Senior Director, Global Clinical Operations and Medical Writing Technology

Job Description

General Summary:

The Senior Director, Global Clinical Operations and Medical Writing Technology will lead a team responsible for planning, architecture, design, development, support, maintenance and future roadmaps for systems supporting clinical operations and medical writing teams at Vertex.  The incumbent will collaborate with senior leaders and other key stakeholders across these areas of the business, as well as peers across the Data, Technology and Engineering (DTE) organization, to identify, prioritize, design and deliver digital and Artificial Intelligence (AI) solutions in support of their goals and objectives. 

Key Duties and Responsibilities: 

• Partner with business stakeholders across Global Clinical Operations and Medical Writing teams to manage and prioritize the digital and AI technology portfolio and continually build the future roadmap 

• Build and strengthen relationships with key stakeholders - become a trusted partner and have an ongoing, significant impact towards meeting strategic business goals 

• Present ideas and forward-looking plans to, and engage directly with, cross-functional senior leaders on regular basis 

• Develop multi-year leadership-driven technology roadmaps delivering valued outcomes 

• Direct and lead a group of 5 Vertex team members, plus a managed services team of support engineers, administrators, and analysts 

• Oversee a portfolio of projects, programs, releases and system enhancements, assuring quality and timeliness of delivery while remaining within allocated budget limits 

• Proactively offer innovative new tools/technologies for consideration, AI solution ideas, and potential business process improvements in pursuit of driving efficiencies and meeting business needs 

• Enhance and improve internal processes and procedures related to demand management, resource management, project delivery, platform releases and ongoing operational support 

• Manage relationships with our strategic software vendors and service providers 

• Provide day-to-day support and maintenance for business-critical applications such as Veeva Vault Clinical Trial Management System (CTMS), Veeva Electronic Trial Master File (eTMF), and Elluminate Electronic Data Capture (EDC) platform, ensuring maximum uptime, high performance, and excellent customer service 

• Work closely with Information Security and Quality Assurance groups as needed to ensure compliance with GxP regulations, as well as our DTE system lifecycle and change management requirements 

Knowledge and Skills:            

• Direct experience with biotechnology and/or pharmaceutical systems, particularly in the areas of clinical operations and medical writing 

• Hands-on expertise with identifying AI opportunities, deploying Agentic/Gen AI solutions, and leading/supporting AI focused organizational change management and training for business partners 

• In-depth knowledge of the biotech industry, including specific regulations such as 21 CFR Part 11 and Good Clinical Practices (or other GxP areas) 

• Program/ project management, demand management, resource management and system life cycle expertise 

• Strong communication, interpersonal and collaborative skills 

• Solid analytical and problem-solving abilities 

• Excellent verbal, written, and presentation skills to influence technical and non-technical audiences 

Education and Experience: 

• Bachelor’s degree and 10+ years relevant work experience 

• Biotech or pharmaceutical industry experience 

• Experience managing implementation partners and managed services/ offshore teams 

• Deep experience with enterprise applications and SaaS implementations, upgrades, enhancements and operational support procedures 

• In-depth experience in design, development, and deployment of technology solutions using agile software development practices 

• IT financial management experience, managing budgets and forecasts across operational expenses and new investments 

Pay Range:

$228,000 - $342,000

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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 a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    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. 

#LI-Hybrid
 

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