Deputy Head of Clinical Operations

Key Responsibilities
- Support oversight and execution of global clinical trials from study start-up through closeout.
- Ensure studies are conducted per protocol, ICH-GCP, SOPs, regulatory requirements, and timelines.
- Manage departmental budget, including change orders and out-of-scope work.
- Monitor study progress, enrollment, quality metrics, and operational risks.
- Collaborate cross-functionally with Clinical Development, Medical Affairs, Regulatory, Data Management, Biostatistics, and Pharmacovigilance.
- Act as deputy to the Head of Clinical Operations during periods of absence.
- Assist in developing and implementing Clinical Operations strategies aligned with organizational objectives.
- Drive operational planning, resource allocation, and budget management.
- Identify risks and implement mitigation strategies.
- Contribute to portfolio planning and operational feasibility assessments.
- Ensure vendor deliverables meet quality, timeline, and budget expectations.
- Participate in vendor selection, contracting, and governance.
- Ensure inspection readiness; support internal audits and regulatory inspections.
- Contribute to development and maintenance of SOPs, processes, and quality systems.

Qualifications
- Bachelor’s degree in life sciences required; MS/PhD/PharmD preferred.
- 15+ years of clinical operations experience in biopharma/life sciences.
- Significant experience managing global clinical trials across multiple phases.
- Prior leadership experience (people management required).
- Experience in immunology, allergy, or rare disease strongly preferred.
- Deep knowledge of ICH-GCP and global regulatory requirements.
- Strong leadership, communication, and stakeholder management; proven ability to manage CROs and external partners.
- Strategic thinking with strong operational execution; thrive in fast-paced, evolving biotech.

Location: Warren, New Jersey (minimum 3 days/week on site). Salary range: $240K–275K.