Portola Pharmaceuticals, Inc. was founded in 2003 and is headquartered in South San Francisco, CA. We completed an initial public offering in May 2013 and are traded on the Nasdaq Stock Market under the symbol PTLA. We have approximately 85 employees. At Portola, our goal is to build an enduring biopharmaceutical company with compounds from our own research efforts that advance the care of patients in the areas of thrombosis (blood clots), other hematologic (blood) disorders and inflammation. Our development-stage portfolio includes three 100 percent-owned clinical-stage assets; betrixaban and andexanet alfa (PRT4445), which address significant unmet medical needs in the areas of thrombosis; and PRT2070, an orally available kinase inhibitor with unique pharmacologic properties that targets hematologic cancers.
The Senior Clinical Trial Manager (CTM)/Associate Director, Clinical Operations will be responsible for the operational management and oversight of clinical trials within a clinical development program; the level of independence and scope of responsibilities assigned may vary depending on the experience of the successful candidate. The CTM/AD will work closely with the Medical Monitor and other cross-functional representatives, including Clinical Data Management, Biostatistics, Regulatory/QA, Pharmacology, Biology, etc. to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget. The CTM/AD will also provide oversight of the CRO and other third party vendors on assigned study. This individual will report into the Director of Clinical Operations. This is an in-house position.
Role Profile: The title for this position will be commensurate with the successful candidate’s experience and anticipated scope of responsibilities.
• Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Director or CRO as appropriate
• Perform clinical data review of data listings and summary tables, including query generation
• Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits
• Develop and maintain good working relationships with investigators and study staff
• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
• Track and report on progress of study including site activation, patient enrollment, monitoring visits
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience)
• Investigate queries, monitor discrepancies
• Manage investigational product (IP) accountability and reconciliation process
• Responsible for review or approval of IP release packages
• Negotiate and manage the budget and payments for investigative sites, if applicable
• Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
• Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
• Assist with CRA and third party vendor training on protocols and practices
• Assist in identification and hiring of appropriate CROs and third party study vendors
• Other duties as assigned
• Experience in managing industry sponsored clinical (pharmaceutical) trials.
• Cross-functional team leadership experience preferred (at least 2 years)
• Management of international clinical studies preferred
• Cardiovascular and/or oncology study experience preferred
• Experience managing vendors, including performance assessments and total financial management (invoice review, change order management, budget reforecasting, etc.)
• Previous experience working with an electronic data capture system and CTMS system required
• Proficient with MS Word, Excel and PowerPoint. Experience with MS Access and MS Project a plus
• Strong interpersonal, communication (written and verbal), and organizational skills
• Demonstrated ability to work independently as well as part of a multi-functional study team
• Able to motivate a team to work effectively under a changing environment
• Able to solve problems under pressure
• Self-motivated and able to work effectively in a matrix/team environment
• Availability for potential travel domestically and internationally
• 6- 8+ years Clinical operations work experience in the pharmaceutical industry and working knowledge of GCP/ICH guidelines and the clinical development process
• Global Phase III experience in cardiovascular or oncology drug development desirable
• Bachelor’s degree or equivalent
• Our company overview and history: http://www.portola.com/Company-Overview
• Please include a cover letter that highlights your qualifications and matches our requirements and send resumes to firstname.lastname@example.org
• Recruiters: Please click this link for more information: http://www.portola.com/Recruiters-and-Vendors.