Deputy Head of Clinical Operations

Description:

The Deputy Head of Clinical Operations supports the strategic and operational leadership of clinical programs and trial execution across the organization. This role partners closely with the Head of Clinical Operations to ensure studies are delivered on time, within budget, and in compliance with regulatory requirements, Good Clinical Practice (GCP), and company quality standards.

The Deputy Head will provide support, and leadership as needed, to Clinical Operations teams, drive process improvements, oversee vendor performance, and contribute to organizational growth and operational excellence.

Location : Warren, New Jersey - Minimum 3 days a week on site

Salary Range : $240K - 275K

Key Responsibilities:

Clinical Trial Leadership & Execution

• Support the oversight and execution of global clinical trials from study start-up through closeout.
• Ensure clinical studies are conducted according to protocol, GCP, SOPs, regulatory requirements, and timelines.
• Manage departmental budget; effectively managing change orders and out of scope work
• Monitor study progress, enrollment, quality metrics, and operational risks.
• Collaborate with cross-functional teams including Clinical Development, Medical Affairs, Regulatory, Data Management, Biostatistics, and Pharmacovigilance.
• Act as deputy to the Head of Clinical Operations during periods of absence

Operational Strategy

• Assist in developing and implementing Clinical Operations strategies aligned with organizational objectives.
• Drive operational planning, resource allocation, and budget management for clinical programs.
• Identify risks and implement mitigation strategies to ensure successful study delivery.
• Contribute to portfolio planning and operational feasibility assessments .

Vendor & CRO Management

• Ensure vendor deliverables meet quality, timeline, and budget expectations.
• Participate in vendor selection, contracting, and governance processes.

Quality & Compliance

• Ensure inspection readiness across clinical programs.
• Support internal audits and regulatory inspections.
• Contribute to the development and maintenance of SOPs, processes, and quality systems.

Qualifications:

• Bachelor's degree in life sciences required; advanced degree (MS, PhD, PharmD) preferred
• 15+ years of clinical operations experience in biopharma or 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 skills
• Proven ability to manage CROs and external partners
• Strategic thinking with strong operational execution
• Ability to thrive in a fast-paced, evolving biotech environment
• Ability to balance strategic oversight with hands-on operational execution
• Strong problem-solving and decision-making capabilities
• Commitment to patient-centric clinical trial delivery
• Ability to influence across functions and levels

Behavioral skills:

• Curiosity: Keep on exploring uncharted territories. Always ask "why?" and more importantly "why not?",
• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,
• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,
• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.

Department Medical Locations US - Warren, NJ Remote status Hybrid Employment type Full-time