Role Summary

We are looking for an experienced Project Manager reporting into the VP of Clinical Operations. The successful candidate will be responsible for working closely with project team members representing preclinical, clinical, regulatory, operations, CMC, quality, legal departments in a team environment to develop concise strategic timelines, integrated project plans, and manage and track key project deliverables alongside Project/Program Leads. The candidate will provide regular project team deliverables and progress updates to VP of Clinical Operations and at cross functional team meetings.

Role Responsibilities

  • Proactively facilitate and lead team discussions on project/study 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 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/study development timelines (integrated project timelines), 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.) to support clinical studies.
  • Develop, track and maintain project gantt charts, work with teams to identify key areas of improvement and efficiencies.
  • Assists in the review of project team regulatory documents and SOP revisions, if relevant.
  • Work closely VP of Clinical Operations 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.).

EEO & Employment Eligibility

  • Turning Point Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Turning Point Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Turning Point Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com

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