Senior Manager / Associate Director, Project Management


Position Description

Modis is seeking an experienced Project Manager. This individual will help plan, track and report activities within inter-disciplinary functions for various work streams. This role must work cross-functionally as needed to identify and follow-up on deliverables to ensure that team members are meeting milestones. Interacts with nonclinical, CMC, clinical, and regulatory departments and with external stakeholders. This position reports directly to the VP, Program Management.

Key Responsibilities:

  • Work closely with the VP, Program Management to assist in management of development program(s) including planning, execution, and reporting on projects and milestones.
  • Oversee and manage the effective coordination and facilitation of cross-functional team meetings from a program management perspective. Ensure team meetings have prepared agendas, allot adequate time for presenters to prepare, and complete timely composition and issuance of meeting summaries/minutes.
  • Develop and manage global, integrated cross-functional plans for key projects (e.g. indication) for the program by:
    • Identifying key deliverables for each function
    • Understanding and outlining inter-dependencies
    • Ensuring cross-functional alignment and accountability
    • Monitoring progress and adherence to timelines
    • Identifying project issues and facilitating resolution
    • Conducting risk management and scenario planning; drive development of contingency and/or risk mitigation plans
    • Identifying and managing resource gaps
  • Work with Chief Medical Officer and Head of Nonclinical to create, organize and maintain plans and timelines needed to achieve the defined objectives of projects, across clinical and nonclinical projects.
  • Proactively identify constraints, risks, and conflicts that could impact the project schedule and work with team members and management to develop appropriate solutions.
  • Ensure the timely and adequate follow-up on action items, identification of project issues and resolutions.
  • Coordinate activities with external business partners, where applicable; contribute to achieving partnership contract deliverables.
  • Contribute to team effectiveness; facilitate resolution of team dynamic issues.

Job Qualifications:

  • Bachelor’s degree in life sciences or business and 6+ years in Biotechnology, Pharmaceutical, or other Healthcare related field
  • Three (3) years of experience in a drug development Project Management role either supporting a Development function (e.g. Clinical Operations or Regulatory Affairs) or Commercial operations or supporting Project Subteams within a drug development program
  • Drug Development knowledge with basic to strong understanding of other functions relevant to the position which may include: Research, Pre-Clinical, Clinical, Manufacturing & Operations, Commercial, and Regulatory
  • Distinguishes proper balance between strategic and tactical thinking
  • Strong interpersonal skills, negotiation skills, active listening, and relationship management skills
  • Good skill in interfacing effectively with all levels, including senior management
  • Ability to influence others while fostering a value-based environment of high performance and fairness
  • Self-motivated, comfortable in fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Strong verbal and written communication skills; ability to clearly and effectively present information
  • Demonstrates creativity and foresight in anticipating and solving complex project issues
  • Goal oriented and results driven
  • Experience with NDA/MAA filings highly desirable