Biometric Project Manager

Date: Sep 18, 2023

Location: US

Company: Cytel Software Corporation

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development. In this role you will join our FSP department and will work for our clients, a growing biotech.


As an Associate Director, Biometric Project Management, you will be Instrumental in the strategic planning, leadership and execution of clinical filing plans and other development plans for assigned Operational projects.


You will contribute by:

  • Effectively communicates project expectations and filing status to team members and stakeholders in a timely and clear fashion.
  • Proactively identifies potential elements of risk, devises contingency plans and escalates issues as needed (continuous risk assessment).
  • Leads departmental meetings and cross-functional clinical filing program/project meetings. Coordinates the efforts of team members to deliver projects according to plan.
  • Ensures smooth and timely transition of clinical deliverables to Regulatory. 
  • Works with teams to establish and maintain individual filing document timelines. 
  • Captures project efficiencies/inefficiencies, provides continuous improvement process suggestions to optimize effectiveness and shares these with other teams/programs. 
  • Develops and maintains infrastructure for best practice filing execution framework (processes, tools, templates, best practices) for submission planning and execution.
  • Supports senior management to ensure adequate resources are allocated to meet the study and filing milestones across clinical programs.
  • Provides guidance and support for assigned staff and clinical filing team members.
  • Conducts project post-mortems and creates a recommendations report in order to identify successful and unsuccessful project elements.


What we’re looking for:

  • Minimum 10 years’ industry experience (Pharmaceutical, Biotech, CRO).
  • Skilled project manager with demonstrated ability to lead, manage, and effectively progress an interdisciplinary team.
  • In-depth knowledge and understanding of the clinical development process, specifically the DSS functions.
  • Ability to multitask in a fast-paced environment.
  • Strong interpersonal, communication, diplomacy, negotiation, and presentation skills.
  • Can conform to shifting priorities, demands, and timelines through analytical and problem-solving capabilities.
  • Strong customer service skills.
  • Highly effective communicator across all levels of the organization.
  • Able to present project plan both as big picture view and detailed view; able to look ahead how issues may impact downstream processes and suggest/create mitigation plans/solutions.



What’s in it for you:

  • You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
  • You will be part of an exciting new chapter in Cytel’s history with high growth and opportunities to progress in Senior and Leadership positions within the company
  • Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
  • Work with and leverage the best and brightest minds in the industry