AVEO Pharmaceuticals integrates a proprietary cancer biology platform with drug development and commercial expertise in its efforts to discover and develop targeted cancer therapeutics. The company’s lead product, tivozanib, is an oral, triple VEGF receptor inhibitor with a highly differentiated profile. Tivozanib is currently being investigated in a global, randomized Phase 3 clinical trial called TIVO-1 comparing tivozanib to sorafenib in advanced kidney cancer, as well as additional clinical studies in other solid tumor types. AVEO’s proprietary, integrated cancer biology platform offers the company a unique advantage in oncology drug development and has provided a discovery engine for high-value targets. This approach has resulted in a promising pipeline of monoclonal antibodies against novel targets including HGF, ErbB3, RON, Notch and FGFR.
Post: Senior Clinical Research Scientist, Oncology
Job Description:
• Clinical Research. Review scientific literature and develop product knowledge in order to effectively understand and communicate information relating to clinical study products and therapeutic areas.
• Protocols. Develop and review study protocols and informed consents. Generate other related study documents and forms, as needed.
• Site Selection: Collaborate with Clinical Operations on identifying and interacting with potential investigators.
• Investigator Meeting: Prepare and present clinical, pharmacogenomic, and biomarker data at investigator meetings.
• Vendor Selection: Assist Clinical Research and Translational Medicine teams in selection and set-up of pharmacokinetic, pharmacogenomic, and biomarker vendors. Collaborate with Clinical Operations to design contracts and work orders.
• Study Management: Serve as primary liaison with internal scientific and medical experts to ensure protocol execution is consistent with intent. Coordinate and oversee medical or end-point specific training for study protocols. Provide scientific oversight of vendors associated with primary endpoints(s) and pharmacokinetic, pharmacogenomic, and biomarker data. Oversee tracking of patient samples and timing of sample analyses.
• Data Management & Review: Serve as primary clinical liaison with data management and medical directors to ensure the CRFs are appropriately designed. Participate in on-going data reviews, including of vendor data and AE/SAE reconciliation. Participate in DMC meetings.
• Writing & Presentations. Assist in writing and providing scientific/medical input, review, and edits of clinical study reports, Investigator Brochures, INDs, NDA, annual reports, integrated medical reports, and other regulatory submissions. Participate in and assist with advisory/scientific boards. Prepare and present clinical data at external scientific/board meetings as needed.
• Provides Senior Management with regular study updates/status reports on study data
• Perform other tasks as assigned by supervisor.
Candidate Profile:
• BS degree. Background in life sciences required; advance degree preferred.
• 5-10 years of biotech/pharma/CRO experience with at least 4 years in clinical research. Previous experience in oncology preferred.
• Good understanding of ICH, GCP, and relevant regulatory requirements highly desirable.
• Strong clinical protocol writing and analytic skills.
• Experience with interacting with clinical investigators and medical experts.
• Experience with designing studies incorporating biomarkers is a plus.
• Strong attention to detail and time management skills.
• Ability to multi-task, ability to work independently, exercise sound judgment, and escalate issues when necessary.
• Excellent verbal, written, and interpersonal communication skills (fluency in written and spoken English is a must).
• MS Office
• Ability to travel globally up to 25%.
End Date: March 08, 2011
Other Information:
Experience: 5-10 years
Education: B.S
Location: Cambridge
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Please forward resumes to Careers@aveopharma.com
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