Associate Director, Toxicology Study Monitoring

Job Description

General Summary:

The Associate Director of Toxicology Study Monitoring within Preclinical Sciences (PCS) is a (hybrid) leadership role accountable for the oversight and management of the Toxicology Study Monitoring team, planning activities for outsourced nonclinical studies across the portfolio, and resource/budget management for the group. In addition, the incumbent proposes strategic direction for the monitoring group in line with PCS deliverables, develops and implements best practices, and manages strategic vendor partnerships, key compliance aspects, and related sourcing initiatives. This strategic leader ensures the progression of clinical candidates from early discovery through development by partnering closely with other PCS Project Management & Strategic Operations staff, Early Research and Regulatory Safety Sciences, and key cross-functional team members. The Associate Director of Toxicology Study Monitoring is expected to provide clear and seamless communication, including status reporting, risk management, and escalation of issues to cross-functional stakeholders and Senior Management.

Key Duties & Responsibilities:

• Manage a highly effective internal Study Monitoring team and/or extended workforce by evaluating study monitor team workloads and ensuring optimal allocation of resources
• Serve as Study Monitor on key programs through routine monitoring of preclinical studies at CROs/partner organizations through on-site visits and remote interactions), reviews findings with project representatives, management, and other internal stakeholders including quality assurance
• Work closely with department leadership to maximize process efficiencies and align department goals and strategy
• Proactively identify areas of potential improvement, propose solutions, and lead high-priority study monitoring initiatives by defining goals and key milestones as well as reporting progress throughout the life of the initiative
• Lead interactions with key partner lines to advance the goals of the function
• Act as Study Monitoring liaison at internal leadership meetings and cross- functional team meetings, as well as external vendor collaboration/governance meetings
• Serve as subject matter expert (SME) in Study Monitoring across Preclinical Sciences and Research
• Accountable for quarterly overview of vendor metrics with QAU to determine vendor risk categorization
• Accountable for developing risk mitigation strategies with PSA, QAU and the vendor, ensuring the execution of these plans
• May represent Vertex at external conferences and other scientific meetings.

Knowledge and Skills:

• Comprehensive knowledge of preclinical drug discovery and development process through marketing and post-marketing phases
• Strong interpersonal, collaboration, and leadership/management skills
• Knowledge of Preclinical Regulatory process and filings
• Proactive and results-oriented self-starter, organized, and comfortable managing shifting priorities in a rapidly changing environment
• Developed communication acumen including excellent written, oral, and presentation skills as well as the ability to synthesize data/information into meaningful insights
• Ability to quickly establish credibility, rapport, and trust at all levels in order to influence across teams.
• Ability to manage multiple priorities/projects at a given time while meeting deadline and budget targets and providing regular status updates
• Ability to successfully execute project tasks in a fast-paced environment
• Experience in cross-functional execution including medium to large-scale projects; ability to effectively build consensus and alignment as well as communicate progress

Education and Experience:

• Master's Degree (or equivalent degree) in laboratory animal science, toxicology or other related scientific field and 8+ years of relevant employment experience, or
• Bachelor's Degree (or equivalent degree) in laboratory animal science, toxicology or other related scientific field and 10+ years of relevant employment experience
• Previous supervisory/managerial experience
• Experience in management of preclinical studies at CROs in regulated (GLP) and non-regulated (nGLP) environments
• Ability to travel up to 25%

Pay Range:

Disclosure Statement:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com