We are looking for an experienced Director or Senior Director for our Project Management Team. The successful candidate will be responsible for managing multiple highly complex development projects; co-lead early stage development team(s) to drive preclinical assets into the clinic. Work closely with the project team members representing preclinical, clinical, regulatory, and operations, CMC, quality, legal departments in a team environment to develop concise strategic development proposals, integrated project plans, and manage and track key project deliverables. Provide regular project team deliverables and progress updates to Senior Management.
Proactively facilitate and lead team discussions on project strategies, short-term and long-term project planning, opportunities for expediting timelines, identification of resource constraints, and proactively identify complex project issues and risks, and assure appropriate escalation.
Manage Project Team meetings and facilitate discussions using meeting management best practices to drive project strategy, scenario planning, cross-functional communication, timely and effective decision-making, and successful execution of program objectives. Develop agendas and summarize key meeting discussions and decisions (meeting minutes).
Develop, track and maintain project development timelines (integrated project plans), project deliverables and milestones; including understanding and communicating inter-dependencies and critical path activities.
Work closely with and build strong working relationships with cross-functional team members to develop a collaborative team environment and manage timelines for regulatory submissions (IND/NDA/BLA/MAA, etc.).
Develop, track and maintain project publication plans, work with teams to identify key conferences and journals, coordinate publication development and publication gap analysis.
Assists in the review of project team regulatory documents and SOP revisions, if relevant.
Work closely Senior Management in ongoing enhancements and development of team processes, structures, and project reporting tools.
QUALIFICATIONS
BS in a scientific field required; Master’s degree preferred.
Strong understanding of Drug Development process and US and EU Regulatory requirements.
Minimum of 8+ years of project management experience in drug development
Exposure to early-stage programs (pre-clinical through Phase I/II proof-of-concept) essential; and exposure to late-stage programs (Phase II/III pivotal) a plus.
Able to work independently and creatively with minimal oversight
Proven ability to analyze complex activities and information to help guide decision-making that meets the overall objectives and long-range plans of projects and the organization
Strong ability to proactively predict issues and solve problems, identify risks.
Strong ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team.
Proven ability to balance the strategic needs of the program with tactical day-to-day activities.
Excellent people (soft) skills, conflict resolution, diplomacy and positive influencing abilities.
Outstanding communication, planning and organizational skills.
Highly collaborative team player who fosters open communication and able to facilitate urgent needs.
Successful track record of creating and managing accurate integrated project plans/timelines and the use of project software (Microsoft Project, Visio, PowerPoint and Excel, etc.).
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