At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.


Essential Functions:

In this leadership role, you will be responsible for directing DICE Clinical Informatics & Analytics efforts, including data governance and data ontology, ensuring consistency across the organization to enable accelerated drug development and accurate regulatory filings. You will actively collaborate with key stakeholders to understand business operational requirements and priorities, establishing the Clinical Informatics & Analytics vision/roadmap and driving the implementation of technology strategies. You will be responsible to assure adherence to GxP in conduct of DICE trials, with your primary objectives being the quality and integrity of generated data, and the rights and welfare of participants /patients. Proven leadership and the ability to work in a fast-paced environment are essential for this position. This position reports to the Senior Director, Clinical Operations, but will lead initiatives in support of stakeholders across Development.


Key Responsibilities:

Clinical Informatics

  • Develops and executes an adaptive, first-class digital and analytics strategy to support accelerated drug development
  • Leads data ontology working group, develops a framework for a data ontology policy, and oversees deployment of policy documents and builds out of ontology capabilities across informatics systems
  • Evolves our computing, data management and architecture roadmap as the business scales including gap assessment, risk mitigation, and prioritization of projects and investments
  • Educates the company in data literacy and encourages efforts to collect, manage, and use internal and external data to drive operational efficiency and better decision-making
  • Builds and leads a Clinical Informatics team to implement high-quality solutions, ensuring stakeholder groups across Development have access to data and analytics they need to achieve scientific and clinical outcomes
  • Defines clear responsibilities and lines of communication between Clinical Informatics and IT teams; partners with the corporate IT team, ensuring smooth connections with corporate infrastructure, consistent policies and good security practices
  • Authors requirement documents, validation plans, UAT plans and SOPs, as needed.
  • Guides Clinical Informatics strategies across Development, including but not limited to:
    • cloud infrastructure and document control,
    • LIMS/similar systems,
    • Connectivity of clinical data to GXP systems, culture that balances best practices for establishing systems and timely delivery of results in support of company objectives

Vendor Management:

  • Accountable for defining, selecting, implementing and directing external informatics partner and vendor strategies including:
         • Developing and maintaining intelligence on potential informatics partners, including clinical and non-clinical providers (e.g., QMS, CTMS, IRT, Supply Chain, ePRO, TMF, EDC, etc.) and others as required
         • Directing and advising Vendor Management in the evaluation (RFI/RFP process), selection (including assessment of proposal responses, budget analysis, etc) and performance of Clinical Informatics external partners to ensure compliance with DICE corporate strategy and in accordance with scope of work
         • Compiling and maintaining, in collaboration with Vendor Management, regular portfolio-level informatics vendor status reports, to include relationship progress and risks for presentation of routine updates to study teams and Clinical Operations leadership
  • Leads budget oversight activities related to informatics strategy; identifies opportunities to reduce costs, increase efficiency, and mitigate risk related to outsourced informatics services across the portfolio; and assists leadership with outside spend, budget planning and management of actual spend (invoices, PO) for informatics

Quality Assurance (CQA):

  • Partners with CQA to ensure informatics processes are efficient and compliant with ICH GCP E6, and oversees informatics risk mitigation per ICH GCP E6 guidelines Liaises with CQA to establish mechanisms for external partner quality /risk management oversight and improvement related to informatics activities; tracks and monitors vendor deviations
  • Fully understands the need for and importance of being inspection ready and diligently follows all DICE SOPs; identifies and communicates if there are gaps, contributes to new SOPs


Additional Responsibilities:

  • Hires and develops junior colleagues to build a first-class DICE Clinical Informatics team
  • Leads and/or participates in departmental meetings and/or initiatives to enhance the efficiency and effectiveness of the company
  • Builds best practices in operational methodologies, systems and processes, and knowledge management with particular emphasis on quality, time standards and expectations
  • Completes other responsibilities as assigned and agreed upon with direct manager


Preferred Experience and Education:

  • Bachelor’s degree in scientific field, or equivalent training and experience
  • Minimum of 12 years of experience in biotech/pharma/clinical research industry
  • At least 10 years of combined direct experience in informatics, clinical operations, business operations and/ or outsourcing role (Sponsor experience required)
  • Minimum 8 years direct oversight of clinical and/or non-clinical systems
  • Early Development experience required. Start-up experience a plus
  • In-depth understanding of the drug development process and the cross-functional responsibilities including pre-clinical, clinical trial design, study start-up and execution, site management, safety reporting, data management, and biometrics
  • In-depth experience soliciting and critically evaluating service provider proposals, negotiating contractual terms, and growing and fostering healthy vendor /site relationships
  • Extensive knowledge of Good Clinical Practices (FDA and ICH), a solid understanding of 21 CFR Part 11, 50, 54, 56, & 312 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, eTMF requirements and ICH E-6(R1 & R2)
  • Proven ability to manage multiple projects while maintaining quality is required
  • Proactive, energetic, self-assured professional with high personal integrity
  • Demonstrated success in analyzing, interpreting and solving complex issues
  • Ability to think strategically and objectively and with creativity and innovation
  • Strong attention to detail and excellent communication and organizational skills
  • Treats people with respect; inspires the trust of others; works with integrity and ethics
  • Is a true team player; gives and welcomes feedback; contributes to building a positive team spirit; supports other's efforts to succeed; contributes to a positive team spirit
  • Exceptional computer /presentations skills are required
  • Position is based in South San Francisco, with potential for flexible work arrangements


DISCLAIMER

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned.

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