Senior Director / Director, Program Management (Tarloxotinib)

BACK

Rain Therapeutics is committed to building a passionate team of core business leaders to execute on our vision to identify, and execute on the development, of novel therapeutic avenues for the treatment of cancer.  The personality of Rain will always be focused on entrepreneurs with autonomy to build their respective teams in a flat organizational structure.

Summary:

Responsible for creating and maintaining a corporate roadmap and project plan across all functional groups for the execution of Rain’s objectives for tarloxotinib (Tarlox).  The Sr. Director / Director of Project Management will engage with all groups at the Company and be required to ensure frequent status updates on documented deliverables and tasks to preserve the company-wide action plan for Tarlox. Meticulous attention to detail is a critical quality of the position, along with proficiency with new forms of technology to ensure adequate communication across the Company. This individual will work closely with the project team members representing nonclinical, clinical, regulatory, CMC, quality, legal and finance departments in a matrix team environment to develop concise strategic development proposals, integrated project plans, and manage and track key project deliverables. The Senior Director of Project Management will report directly to the CEO of Rain Therapeutics.

Critical Job Skills:

  • Spearhead the creation of a global project plan and Gantt chart to manage all deliverables for the Tarlox program, including, but not limited to:
    • Regulatory authority discussions and filings
    • Manufacturing
    • Clinical Development
    • Non-clinical research efforts
  • An amenable personality to be demanding of groups on progress updates while successfully managing relationships
  • Strong writing skills and a comprehension of writings as a means to manage relationships through written forms (i.e. emails and other)
  • Manage a network of consultants when needed
  • Technological proficiency and amenability to always search for new technologies that enhance Rain’s ability to gather and present information to interested stakeholders
  • Passion to learn details about all the functional groups within the company
  • Incorporate budgetary considerations in project planning and timeline considerations to develop scenarios for capital utilization
  • Other responsibilities to ensure full execution of the corporate CMC objectives
  • Proactively facilitate and lead team discussions on project strategies, short-term and long-term project planning, opportunities for expediting timelines, identification resource constraints, and proactively identify complex project issues and risks, and assure appropriate escalation
  • Manage Cross-Functional 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/MAA, etc.)
  • Assist finance and functional area leads in the development and maintenance of program budgets aligned with the integrated project plans
  • Assist in the review of regulatory documents, SOPs, protocols and reports, where relevant
  • Work closely with senior management and functional area leads on ongoing enhancements and development of team processes, structures, and project reporting tools

Preferred Education and Experience:

  • PMP certification strongly preferred
  • At least 5 years’ prior experience in project management for a clinical-stage drug development program required
  • Experience and passion to work with small teams
  • Small company, biotechnology experience strongly preferred
  • Managerial experience overseeing third party consultants and vendors in achieving corporate objectives
  • Strong understanding of Drug Development process and US and EU Regulatory requirements
  • 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
  • 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
  • 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.)
  • Presentation skills and poise in speaking in public settings
  • Strong capabilities in creating presentation materials in slide and written formats
  • Demonstrated record of being demanding of groups to meet timelines
  • Demonstrated ability to collaborate successfully with multiple functions in a team environment
  • Strong critical, strategic, and analytical thinking skills