Executive Director, Global Clinical Operations

Nuvation Bio; San Francisco (CA); On-site; USD 300,000 - 520,000; Full time

Benefits offered by this job

Competitive base salary + bonus +equty

Unlimited vacation + 10 sick days

Excellent medical, dental, vision

401K with company matching

Job summary

Nuvation Bio is seeking a driven Vice President of Clinical Operations to lead the Global Clinical Operations team within the Clinical Research and Development organization in San Francisco. You will develop and execute trial plans, drive operational excellence, and collaborate with senior leaders to set strategy and ensure timely, compliant delivery across programs.

You’ll shape risk management, oversee budgets, and supervise cross-functional teams, including CROs and internal stakeholders, to

Qualifications

• 15+ years of pharmaceutical clinical drug development experience, with 7-8 years minimum in global clinical trial management with direct team leadership and management
• Minimum Degree: Bachelor’s degree or equivalent or any relevant and qualifying training education/background in biological sciences or in healthcare
• Ability to coach and lead senior leaders within their own organization and support their career development and success
• Track record of building strong relationships with executive leadership with the ability to influence and impact key decisions at the strategic level
• Demonstrated senior leadership and accomplishment in all aspects of conducting global clinical trials and programs in Oncology
• Significant and close collaboration with Phase 1 investigators in Oncology
• Extensive knowledge of clinical development process, regulatory requirements, translational operations, and Good Clinical Practice (GCP)
• Prior global experience and ability to establish international Clinical Operations strategic plans to reach eligible patient populations and sustain rapid enrollment for programs
• Proven track record in trial management process improvements
• Strong senior leadership, interpersonal and problem-solving skills
• Excellent communication, organization, and tracking skills with involvement in cross-functional, multicultural/international teams

Responsibilities

• Leads the global clinical operations team to execute on Nuvation Bio’s clinical trial programs
• Attracts, develops, coaches, and retains high-performance team members, creating a culture of collaboration with an emphasis on performance, continuous learning and career development
• Works with team members to develop systems to ensure consistent, high-quality project management
• Ensures strategic planning, execution, and operational delivery of clinical trials across all programs working in collaboration with cross-functional partners
• Leads planning and management of the clinical programs from an end-to-end trial management perspective to achieve Clinical R&D team objectives
• Shapes the Clinical Operations strategy and translates the strategy into an operational risk management plan by identifying and appropriately escalating trial and program risks to the Clinical R&D leadership team and the Executive Committee
• Acts as Clinical Operations representative at Executive Committee meetings as appropriate
• In collaboration with Medical Writing, writes and/or oversees authorship of clinical operation sections of regulatory documents, including protocols, Investigator Brochures, annual reports, CDPs, and other documents as needed
• Works with the cross-functional Clinical R&D teams in support of regulatory submissions and interactions
• Identifies clinical program/resource gaps, performs project risk analyses, recommends solutions and implements action plans to mitigate risk
• Develops and maintains relationships with clinical investigators, consultants, external service providers and leaders/members of other Nuvation Bio departments
• Works with Clinical Operations team on CRO/vendor qualification and selection processes for outsourced activities, including scope of services agreements, budgets with unit cost negotiation, clinical and translational operational plans, and detailed timelines, and ensure that high-performance expectations are met
• Focuses on Quality to establish and maintain a state of inspection-readiness
• Oversees life cycle budget, including forecast, multi-year cost targets, and annual cost targets for all trials
• Ensures optimal resourcing across trials to meet business needs according to portfolio prioritization. Includes coordination of headcount requests and resource alignment with other line functions
• Leads the development of department processes and best practices, including review of Standard Operating Procedures (SOPs) and development of standard reports, templates, and forms
• Develops and implements operational program-specific standards as required to enhance consistency across trials

Skills

Leadership

Team Leadership

Strategic Thinking

Cross-functional Collaboration

Communication

Problem Solving

Adaptability

Accountability

Stakeholder Influence

Education

Bachelor's degree in biological sciences/healthcare

Job description

Nuvation Bio is seeking a driven Vice President of Clinical Operations to lead the Global Clinical Operations team within the Clinical Research and Development organization in San Francisco. You will develop and execute trial plans, drive operational excellence, and collaborate with senior leaders to set strategy and ensure timely, compliant delivery across programs.

You’ll shape risk management, oversee budgets, and supervise cross-functional teams, including CROs and internal stakeholders, to