Program Coordinator

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.

Within the Global Medical Sciences group, tracks investigator-sponsored trials (IST) submitted for review. Includes working closely with vendor supporting the online submission portal and external business colleagues as well as external investigators including opinion leaders. Facilitates the on-line activities associated with IST concept submissions, and the internal evaluation, reviews and approval/rejection process through the on-line application portal. Develops a basic understanding of the disease, molecule, and indication. Manages IST studies from proposal to study completion and documents study related information in online database.

* Responsible for reviewing online submissions of concepts for completeness; communicating needs for additional information to complete the submission process. * Work closely with Medical Science Liaisons (MSLs), principal investigators and staff to ensure submission of all Investigator Initiated Study (IIS) related study documentation [Proposal, budget, protocol, Informed Consent Form (ICF), etc.] * Independently coordinates and manages review of draft protocols, final protocols, amendments, ICFs, and investigator IND submissions * Interacts with investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues * Responsible for sending IND Safety Reports on an as needed basis * Initiates drug shipments and ensures that drug supplies are adequate for assigned studies * Develops basic knowledge of the study contract, budget, and payment process including legal language and document structure as it impacts assigned studies * Responsible for initiating and tracking site milestone payments * Communicates status of trial to manager and team * Partners with team members and other functional areas within Pharmacyclics such as Regulatory, Drug Safety, Legal, Clinical Sciences, Biometrics, and Research * Oversees clinical trial study progression, including enrollment updates, invoice payments, and receipt of publications using the IST system database * Contributes to the IST program financial management and provides projections for individual study milestone payments * Independently manages interactions with external vendors * Coordinate the review of submitted CTEP concepts as they are received * Manage the agenda and provide approved minutes for review meetings and presentations, as required * Partner with other internal and partner groups to achieve deliverables * Identify and escalate site, vendor and study related issues, as appropriate * Represent Medical Affairs externally to investigators and internally to Sr Management and partners * Establish and manage project timelines * Perform other duties as assigned

* Demonstrated experience in managing multiple projects * Working knowledge of GCP and FDA regulations * Experience in oncology preferred * Ability to exercise independent judgment within generally defined practices and policies that lead to processes for achieving results * Excellent organization and planning skills * Scientific acumen * Strong interpersonal skills and communication skills (both written and oral) * Ability to problem solve and delegate appropriate tasks to collaborators and follow-up as needed to meet deadlines * Self-motivated, adaptable to a dynamic environment * Able to collaborate effectively with cross-functional team members, and external partners * Proficiency in MS Outlook, Word, Excel and PowerPoint, database management **Experience:** * 2+ years program manager/coordinator experience * Experience in clinical research at either a hospital or pharmaceutical/biotech * Experience in project management a plus