.
• Significant experience advancing clinical programs from early development toward Phase 2/3 readiness.
• Proven experience leading global Phase 3 clinical trials.
• Strong strategic oversight of CROs, vendors, consultants, investigators, and clinical sites.
• Experience contributing to NDA, BLA, and/or MAA submissions.
• Demonstrated leadership experience, including building, managing, and mentoring clinical operations teams.
• Ability to proactively identify and resolve complex operational challenges

Our team will review applications and reach out to candidates whose experience aligns with the role.