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Clinical Scientist

Portola Pharmaceuticals, Inc.

Location:
South San Francisco, CA
Posted Date:
8/18/2014
Position Type:
Full time
Job Code:
Clinical Scientist
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Cardiovascular, Clinical Operations, Clinical Research, Clinical Scientist, Medical Writing, Oncology, Scientist Oncology,

Job Description

Portola Pharmaceuticals Inc., is a biopharmaceutical company focused on the discovery and development of the novel therapeutics for the treatment and prevention of severe cardiovascular diseases. With one of the most experienced discovery and development teams in the areas of vascular thrombosis and inflammation, Portola is applying an integrated discovery and development approach to a comprehensive understanding of platelet physiology and vascular thrombosis, with an eye toward developing new therapeutics where current antithrombotic therapies are inadequate.

Portola seeks a Clinical Specialist (CS) with clinical and drug development experience (preferably in hematology/oncology or cardiology, but other fields may be considered) to support Clinical Development deliverables for clinical trials and programs associated with the andexanet alfa program. This program spans Phase II to Phase III, and may involve collaborations with other Clinical Development teams, corporate development partners, and external scientific/academic/clinical organizations. The optimal candidate will proactively participate within a multi-disciplinary team of internal clinical and commercial colleagues and routinely interface with external experts and investigators.

Role Responsibilities
•   Scientific writing:
o   Draft Clinical Protocols and Investigator Brochures, and coordinate the successful completion of documents
o   Conduct literature searches, draft abstracts, safety narratives, and background sections of clinical documents, and ensure that standardized disease/molecule protocol language is incorporated (e.g., eligibility, dose-modification criteria, risk language, key scientific statements)
o   Track items for inclusion in protocols and ICF amendments and ensure the completion of the protocol and any subsequent amendments
•   Serve as a Clinical Science representative on cross-functional teams as assigned
•   Develop study-specific listings with data management representatives and conduct frequent clinical data listing reviews
•   Working closely with the medical monitor, serve as primary point of contact, and triage, for clinical study inquiries from site staff, CROs and site monitors regarding the study protocol, modifications to informed consent, and patient-specific questions
•   Partner with Data Management for CRF design, instructions for unique CRFs, and data quality plan
•   In conjunction with a Medical Director, create and or review clinical slides for internal and external meetings (i.e. Investigator meetings, PSSV and SIVs, Study Coordinator and CRA training, Advisory Boards, scientific meetings). Develop and QC data tables with biostatisticians to support these activities
•   Participate in tracking/analysis of any potential safety events within a given trial and across trials for assigned program(s)
•   In conjunction with Biostatistics and Medical Director, review appropriate analysis and reporting documents (i.e. clinical study report, analysis plan, etc.)
•   As assigned, participate in development of the long-range strategic plans for the assigned program(s)

Requirements

•   An advanced clinical/science degree (e.g., PharmD, PhD, MSN, MPH, etc.)
•   6 or more years of industry/related experience
•   4 or more years of clinical trial experience in industry
•   Knowledge of clinical research across Phase II-III drug development projects
•   Experience working on cross-functional teams
•   Experience authoring clinical trial protocols (Ph II or III)
•   Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance
•   Comprehensive understanding of product and safety profiles
•   Well-versed in medical aspects of GCP, ICH, FDA, EMEA, NICE and other relevant guidelines
•   Experience publishing clinical trial results in referenced journals preferred

Contact Us:
•   Our company overview and history:  http://www.portola.com/Company-Overview
•   This position requires candidates to present a scientific seminar during the interview process
•   Please include a cover letter that highlights your qualifications and matches our requirements and send resumes to careers@portola.com
•   Recruiters:  Please click this link for more information:  http://www.portola.com/Recruiters-and-Vendors  

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