Senior Director, Project Management Clinical Development

4 days ago

Alameda, California, United States Exelixis Full time
Job Summary:

The Senior Director, Project Management Clinical Development will partner with project leaders and department leaders to oversee progress of development programs. This role ensures timely communication of project information to cross-functional stakeholders and serves as liaison between project teams and executive management. The Senior Director, Project Management Clinical Development will oversee and manage the operational aspects of ongoing oncology drug development projects (IND-enabling, Phase 1 to 3, NDA/BLA filing submissions).

Key Responsibilities:
  • Responsible for directly managing one or more clinical development projects and overseeing management of projects or project activities by more junior project managers.
  • Leads or contributes to PM and Development department initiatives to establish and implement best practices.
  • May facilitate governance processes, serving as a liaison between project teams and senior/executive management to address issues and ensure appropriate project oversight.
  • Supports and facilitates career development of PM staff. Provides insights and education based on experience. Monitors work product of subordinates and provides guidance.
  • When functioning in the role of a PM, works in partnership with the PTL and project team to develop and gain approval of the project strategy.
  • Facilitates discussion and agreement on clear, concise program goals. Measures and reports progress against agreed milestones. Develops options and recommendations for moving plans forward to maintain milestones and goals.
  • Drives project execution through the development and implementation of high quality, integrated cross-functional project plans.
  • Identifies risks and issues which pose a challenge to achieving strategic goals; develops and implements plans to mitigate risks, resolve issues and execute corrective actions.
  • Ensures that program information is communicated to team members and other project customers. Coordinates communication within the organization as well as with external business partners or consultants.
  • Supports the PTL in representing the project team in governance and to senior management.
  • Ensures uniform processes/documentation between projects.
Requirements:
  • BS/BA degree in related discipline and a minimum of 15 years of related experience; or, MS/MA degree in related discipline and a minimum of 13 years of related experience; or, PhD in related discipline and a minimum of 12 years of related experience; or, Equivalent combination of education and experience.
  • PMP or equivalent certification is preferred.
  • At least 5 years of experience managing cross-functional development-stage projects in the biotech/pharmaceutical industry.
  • Experience managing oncology projects and/or development of biologics is preferred.
Preferred Qualifications:
  • Extensive understanding of the full Drug Development process (oncology is preferred).
  • Must be able to communicate scientific and business elements associated with assigned projects.
  • Self-motivated, comfortable working in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
  • Effective communication, interpersonal, collaboration, and negotiation skills. Demonstrated ability to drive results without formal authority.
  • Highly organized and efficient, close attention to detail and able to orchestrate multiple projects simultaneously.
  • High proficiency with MS Office Suite, MS Project, Smartsheet or equivalent project management software.

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