The responsibility of the Sr. Clinical Scientist is to take a leadership role in overseeing the design, implementation and conduct of clinical trials to insure the quality and integrity of data and safe and proper management of study parameters. In coordination with clinical operations and clinical research team members, exercise a leadership role for project activities related to scientific and medical management functions by interfacing with vendors, clinical investigators and other site personnel in order to carry out this responsibility. Ability to work independently without constant monitoring and to make judgments and decisions within project assignments.
Reviews scientific literature and develops product knowledge in order to effectively understand and communicate information relating to clinical study products and therapeutic areas.
Develops and reviews study protocols and informed consents, generates other related study documents and forms, as needed.
Collaborates with Clinical Operations with the identification of and interaction with potential investigators, prepares and presents clinical, pharmacogenomic and biomarker data at investigator meetings.
Assist Clinical Research and Translational Medicine teams in selection and set-up of pharmacokinetic, pharmacogenomic, and biomarker vendors. Collaborate with Clinical Operations to design contract and work order.
Serves as primary liaison with internal scientific and medical experts to ensure protocol execution is consistent with intent, coordinates and oversees medical or end-point specific training for study protocols, provides scientific oversight of vendors associated with primary endpoints(s) and pharmacokinetic, pharmacogenomic, and biomarker data.
Serves as primary clinical liaison with data management and medical to ensure the CRFs are appropriately designed assists in ongoing data reviews, including of vendor data, and AE/SAE reconciliation, participates in DMC meetings.
Writes and provides scientific/medical input, review and edit of clinical study reports, Investigator Brochures, INDs, NDA, annual reports, integrated medical reports and other regulatory submissions.
Provides Senior Management with regular study updates/status reports on study data, participates and assists with advisory/scientific boards; prepares and presents clinical data at external scientific/board meetings as needed.
• PhD preferred in PhamD, Oncology, Biology, Pharmacology
• 5-10 years of biotech/pharma/CRO experience with at least 4 years in clinical research. Previous experience in Translational Medicine and oncology preferred.
• Good understanding of ICH, GCP and relevant regulatory requirements highly desirable
• Strong medical writing and analytic skills
• Ability to travel globally up to 25%
• Excellent verbal and written communication skills
• Excellent inter-personal skills
• Excellent computer skills, specifically hands-on experience with Word, Power Point and Excel
AVEO Pharmaceuticals (NASDAQ: AVEO) 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.
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