Senior Director, Clinical Quality & Development Ops

About the Role

The Senior Director, Clinical Quality & Development Operations (CQDO) Good Clinical Practice (GCP) Compliance provides enterprise-level leadership and strategic oversight to ensure Global Clinical Operations (GCO) maintains a sustained state of GCP compliance. The role is accountable for embedding a proactive GCP compliance capability, provides strategic oversight and governance for GCO-owned Risk Management Plans (RMPs), clinical site holds and closures, Quality Risks, and Serious Breach assessments. This ensures proactive risk identification, regulatory compliance, and effective quality risk mitigation across the clinical development portfolio. Through leadership of a high-performing CQDO team, this role ensures quality and compliance are consistently aligned with GCO objectives and broader corporate strategy.

Responsibilities

• Lead Quality Event Management activities related to the investigation, root cause analysis, and development of corrective action/preventive action plans for GCO-assigned events, including unplanned deviations, corrective/preventive actions, and effectiveness checks, ensuring timelines for closure are met.
• Participate in GCP Event Action Committees (EAC’s) as needed.
• Lead the development and oversight of GCO-owned Risk Management Plans (RMPs), site hold and closure activities, Quality Risks, and Serious Breach assessments, driving quality governance, risk-based decision-making, and inspection readiness throughout the clinical trial lifecycle.
• Ensure consistency in processes throughout all functions in Global Clinical Operations and develop methods for continuous process improvement.
• Analyze risks for readiness and manage the implementation of readiness programs, developing lessons learned after each inspection.
• Develop strategy with Global Clinical Operations in the development of CAPA plans and investigations in response to audits and inspections. Ensure inspection findings are remediated and processes are implemented within GCO.
• Oversee the development and implementation of quality frameworks, operational standards, and risk mitigation strategies across clinical programs, with a focus on harmonizing global processes and ensuring compliance with regulatory requirements.
• Provide advanced leadership and execution of business strategy, leveraging knowledge of the potential future stakeholder landscape to support the pipeline and identify influential stakeholders, both internal and external.
• Champion well-founded perspectives with authority and strategic insight, inspiring stakeholder confidence and securing buy-in, even when navigating complex, unfamiliar, or contentious subject matter.
• Demonstrate exceptional leadership by fostering open dialogue, addressing divergent opinions constructively, and driving consensus to advance organizational objectives.
• Lead the conception and implementation of transformative solutions that proactively address dynamic business challenges, ensuring alignment with industry standards and regulatory requirements.
• Foster a forward-thinking approach by driving innovation, cross-functional collaboration, and embedding quality and compliance into every stage of solution development.
• Identify and resolve technical and operational problems, understanding the broader impact on the department.
• Provide strategic input to solve complex problems while exercising judgment using multiple sources of information.
• As a people manager, may have financial accountabilities and human resource responsibilities for assigned staff.

Requirements

• Expert ability to leverage knowledge of organizational goals and interdependencies with other functional areas to drive success.
• Expert understanding of GCP, CFR, and ICH guidelines and Health Authority regulations.
• Lead cross-functional projects of high complexity with cross-functional team members and represent Clinical Quality & Development Operations on other large-scale projects/initiatives.
• Develop strategy for their domain in alignment with Clinical Quality & Development Operations (CQDO), Global Clinical Operations, and Global Medicines Development & Medical Affairs program strategy and goals.
• Lead major projects in support of GCO infrastructure and make department-wide decisions.
• Extensive Global Clinical Operations/Clinical Development experience in multiple therapeutic areas.
• Exceptional strategic vision and leadership capabilities.
• Expert knowledge in system/technical tools and processes.
• Demonstrated attention to detail, accuracy, excellent review, and analytical skills in a fast-paced environment.
• Results-oriented with excellent leadership and interpersonal skills, and an ability to effectively work and problem-solve within a multidisciplinary team.
• Excellent verbal and written communication and presentation skills.
• Excellent analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision-making.
• Expertise in drug development, operations, and resource/budget planning across global geographies.
• Knowledge of emerging technologies and trends.
• Ability to drive innovation and excellence.
• Proven strong business acumen.
• Excellent project management, critical thinking, and problem-solving skills.
• Demonstrated adaptability, flexibility, independence, and resourcefulness to thrive in a mid-sized company environment.

Qualifications

• Bachelor of Science degree in a life sciences discipline.
• Typically requires 15 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry.
• 5 years of supervisor/management experience.

Pay

The pay range for this role is $222,200 - $333,200. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on skills, competencies, experience, and other job-related factors permitted by law.

Benefits

• Inclusive market-leading benefits to meet employees wherever they are in their career, financial, family, and well-being journey.
• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the Summer and Winter.
• Educational assistance programs, including student loan repayment.
• Generous commuting subsidy.
• Matching charitable donations.
• 401(k) retirement plan.

Schedule

This is a Remote-Eligible Flex role. You can choose to be designated as:

• Remote: Work remotely five days per week and come into the office on occasion.
• Hybrid: Work remotely up to two days per week.
• On-Site: Work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.