The Senior Director, Head of Technology – Early Development, will be responsible for the overall technology strategy, project management, and application support & development for the Therapeutic Development and [Clinical] Supply business function of Johnson and Johnson Innovative Medicines This is a critical leadership role in the Research Systems organization, supporting Discovery and Early Development, an organization that exists to enable a next-generation R&D ecosystem that is highly automated, software-defined, data-centric and AI-augmented

• Our remit is to remove repetitive manual work, ensure data is FAIR, and architect information and compute so every digital tool, assay and process connects end-to-end
• By providing scalable compute, robust data fabrics and integrated digital workflows across discovery, CMC and clinical supply

In a business partnering capacity this role will be engaged across scientific functions including for both Synthetics Product and Process Development, Biotechnology Product and Process Development, Drug Delivery Device Development and Clinical Supply including operational support for R&D Pilot plants to enable, accelerate and amplify the work of the CMC and Clinical Supply Engine to deliver the J&J IM Pipeline Partnering with scientific functions, this role will lead and contribute to matrixed teams alongside Data Science & Digital Health and cross-functional technology partners: Engineering, Laboratory Systems, Enterprise Architecture, Information Security & Risk, and Technology Services You will focus on innovative and evolving capabilities and talent, and direct the strategy, architecture, build and operations of technology products to support the 1) diverse laboratory and pilot plant network operated by the TDS Organization and 2) Data and Analytics products that are driven by the product, process development, and manufacturing data

• Responsibility for both people (direct and/or indirect) as well as systems and projects
• Lead a team of about 5-8 direct reports as a people leader, along with 15 - 20 indirect employees and contractors
• Report on the progress of workstreams/capabilities within scope of responsibility
• Roles on the overall leadership team of the Research Systems SLT
• Develop a future roadmap for systems or capability areas within areas of responsibility and ensure the technical approaches and capabilities solutions are in-line with technical/business strategy
• Complete understanding and experience working within and leading an Agile development team
• Accountable for the day-to-day operation of Therapeutic Development and Supply Systems

In partnership with Suppliers and Technology Services, ensuring that all tickets are resolved within SLA and change management processes are followed as defined in change management procedure and platformed is patched and upgraded to supported level

• Lead within the framework of established policies and procedures with accountability for all systems and their improvements
• Provide evaluation and cost estimation for all projects, enhancements and roll outs, including understanding of the business’s needs and priorities and provide system expertise
• Lead build testing and production delivery for all relevant projects, enhancements and roll outs
• Build implementation plans for relevant initiatives including timeline, owner, and key milestones
• Coordinate with business partner’s prioritization of the projects based on business value and risk compliance to improve ROI

Understand core internal IT products and drive business value by working with Suppliers like: Biovia, Revvity, Benchling, PAS-X, NGENCODAC, OMP, IVRS and other vendors to gain understanding of future capabilities/improvement and their potential applicability within the J&J IM R&D environment

• Understand technology landscape within scope of responsibility, seek internal and external insights to craft technology approach and vision
• Analyze business problems, opportunities, and challenges, factoring in a deep understanding of the technical architecture and the underlying drivers of the business
• Design technical solutions at scale, including system integrations, in partnership with other sub-functions in IT

Assist in structuring and executing Proof of Concepts and plans to scale and integrate in the broader system landscape

• A PhD and demonstrable expertise in CMC is an advantage
• A minimum of 10-years of IT experience is required, along with a minimum of 5-years of experience leading others
• Working knowledge of drug development, GMP manufacturing and supply
• Proven experience in several of the following:
• FAIR data management
• Laboratory & plant data automation
• Intelligent automation of AI/ML training & deployment
• Provisioning scalable, efficient & cost-effective high-performance compute
• Must possess knowledge of process engineering data models and integration solutions
• A proven track record of project delivery and business relationship management
• Understanding of R&D development, particularly small molecule development and processes
• Ability to translate business requirements into technology solutions
• Strong leadership skills – operate as an independent leader with understanding and appreciation of the global/enterprise context
• Strong consultative and facilitation skills required
• Strong presentation skills – ability to speak across various forums and communicate to s broad, diverse audience required
• Prior experience in therapeutics development AND pharmaceutical supply chain and associated IT systems within the pharmaceutical or biotechnology industry

Up to 15% domestic and international travel will be required

• Experience with large scale portfolio clinical, clinical data warehouse and/or clinical operations technologies such as Biovia, Revvity, Benchling, Genedata, Korber, OMP, IVRS

Budget Management, Business Case Modeling, Business Requirements Analysis, Corporate Management, Developing Others, Emerging Technologies, Gap Analysis, Global Market, Inclusive Leadership, Leadership, Operational Excellence, Process Improvements, Product Improvements, Product Lifecycle Management (PLM), Product Management, Product Strategies, Quality Assurance (QA), Strategic Thinking, Technical Credibility