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Biometrics and Clinical Data and Standards Technology Platforms Associate Director

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Wednesday, January 24, 2024

Job Description

General Summary:

As a member of the Data, Technology and Engineering (DTE) Global Medicines Development & Medical Affairs (GMDA) team, the Associate Director - Business Engagement & Technology will be a key resource in ensuring the planning and delivery of key commercial-off-the-shelf (COTS) and a wide range of custom solutions in support of our Biostatistics, Real World Analytics and Statistical Programming business partners. The incumbent will partner with DTE and business leadership to develop capabilities and system roadmaps that align to support business strategy and drive delivery of the technology portfolio across Biometrics and Clinical Data and Standards Platforms, including but not limited to: Metadata Repository (MDR), Clinical Data Workbench, Statistical Computing Environment and other Biometrics platforms
As a potential people manager, the incumbent will successfully manage and coordinate day-to-day responsibilities of the team to ensure their success and career development, in addition to related financial management and human resource responsibilities.

Key Duties and Responsibilities:

  • Become a trusted partner of Biometrics business leaders
  • Manage the lifecycle of Biometrics portfolio solutions - defining business need, project planning, vendor selection, development, deployment, and end user adoption and provide ongoing management and functional oversight for those systems.
  • Business relationship management and ownership of a variety of technology platforms enabling core capabilities related to Vertex Biometrics functions.
  • Digital Strategy - Assists in building an aligned vision for digital Global Biometrics environment. Develops governance structures for digital engagements across multiple channels and functions. Demonstrates appropriate risk management in context of changing business and regulatory environments.
  • Digital Solution Management - Understands the evolving needs of the business, appropriately prioritizes technology demands, and selects appropriate solutions, tools and platforms to be deployed.
  • Navigates a complex digital ecosystem supporting global trials, GMDA partners, and a variety of 3rd party providers to deliver timely, GxP compliant solutions capable of managing the breadth and volume of an expanding therapeutic portfolio.
  • Digital Improvement – Serves as platform owner for Biometrics technology portfolio, ensuring new features and functionality are identified, designed and implemented in alignment with key business areas
  • Translates outputs of operational data analysis to clear insights for management consideration: Works with functional leaders to align on key measures, metrics for success, and clearly communicates business value
  • Stays current with new developments in clinical systems, drug development, and regulatory guidance, including global regulatory standards for data and document solutions
  • Pro-actively identify and mitigate key cross-functional and vendor issues escalating to senior management where appropriate
  • Manages budgetary spend for programs and projects within their remit.
  • Manage a large Managed Service’s Team

Knowledge and Skills:

  • In-depth knowledge in the core disciplines of project management, business analysis, solution design, delivery, and testing
  • Experienced in building productive partnerships with business and technology stakeholders and aligning them around a recommendation/solution
  • Customer focused, with ability to maintain an independent view - Proven ability to interpret internal and external customer needs, negotiate and influence
  • Strong understanding of Biometrics processes
  • Knowledge of Biometrics digital strategy generation ie automation of SDTM and ADaM standards, integration & alignment with multiple constituents, functional area strategies and objectives
  • Experience in the pharmaceutical/biotechnology industry and extensive knowledge of ICH-GCP guidelines, 21 CRF Part 11, and major Health Authority regulations as they pertain to clinical studies
  • Results oriented contributor with a proven track record of on-time project delivery for large, complex projects with global stakeholders
  • Demonstrated ability to analyze complex issues, develop relevant and realistic recommendations and plans, and drive projects to consistently meet multiple deadlines while mitigating risk
  • Exceptional written and verbal communication skills and ability to present complex or sensitive information in a clear and concise manner to audiences at all levels of an organization
  • Strong analytical, quantitative, problem-solving and prioritization skills including development of business case / value propositions
  • Experience running IT managed services or outsourced/offshore teams - Vendor management skills to drive effective governance, inspection readiness, and desired results
  • Very strong MS Office skills, including MS Project & Visio, Excel and PowerPoint experience
  • Excellent interpersonal skills - ability to develop relationships with key stakeholders, maintaining good conflict management and negotiation techniques
  • Experience in Agile development and project management methodologies

Education and Experience:

  • Bachelor's degree in technology discipline, strategy, life sciences, or equivalent (Graduate degree or certifications in related field preferred)
  • Typically requires 9 years relevant business experience in the Life Sciences industry, or the equivalent combination of education and experience
  • Substantial program/project management, demand management, resource management and system lifecycle expertise
  • Experience with Agile development or program management methodologies
  • Proven relationship management capabilities
  • Expertise in SAS and R
  • Knowledge and/or experience with broad array of Biometrics including: Metadata Repository (MDR), automation of SDTM and ADaM Datasets, Clinical Workbench (elluminate), SAS, Enterprise R

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 known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at