Senior Director, Clinical Operations

Overview

About Certara

Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.

Our goal is to enable the life sciences industry’s use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization.

The Senior Director for clinical operations will provide leadership for strategic projects by ensuring that there is strong alignment between strategy, goals, and implementation. May or may not have direct reports.

Responsibilities

• Leads Certara Clinical Operations and Study Management activities.
• Leads CRO/vendor selection process for outsourced activities, including development of scope of services agreements, budgets, plans and detailed timelines.
• Works with Certara team and sponsors to select CROs, train investigators and investigative site staff, preparation of materials for investigator meetings, and clinical supplies as applicable.
• Work with Certara QA to review CRO Quality Systems and perform audits as required.
• Participate and prepare for regulatory and/ or client audits when scheduled.
• Leads (or is a member of) Certara's study management team (SMT).
• Drives (or supports SMT lead) in the development and review of study planning to meet client objectives (including timelines, metrics, and budgets).
• Responsible for providing sponsor oversight of Phase 1 clinical study conduct (start-up through database lock and reporting), including review of study documents and coordinating cross-functional efforts to achieve study objectives and goals with a focus on quality.
• Ensure sponsor and CRO aspects of clinical studies run by Certara on behalf of clients are conducted in compliance with SOPs, Agency regulations, ICH/GCP guidelines and applicable local laws.
• Provide oversight of activities associated with the implementation, management and oversight of clinical trials.
• Provides training to internal and external customers as needed.
• Participate and provide expert clinical operations input into the writing of key clinical study documents including protocols and amendments, Informed Consent Forms, Investigator Brochures (IB) and Investigational New Drug Applications (INDs), providing guidance on operational and logistical issues.
• Identifies and communicates in a timely manner study issues that will impact budget, resources and timelines.
• Reviews and critiques case report forms/eCRFs for accuracy and completeness.
• Oversees data discrepancy management and assists with mapping as needed.
• Manages all aspects of vendor relationships to achieve project goals and ensure that performance expectations are met.
• Manages vendor agreements, change orders and site budgets to meet clinical operations specifications.
• Responsible for review of invoices for accuracy compared to work known to be performed by the vendor.
• Ensures that supportive study documents are completed with a focus on quality.
• Assist in the preparation of clinical study reports.
• In collaboration with QA, develop clinical operations quality systems, including standard operating procedures, document management, clinical operations personnel training, and quality control processes.
• Contributes to wider organizational goals and/or activities as assigned.
• Communication
• Collaborate directly with sponsors and stakeholders in developing business requirements, business controls and implementation plans.
• Communicate issues, issue status, and issue resolution on a regular basis to appropriate team members.
• Provide leadership and timely feedback to keep all stakeholders, including senior management, informed of project progress.

Qualifications

• Bachelor's degree required; science base education preferred; minimum of fifteen years related experience in the CRO, pharmaceutical or biotechnology industry, including at least 5 years of early development, Phase I CPU experience preferable.
• Previous experience managing direct reports is a plus.
• Self-starter with expertise in Phase 1 drug development, operations, and strategic planning.
• Effective leadership skills and ability to foster team productivity and cohesiveness.
• Experience leading multi-disciplinary teams and mentoring clinical team members.
• Knowledge of clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.
• Knowledge of Clinical Trial Regulatory requirements in USA and EMA (Australia a bonus).
• Experience managing Clinical Trial Supply in collaboration with manufacturer and CRO.
• Experience developing or reviewing SOPs.
• Experience managing CROs, central laboratories, and other clinical vendors.
• Experience managing contracts (vendor and site) and finance activities.
• Knowledge of data management, data review/analysis, and pharmacovigilance requirements.
• Familiarity with project planning tools and task dependencies.
• Skills & Abilities
• Ability to prioritize and manage multiple concurrent tasks in a fast-paced deadline driven environment while delivering high quality results.
• Ability to write clearly and summarize information effectively.
• Ability to solve complex problems and manage multiple tasks simultaneously.
• Strong communication and interpersonal skills.
• Self-motivated with strong attention to detail and analytical problem-solving skills.
• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint, MS Project, Teams) and SharePoint.
• Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

Responsibilities

• Leads Certara Clinical Operations and Study Management activities.
• Leads CRO/vendor selection process for outsourced activities, including development of scope of services agreements, budgets, plans and detailed timelines.
• Works with Certara team and sponsors to select CROs, train investigators and investigative site staff, preparation of materials for investigator meetings, and clinical supplies as applicable.
• Work with Certara QA to review CRO Quality Systems and perform audits as required.
• Participate and prepare for regulatory and/ or client audits when scheduled.
• Leads (or is a member of) Certara's study management team (SMT).
• Drives (or supports SMT lead) in the development and review of study planning to meet client objectives (including timelines, metrics, and budgets).
• Responsible for providing sponsor oversight of Phase 1 clinical study conduct (start-up through database lock and reporting), including review of study documents and coordinating cross-functional efforts to achieve study objectives and goals with a focus on quality.
• Ensure sponsor and CRO aspects of clinical studies run by Certara on behalf of clients are conducted in compliance with SOPs, Agency regulations, ICH/GCP guidelines and applicable local laws.
• Provide oversight of activities associated with the implementation, management and oversight of clinical trials.
• Provides training to internal and external customers as needed.
• Participate and provide expert clinical operations input into the writing of key clinical study documents including protocols and amendments, Informed Consent Forms, Investigator Brochures (IB) and Investigational New Drug Applications (INDs), providing guidance on operational and logistical issues.
• Identifies and communicates in a timely manner study issues that will impact budget, resources and timelines.
• Reviews and critiques case report forms/eCRFs for accuracy and completeness.
• Oversees data discrepancy management and assists with mapping as needed.
• Manages all aspects of vendor relationships to achieve project goals and ensure that performance expectations are met.
• Manages vendor agreements, change orders and site budgets to meet clinical operations specifications.
• Responsible for review of invoices for accuracy compared to work known to be performed by the vendor.
• Ensures that supportive study documents are completed with a focus on quality.
• Assist in the preparation of clinical study reports.
• In collaboration with QA, develop clinical operations quality systems, including standard operating procedures, document management, clinical operations personnel training, and quality control processes.
• Contributes to wider organizational goals and/or activities as assigned.
• Communication
• Collaborate directly with sponsors and stakeholders in developing business requirements, business controls and implementation plans.
• Communicate issues, issue status, and issue resolution on a regular basis to appropriate team members.
• Provide leadership and timely feedback to keep all stakeholders, including senior management, informed of project progress.

Qualifications

• Bachelor's degree required; science base education preferred; minimum of fifteen years related experience in the CRO, pharmaceutical or biotechnology industry, including at least 5 years of early development, Phase I CPU experience preferable.
• Previous experience managing direct reports is a plus.
• Self-starter with expertise in Phase 1 drug development, operations, and strategic planning.
• Effective leadership skills and ability to foster team productivity and cohesiveness.
• Experience leading multi-disciplinary teams and mentoring clinical team members.
• Knowledge of clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.
• Knowledge of Clinical Trial Regulatory requirements in USA and EMA (Australia a bonus).
• Experience managing Clinical Trial Supply in collaboration with manufacturer and CRO.
• Experience developing or reviewing SOPs.
• Experience managing CROs, central laboratories, and other clinical vendors.
• Experience managing contracts (vendor and site) and finance activities.
• Knowledge of data management, data review/analysis, and pharmacovigilance requirements.
• Familiarity with project planning tools and task dependencies.
• Skills & Abilities
• Ability to prioritize and manage multiple concurrent tasks in a fast-paced deadline driven environment while delivering high quality results.
• Ability to write clearly and summarize information effectively.
• Ability to solve complex problems and manage multiple tasks simultaneously.
• Strong communication and interpersonal skills.
• Self-motivated with strong attention to detail and analytical problem-solving skills.
• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint, MS Project, Teams) and SharePoint.
• Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.