Technology Enablement Director – Intelligent Safety Automation

United States of America, California, South San Francisco
Switzerland, Basel-City, Basel
United Kingdom, Hertfordshire, Welwyn

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For this new, strategic Technology Enablement Director position, we are looking for an experienced business leader who is an expert in cutting-edge intelligent automation technologies, including machine learning and artificial intelligence, and who will be a key contributor to identifying opportunities to include such technologies in our current and future PV systems environment in collaboration with key business and IT stakeholders.

Roche’s Product Development Safety Risk Management (PDS) organization enhances healthcare for patients by elucidating and communicating the safety profile of Roche medicines to optimize their benefit-risk profile. 

The Pharmacovigilance Intelligent Automation and Business Systems Solutions (PVIS) group has overall responsibilities for business-owned safety systems activities, including business responsibilities of the evaluation, implementation and maintenance of technology solutions to enable business processes. It anticipates potential new enabling technologies, partners with industry and regulators, and identifies opportunities to test, deploy and incorporate new solutions into ways of working supporting the product lifecycle. PVIS Business System Owners areaccountable for maintaining the validated state of the PV systems complying with Computer System Validation (CSV) policy and processes. 

PVIS is continuing its transformation towards an open, dynamic, transparent, inclusive, collaborative and agile work environment. PVIS members are committed to deliver faster and bolder innovations, making key contributions to help implement and maintain PV systems in support of the Roche Pharma Vision, embracing the Pharma Operating Principles. They are motivated by purpose and spend their time contributing where it adds the most value. PVIS members work flexibly in a flat hierarchy as part of empowered, self-managed, multi-skilled teams, organized in a “flow-to-work” model. They work collaboratively and share expertise across the organization to remove silos and duplication, and deliver solutions through agile ways of working and an agile mindset.

You are a thought leader and senior business expert, responsible for leading initiatives, programs and/or workstreams relating to the design, development and implementation of computerized systems supporting critical PV and safety activities. As such, you are a key contributor to identify opportunities and co-create a pharmacovigilance systems strategy that pilots and implements efficient cutting-edge technology on new platforms, including intelligent automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies. With the primary aim of exploiting existing and emergent technologies that could be used to improve the effectiveness and efficiency of safety-focused activities and/or enable automation.  

You combine business systems analysis expertise, advanced knowledge of ‘Intelligent Automation’ (IA) technologies (e.g. machine learning, AI, robotic process automation, etc), and knowledge of relevant PV and safety business activities, with an ambition to enhance healthcare through information. 

You develop strategies and plans to promote and facilitate new and improved data flows and information sharing. Your expertise in analytics will be used to shape new technological and information-centric business solutions in the field of pharmaceutical safety. 

You possess subject matter expertise in relation to critical PV and safety activities, in order to anticipate IA-related opportunities for PV and safety innovation or continuous improvement, via systems and technologies. You apply the advanced expertise in intelligent automation with PV expertise to develop strategies or proposals to improve and innovate in assigned areas of systems activity, across business process clusters, in line with PDS and wider business goals.

You act as an expert adviser to assess and apply new machine learning methods to safety domain problems and to the integration of safety-related IA-based solutions with those deployed in the wider Roche organisation. You are capable of developing complex models, along with the technical training and testing approaches for such models, to evaluate suitability and ensure optimal performance.

You anticipate emerging Intelligent Automation technologies from research publications and industry partnerships/developments. You identify opportunities to design, test, deploy and incorporate new solutions into safety-related ways of working, supporting the Roche Safety strategy and wider business strategies (e.g. Pharma Vision). 

You collaborate closely with relevant counterparts across the Roche safety community (e.g. relevant GPOs, safety strategy teams, etc), with PD Informatics (PDIX) partners, and with wider Roche functions, as applicable, to co-create,design, pilot, test and/or implement the above.

You collaborate with the Group Director PVIS, wider Roche Safety Community stakeholders, and PDIX business partners to define and maintain a strategic PV systems roadmap that appropriately reflects the known and potential future opportunities to apply IA technologies across the safety arena: Considering wider industry trends, emerging technologies and other innovation opportunities.

You influence wider business and IT stakeholders, including at senior leadership levels, to drive cross-functional improvement and innovation of safety systems and technologies that support safety-focused business activities. You focus on sustaining an active and collaborative network externally, including collaborations with peer companies, industry organizations, system vendors and health authorities. You will typically represent Roche at relevant conferences and are likely to co-author relevant publications in your field.

You act as a coach and expert adviser to Business System Owners and members of the PV Business Systems Solutions Director/Analyst job family across all PVIS business areas, and provide guidance on intelligent automation technologies and their application.

Overall you play a key business-focused technology enablement leadership role and act as a key contributor for Roche strategic initiatives, programs and projects relating to safety activities and their automation. You will typically represent PDS in relevant Pharma and Roche-wide working groups relating to IA and you will be, or have the clear potential to become, a recognised safety industry leader in Intelligent Automation and Machine Learning. 

Your Primary Responsibilities are

  • Developing continuous improvement and innovation strategies or proposals for the safety systems landscape in the area of intelligent automation, in line with Roche Safety strategic focus areas, as well as PD, Pharma and corporate goals and ambitions

  • Ensuring that efficient cutting-edge technologies and platforms, like intelligent automation solutions utilizing artificial intelligence (AI) and machine learning (ML) technologies are incorporated and maintained in collaboration with PDIX

  • Establishing and maintaining strong relationships with key stakeholders internally and externally, to share new ideas and to anticipate changing customer requirements

  • Maintaining advanced subject matter expertise by staying current with intelligent innovation technologies that are or can be applied across the Roche safety systems environment, to enhance PV business process execution and create efficiencies

  • In collaboration with key stakeholders, defining a Data Strategy and leading Safety Data Repurposing initiatives, with the objective of deriving value from investing in safety data assets and utilising them beyond their primary use, e.g. to help solve business and scientific questions on design of clinical trials, personalised safety and reverse translation

  • Keeping up to date on vendor solutions that include intelligent innovation approaches that are commercially available or in development 

  • Initiating and evaluating POCs and pilots based on the above for possible fit in the PV systems environment

  • Leading projects or workstreams to innovate and/or enhance PV systems in line with agreed systems roadmap and business goals

  • Mentoring PV Business Systems Solutions Directors/Analysts and Business System Owners to strengthen leadership capabilities, systems related competencies and skills, and team effectiveness

  • Working closely with the PVIS Group Director, relevant Global Process Owners, Business System Owners and PDIX Business Partners, apply intelligent automation expertise to define and co-create the safety compliance-critical aspects of overall system roadmap

  • Collaborating with wider PDS experts, other PD functions and PDIX to assess, align, co-create and implement such technologies in line with functional roadmaps. 

  • Additionally, you may represent PDS on relevant Roche or Pharma-wide forums that focus upon IA-related solutions

  • Embracing and promoting agile mindset and agile way of working, and adjusting quickly to an environment with changing priorities, technologies and regulatory framework

  • Promoting a culture of continuous innovation and a solution-orientated mind-set in order to enhance and evolve safety-related systems and automation solutions

  • Providing relevant SME input to the communication, training, implementation, follow-up and feedback, relating to IA-related safety solutions

The above statements are intended to describe the general nature and level of work being performed by you. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required.

Education, Skills and Experience

  • Degree in data sciences, computer sciences or similar field, graduate or higher-level degree preferred

  • Experience in the field of pharmacovigilance or product development preferred

  • Prior experience of the application of intelligent automation technologies in a relevant business setting is essential. Typically, with 10+ years of relevant experience of  managing and improving business systems in a problem-solving capacity, with typically 5+ years specifically involving the application of machine learning, AI and/or other emergent technologies.

  • Experience in network or line leadership roles: Leading global teams to deliver complex, cross-functional technology-enabled business projects of high business importance/risk in an international and multicultural organization

  • Extensive experience in the practical application of intelligent automation technologies, ideally in a safety-related environment and/or with broad awareness of relevant PV activities

  • In-depth understanding of key regulatory requirements, any associated external guidances, and their implications with respect to the design, validation, implementation, maintenance of or use of intelligent automation technologies in safety-related business settings. Typically, with emergent technologies, formal requirements and guidances may lag behind the practical application of technologies and therefore you will typically possess the ability to influence the creation of wider guidances and good practices, with internally or externally.

  • Highly developed communication, presentation and influencing skills, with the proven ability to establish effective collaborations across business units and to influence decisions without authority

  • Advanced strategic and analytical thinking skills, with the ability to rapidly assimilate complex information to inform decisions, and/or make effective business proposals in situations of ambiguity

  • Extensive expertise in the development of efficient software solutions to address complex business problems in a regulated and validated environment

  • Knowledge of database technologies, reporting and advanced analytics tools, industry standard safety systems and medical terminologies, e.g. MedDRA

Travel Requirements

International business travel up to 10% of the time may be required, depending upon the business location of the jobholder and ongoing business project activities.