Project Manager

At Pharmacyclics, our every effort is directed to bringing new therapies to life: treatments that help people return to the lives they love as quickly and easily as possible. We believe there is nothing more powerful than giving back in this way. We believe there is nothing more valuable than turning hope into reality and allowing people to focus on the splendor in every day. This is what we call the magic of normal—and we want this for as many people as possible.

This candidate will be expected to operate independently under the broad guidance of the Associate Director of Project Management. The candidate will be responsible for assisting the Clinical Trial Manager (CTM) and Clinical Development functions in tracking, documenting, and ensuring quality and timely delivery of all clinical trial deliverables. The candidate will be accountable for the implementation and maintenance of cross-functional clinical trial timelines for drug development programs from protocol through clinical study report and for monitoring progress against the plan and against established process metrics. This role ensures alignment of Clinical Development operations with the company’s overall portfolio strategy.

* Manage the development, implementation and monitoring of realistic cross-functional clinical trial timelines for multiple drug development programs * Conduct quality control checks of clinical trial data entered into designated databases to ensure accuracy of clinical trial timeline information and its alignment with the company’s portfolio strategy * Monitor progress against the plan and against established process metrics * Assist Clinical Trial Manager in developing contingency and/or risk mitigation plans to ensure timely delivery on clinical milestones * Ensure effective hand-offs between Clinical Operations and Regulatory Affairs for IND and filing related activities * Be accountable for one or more Project Management internal tracking/reporting systems, * processes and/or templates * Collaborate with Clinical Trial Manager to identify study needs, bottlenecks and provide process improvement solutions to maximize effective clinical trial execution * Act as liaison between the Project Management department and database/IT representatives responsible for maintaining, integrating and/or upgrading designated databases * Facilitate and drive meetings effectively and clearly communicate decisions and action items to team members and relevant parties outside of the team * Compile trial-related information for use with or deliver to internal or external groups * Maintain strong working relationships with Clinical Operations, Clinical Science and Regulatory Affairs * Partner with Clinical Operations to create a team environment that fosters collaboration and ownership * Adhere to all policies, Clinical Development processes, SOPs, and clinical project management processes

* Advanced degree in science is desired (e.g. MS, PhD, MBA) or commensurate experience * 4 or more years multi-disciplinary experience in the biotech/pharmaceutical industry, with involvement in drug development for at least 2 years * Knowledge of overall drug development process relevant to pharmaceutical/biotech organizations * Excellent organization skills, multitasking, and clear communication is needed * Proficiency with project management practices, tools, and methodology (knowledge of MS Project required) * Strong computer literacy, including word processing, presentation, and spreadsheet applications * Strong influencing skills, ability to build consensus with multi-functional teams and strong critical thinking * Strong analytical skills, with an ability to communicate complex issues in a simple way * Demonstrated strategic skills and leadership skills * Proven track record of good decision making and exercising sound judgment * Results and detail-oriented; self-motivated * Working knowledge/understanding of best-practice alliance/collaboration management principles and concepts, techniques and tools * Experience in configurable application software and analytical development methodologies (Excel, Access, Spotfire) a plus * Project Management Professional (PMP) certification a plus