Digital Transformation Leader, PTDS
South San Francisco, CA

Job Description

The Digital Transformation Leader will be responsible for setting the strategic vision for digital enhancements in clinical supply, will oversee a portfolio of digital capabilities and may lead various projects to roll out new digital capabilities. The incumbent will act as the liaison between Clinical Operations and the Clinical Supply organization related to digital offerings by Clinical Supply across the clinical trial space. He/she will lead assessments of new technologies and as appropriate will lead the roll out of new capabilities. The successful candidate will be responsible for leading transformation that contributes significantly to the goals and objectives of PTD(S).

Job Responsibilities

* Serve as primary consultant for senior management and as the internal/external spokesperson for PTDS related to digital capabilities and options available in the clinical setting.
* Influence the development of objectives and long-range goals related to the application of technologies to enhance clinical trial design, speed, adherence, and effectiveness for Roche / Genentech.
* Manage a portfolio of digital capabilities and systematically prioritize the opportunities
* Establish a digital transformation strategy working directly with the Clinical Trial Supply Leadership team that leverages cutting edge capabilities available through Industry 4.0; these options may span packaging design, push and pull of information to smart devices, the latest in chip technologies, software, and hardware offerings.
* Partner and collaborate globally with leaders in Clinical Operations from gRED, pRED, and PDG to identify areas where digital options could significantly add value to trial design and execution.
* Identify unique digital capabilities and platforms that can enhance and augment clinical trials to address current challenges; identify necessary "building blocks" (eg. Master Data, Process Framework, People Capabilities) for the organization to be put in place
* Lead cost/benefit analysis assessments for various technology options.
* Identify, select, and partner with external suppliers and contract manufacturers to enhance Roche's digital capabilities in the clinical space; lead projects to bring these capabilities on board.
* Develop framework for effectively identifying trial candidates and matching clinical trials to appropriate technology options.

Job Requirements

* Bachelor's degree with 12+ years of relevant experience in the pharmaceutical, IT or related industry; 10+ years of experience with a Master's degree
* Possess strong analytical skills and strong skills/experience in decision analysis tools and methods
* Experience setting strategic direction within organizations
* Full use and application of Supply Chain/Business Process/cGMP theories, principles, and systems
* Ability to effectively interpret Quality Standards as they relate to various technology options
* Ability to manage projects from initiation to delivery
* Ability to independently set work objectives and priorities without direction; proven ability to succeed when given significant latitude in determining objectives and approaches to assignments.
* Possess a strong understanding of available digital capabilities and platforms within the clinical trial setting
* Ability to communicate clearly and professionally both in writing and verbally
* Significant experience in Clinical Supply Chain and/or Clinical Operations
* Demonstrated project leadership and management skills

Preferences

* Experience in GMP Biopharmaceutical production facility
* Experience managing significant IT implementation projects
* APICS CPIM certification and/or Project Management Professional certification

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