Business Engagement & Technology, Associate Director - Clinical & Early Development
PharmaBiotechRegulatory AffairsQuality Assuranceemacroinform
Job description
Job Description General Summary: The Business Engagement Lead role within DTE to support our Clinical Development and Early Development business function role serves as a strategic partner between the business and DTE, translating business priorities into scalable, compliant, and fit-for-purpose systems, processes, and digital solutions. The Associate Director will work closely with business leaders and subject matter experts to understand priorities, shape capability roadmaps including AI related business use cases, and drive delivery of solutions that improve how our development organizations work. This role requires strong relationship management, business process acumen, and the ability to lead across a complex, matrixed, and regulated environment. Key Duties and Responsibilities: Serve as the primary DTE business engagement lead for Clinical Development and Early Development Partner with business leaders and subject matter experts to understand priorities, challenges, and capability needs Translate business needs into scalable systems, workflows, and digital solutions Shape and manage demand intake, prioritization, and roadmap planning across supported functions Identify opportunities to improve business processes, user experience, and operational effectiveness Support and evolve business capabilities across Early Development, including Translational Medicine and related scientific teams Collaborate with product, engineering, data, analytics, quality, security, and compliance teams to deliver aligned solutions Support business case development, process improvements, and system enhancement planning Ensure solutions align with regulatory, governance, validation, security, and quality expectations Drive stakeholder alignment, change management, adoption, and continuous improvement Communicate plans, risks, dependencies, and outcomes to senior leaders and cross-functional stakeholders. Knowledge and Skills: Bachelor’s degree, Master's degree and/or MBA in life sciences, business, information systems, computer science, engineering, or a related field Typically 10+ years of relevant experience in business engagement, business relationship management, IT/DTE business partnering, product management, or similar roles Experience supporting Clinical Development and/or Early Development functions within biotechnology, pharmaceutical, or life sciences organizations Experience delivering AI business use cases to expedite business operations reducing overall submission timelines Demonstrated experience designing, implementing, enhancing, or supporting systems and business processes that enable development organizations, including Translational Medicine capabilities Experience supporting or partnering on platforms used in clinical pharmacology, quantitative pharmacology, pharmacometrics, or modeling and simulation environments Familiarity with systems such as Metworx, Certara Phoenix, PK/PD data environments, and related modeling and simulation tools Experience supporting systems and business processes that enable Early Development activities in First-in-Human studies Experience gathering business requirements and translating them into scalable systems, workflows, and operating processes Strong understanding of business workflows, operational capabilities, and data needs across development functions Experience leading cross-functional initiatives involving business, product, engineering, data, quality, and compliance stakeholders Strong communication, facilitation, stakeholder management, and executive presentation skills Demonstrated ability to influence across a matrixed organization and drive execution in a dynamic environment Experience working in regulated environments with strong attention to compliance, governance, validation, and quality Advanced degree such as MBA, MS or other relevant graduate degree Experience supporting roadmap development, capability assessments, and business transformation initiatives Experience working in global biotechnology or pharmaceutical organizations Preferred Qualification: Experience with Agile, product operating models, or other structured delivery methodologies Experience supporting roadmap development, capability assessments, and business transformation initiatives #LI-hybrid #LI-JS1 At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients. Pay Range: $164,400 - $246,600 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 know
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