Director, Clinical Operations

Scorpion Therapeutics; San Diego (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior leader to manage Clinical Operations across all phases of clinical development. You will design strategic plans, oversee CROs and vendors, and coordinate with Regulatory and QA to ensure studies meet timelines, budgets, and regulatory requirements.

The role focuses on leadership, mentorship, and cross-functional collaboration to advance rare/endocrine disease programs.

Qualifications

• BS/BA in scientific/related field with 12+ years clinical research experience including ICH/GCP/FDA/EU
• Master’s/MBA + 10+ years similar experience OR extensive managerial experience
• Detailed knowledge of clinical drug development (ICH/GCP/FDA/EU)

Responsibilities

• Design and implement clinical strategies using internal and external resources
• Provide leadership to the Clinical Operations study team
• Lead tactical implementation and execution of the clinical development process (all phases) for selected programs
• Ensure activities comply with FDA/EU/ICH and corporate/departmental SOPs
• Establish and manage clinical program and individual study budgets
• Develop and maintain clinical trial timelines to achieve corporate goals
• Create and benchmark critical metrics; drive process improvements
• Manage CRO/vendor relationships and act as point of contact with external bodies
• Coordinate with Regulatory, QA, and other functions; support cross-functional meetings and documentation
• Provide operational input to clinical protocols, development plans, and clinical study reports
• Recruit, train, and manage direct reports
• Manage operational activities with corporate partners

Skills

Leadership

Strategic planning

Vendor management

Cross-functional collaboration

Mentoring

Global study leadership

Regulatory knowledge

Budget management

Influencing/negotiation

Education

BS/BA in scientific field

Master’s/MBA

Job description

About The Role

Responsible for developing strategic plans, objectives, and overall management for the Clinical Operations team executing Neurocrine’s clinical studies (all phases). Ensure clinical study activities are conducted in compliance with FDA regulations, EU Directive, ICH guidelines, and adherence to corporate/departmental Standard Operating Procedures. Oversee CROs, external vendors, and internal stakeholders to ensure studies meet timelines, budgets, and resources. Manage career development for multiple direct reports.

Your Contributions

• Design and implement clinical strategies using internal and external resources
• Provide leadership to the Clinical Operations study team
• Lead tactical implementation and execution of the clinical development process (all phases) for selected programs
• Ensure activities comply with FDA/EU/ICH and corporate/departmental SOPs
• Establish and manage clinical program and individual study budgets
• Develop and maintain clinical trial timelines to achieve corporate goals
• Create and benchmark critical metrics; drive process improvements
• Manage CRO/vendor relationships and act as point of contact with external bodies
• Coordinate with Regulatory, QA, and other functions; support cross-functional meetings and documentation
• Provide operational input to clinical protocols, development plans, and clinical study reports
• Recruit, train, and manage direct reports
• Manage operational activities with corporate partners

Requirements

• BS/BA in scientific/related field + 12+ years clinical research experience (pharma/biotech or CRO) including ICH/GCP/FDA/EU; prior global study leadership (endocrine and/or rare diseases) OR
• Master’s/MBA + 10+ years similar experience OR extensive managerial experience
• Detailed knowledge of clinical drug development (ICH/GCP/FDA/EU)
• Ability to manage/mentor/train, influence, and motivate
• Expertise directing global studies (endocrine and/or rare diseases)
• Strategic vendor management (CROs)
• Strong leadership, organizational, negotiation/influencing skills, and ability to work in a matrix environment