Praxis

People Operations

• Coordinate core People Operations processes, including benefits administration, leave of absence support, and execution of pay related actions all while ensuring accuracy, compliance, and a high standard of execution.
• Support the full workforce lifecycle across both employees and consultants, from onboarding through offboarding, partnering across teams to deliver a smooth, well-run experience.
• Coordinate and support key People programs, including open enrollment, the Social Feedback System, and core employee experience moments such as 90-day check-ins and culture commitments.
• Partner on employee relations–related processes and actions, helping to ensure thoughtful, consistent, and well-documented outcomes.
• Contribute to the planning and execution of company-wide events and gatherings, working closely with the Admin team to create high-quality, well-run experiences.
• Maintain and improve People Team systems, templates, and documentation to support clarity, efficiency, and scale.
• Support compliance and reporting needs, including employment verifications, audits, and data integrity across systems.

People Team Specialist

Operations

• Be the TMF subject matter expert and trusted partner to study teams.
• Oversee eTMF set-up, maintenance, and regular quality reviews.
• Monitor TMF health, milestones, and deliver metrics and insights to teams.
• Guide and support trial teams to stay compliant with document lists and timelines.
• Identify and resolve TMF issues, escalating when needed.
• Contribute to SOPs, processes, and industry best practices.
• Ensure access and compliance with global TMF standards and regulations.

TMF Operations Lead

Compliance

• Ensure continuous, compliant and timely regulatory submissions
• Create and manage submission content plans in conjunction with Regulatory Affairs strategy and CMC leads, cross-functional colleagues, and global vendors, from initiation through to approval and dispatch, for all Regulatory submissions (IND, IMPD, NDA, MAA, Agency Responses, others)
• Publish, validate, and transmit eCTD submissions to the gateway
• Track regulatory commitments for assigned products
• Schedule and coordinate, with contributing departments, the development of submission deliverables
• Communicate directly with functional authors to obtain submission documents in a timely manner
• Manage the publication and submission of regulatory documents in electronic common technical document (eCTD) format, and/or paper submissions, when required
• Oversee the writing, review, implementation, and continuous improvement of standards, templates, and procedures related to the publishing, review, QC, transmittal, and archiving of paper and electronic regulatory documentation
• Develop and maintain best practices, consistent with evolving FDA and international guidelines for electronic submissions
• Serve as a contact for the maintenance of electronic document management systems and publishing tool used to support regulatory submissions, identifying system issues, reaching out to the appropriate resources and stakeholders, and coming up with solutions.

Senior Manager, Regulatory Submissions

Data Scientist

• Lead the design, development, and validation of R/Python code to automate generation of analytical datasets and TLFs.
• Translate SAPs and metadata specifications (YAML/CSV) into executable and reproducible code.
• Build and validate R packages and data science tools supporting both exploratory and confirmatory analyses.
• Implement and validate statistical models (e.g., MMRM, ANCOVA, logistic regression).
• Collaborate with IT to integrate data science workflows within Databricks and CI/CD pipelines.
• Collaborate across programming, biostatistics, and data standards functions.
• Conduct peer code reviews, unit testing, and automated validation.
• Mentor and guide team members in best practices for programming, validation, and automation.

Statistical Data Scientist

Director

• Build the commercial hiring engine from the ground up.
• Further develop and execute the talent strategy to support go-to-market buildout.
• Partner with leadership as a trusted advisor and challenge assumptions.
• Define and operationalize hiring criteria based on company values.
• Upgrade talent assessment methods with simulations and case work.
• Lead and scale the Talent Acquisition function.

People Team Specialist

TMF Operations Lead

Senior Manager, Regulatory Submissions

Statistical Data Scientist

Director, Talent Acquisition