Senior Manager / Associate Director, Project Management
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.
- 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.
- 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