Senior Director, Global Clinical Operations and Medical Writing Technology

Bristol Myers Squibb

$228K — $342K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree and 10+ years of relevant work experience
  • Direct experience with biotechnology and/or pharmaceutical systems
  • Hands-on expertise with AI solutions and organizational change management
  • In-depth knowledge of biotech industry regulations such as 21 CFR Part 11
  • Expertise in project management, resource management, and system lifecycle management
  • Strong communication and interpersonal skills
  • Solid analytical and problem-solving abilities

Responsibilities

  • Partner with stakeholders in Clinical Operations and Medical Writing to manage the AI technology portfolio
  • Build and maintain trusted relationships with key business leaders
  • Present strategic ideas to cross-functional senior leaders regularly
  • Develop multi-year technology roadmaps to deliver impactful outcomes
  • Lead a team of 5 plus managed services staff for project oversight
  • Oversee project quality, budget, and delivery timelines
  • Propose innovative tools/technologies to drive efficiency and business process improvements

Benefits

  • Inclusive market-leading medical, dental, and vision benefits
  • Generous paid time off, including a company shutdown week
  • Educational assistance programs and student loan repayment options
  • Commuting subsidy and matching charitable donations
  • 401(k) plan and additional wellness resources
Full Job Description

Job Description

General Summary:

The Senior Director, GlobalClinical Operations and Medical WritingTechnology will lead a team responsible for planning, architecture, design, development, support,maintenanceand future roadmaps for systems supportingclinical operations and medical writingteams 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 deliverdigital and Artificial Intelligence (AI)solutions in support of their goals and objectives.

Key Duties and Responsibilities:

  • Partner with business stakeholders acrossGlobal Clinical Operations and Medical Writingteams to manage and prioritize thedigital and AItechnology 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 of5Vertex team members, plus a managed services team of support engineers, administrators, and analysts

  • Oversee a portfolio of projects, programs,releasesand system enhancements, assuring quality and timeliness of delivery whileremainingwithinallocatedbudget limits

  • Proactively offer innovativenew tools/technologiesfor consideration, AIsolution 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, platformreleasesand 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 asVeevaVaultClinical Trial Management System (CTMS), VeevaElectronic Trial Master File (eTMF), andElluminateElectronic Data Capture (EDC)platform,ensuringmaximumuptime, high performance, and excellent customer service

  • Work closely with Information Security and Quality Assurance groups as needed to ensure compliance withGxPregulations, 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 ofclinical operations and medical writing

  • Hands-onexpertisewith identifying AI opportunities, deployingAgentic/Gen AIsolutions, andleading/supportingAI focusedorganizational change management and trainingfor business partners

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

  • Program/ project management, demand management, resourcemanagementand system life cycleexpertise

  • 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:

  • Bachelors 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,enhancementsand operational support procedures

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

  • ITfinancial managementexperience, 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 Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

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