Sr. Director of Clinical Operation

Discover International; United States; On-site; USD 150,000 - 250,000; Full time

Job summary

A leading biotechnology firm is seeking a Senior Director of Clinical Operations to oversee strategic planning and execution of clinical trials. This executive role requires at least 5 years in clinical operations, particularly in nephrology and CRISPR-based therapies. Ideal candidates will possess strong leadership skills and a deep understanding of regulatory requirements. This full-time position promises a key role in driving innovative clinical strategies.

Qualifications

• Minimum 5+ years of experience in clinical operations within the biotech or pharmaceutical industry.
• Proven experience managing large, complex clinical trials.
• Deep knowledge of clinical development processes, regulatory guidelines, and GCP standards.

Responsibilities

• Lead the strategic planning, development, and execution of clinical trials.
• Oversee operational execution of clinical trials from initiation through completion.
• Serve as a key point of contact between clinical operations and external stakeholders.

Skills

Leadership

Strategic thinking

Team-building

Communication

Problem-solving

Education

Advanced degree (MD, PhD, or equivalent) in life sciences

Tools

Clinical trial management software

Job description

Senior Director of Clinical Operations

Position Overview:

The Senior Director of Clinical Operations will lead the strategic planning, development, and execution of clinical trials and operations across multiple therapeutic areas within the biotech industry. This senior leadership role will oversee the clinical operations team, ensuring the effective design, implementation, and management of clinical trials in compliance with regulatory requirements, industry standards, and corporate objectives. The ideal candidate will bring a global perspective, with substantial experience in nephrology and rare diseases for CRISPR-based editing therapies, as well as a proven ability to navigate the international clinical landscape and regulatory requirements.

Key Responsibilities:

Clinical Strategy Development:

• Develop and implement the clinical operations strategy in alignment with the overall business goals.
• Lead clinical operations teams in the planning and execution of clinical trials, including Phase I-IV studies, ensuring efficient use of resources and adherence to timelines.
• Provide expert guidance in the design, monitoring, and analysis of clinical trials across multiple platforms, particularly in nephrology and respiratory rare diseases.

Team Leadership and Management:

• Lead, mentor, and build a high‑performing clinical operations team, fostering a culture of collaboration, innovation, and accountability.
• Establish clear roles and responsibilities for the clinical operations team, ensuring alignment with cross‑functional teams such as regulatory, R&D, and project management.
• Provide ongoing performance feedback, coaching, and professional development to team members.

Clinical Trial Execution:

• Oversee the operational execution of clinical trials from initiation through completion, including site selection, recruitment, monitoring, and close‑out.
• Ensure trials are conducted in accordance with Good Clinical Practice (GCP), regulatory requirements, and internal SOPs.
• Manage external clinical vendors, including contract research organizations (CROs), clinical sites, and other third‑party partners, ensuring high‑quality performance and compliance.

Budget and Resource Management:

• Develop and manage budgets for clinical trials, ensuring efficient allocation of resources and maintaining cost control.
• Collaborate with finance and senior leadership to forecast budgets, assess risk, and ensure the timely execution of clinical projects within budget constraints.

Regulatory Compliance and Risk Management:

• Ensure all clinical trials comply with local and international regulatory requirements (e.g., FDA, EMA, ICH guidelines) and internal standards.
• Identify potential risks and develop strategies to mitigate them, ensuring trials stay on track with minimal disruptions.

Stakeholder Communication:

• Serve as a key point of contact between clinical operations, senior leadership, and external stakeholders, including investors and regulatory bodies.
• Present clinical trial progress, results, and challenges to executive leadership and the board of directors.

Innovation and Continuous Improvement:

• Stay current with industry trends, emerging technologies, and best practices in clinical operations to drive continuous improvement within the department.
• Champion the adoption of new tools and technologies to improve efficiency and quality in clinical operations.

Qualifications:

• Education:
• Advanced degree (MD, PhD, or equivalent) in life sciences, clinical research, or a related field.
• Experience:
• Minimum 5+ years of experience in clinical operations within the biotech or pharmaceutical industry, with at least 5 years in a senior leadership role.
• Proven experience managing large, complex clinical trials and leading cross‑functional teams, particularly in nephrology and rare disease and CRISPR‑based editing therapies.
• Deep knowledge of clinical development processes, regulatory guidelines, and GCP standards.
• Experience with clinical trial management software and tools, and proficiency in managing clinical trial budgets.
• Experience navigating the regulatory and clinical trial landscapes across different global regions, with an understanding of international requirements for rare disease trials.
• Skills and Competencies:
• Strong leadership, strategic thinking, and team‑building skills.
• Excellent communication, negotiation, and presentation skills.
• Ability to work in a fast‑paced, dynamic environment with shifting priorities.
• Strong problem‑solving skills, with a proactive, solution‑oriented mindset.
• High level of attention to detail and commitment to quality.

Seniority Level

• Executive

Employment Type

• Full‑time

Job Function

• Research

Industries

• Biotechnology Research and Pharmaceutical Manufacturing