Manager, Regulatory Projects
Pharmacyclics, Inc. - Sunnyvale, CA

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We are seeking a Project Manager who will manage regulatory projects in clinical development. This position will be accountable for guiding the teams through regulatory review process.

Key Accountabilities/Core Job Responsibilities:
  • Partner with Regulatory Leader to manage the development and execution of regulatory timelines aligned with corporate goals.
  • Establish and maintain functionally integrated project schedules to enable accurate project and ensure accurate inputs are provided into business planning processes; Ensures alignment with project sub-teams and functional partners.
  • Ensure regulatory project team activities and decisions are clearly communicated, documented and archived, act as a primary contact for regulatory project team related information.
  • Identifies, recommends, and manages the implementation of process and other improvements; whether pertinent to departmental and/or corporate.
Qualifications/Experience/Education Requirements:
  • Advanced degree in science is desired (e.g. MS, PhD, MBA) or commensurate experience
  • 6 or more years multi-disciplinary experience in the biotech/pharmaceutical industry, with involvement in drug development for at least 2 years
  • Excellent organization skills, multitasking, and clear communication is needed
  • Proficiency with project management practices, tools, and methodology.
  • Knowledge of overall drug development process relevant to pharmaceutical/biotech organizations.
  • Financial acumen; capable of planning and oversight of project budgets and product valuations and an understanding of portfolio management concepts.
  • Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills.
  • Strong analytical skills, with an ability to communicate complex issues in a simple way.
  • Demonstrate ability to translate strategy into action; Strong influence, negotiation, and presentation skills.
  • Proven track record of good decision making and exercising sound judgment.
  • Results and detail-oriented; self-motivated.
  • Proven experience using Project Management software to manage complex project timelines and resources.
  • Working knowledge/understanding of best-practice alliance/collaboration management principles and concepts, techniques and tools.
  • Successful experience in managing direct reports a plus.