Sr. Director, Clinical Science - Immuno-Oncology - South San Francisco
Job Summary Senior Director, Clinical Sciences- An exciting role in immune-oncology has become available. This role reports to the VP of Clinical Development. The position is accountable for medical monitoring, patient safety and provision of medical guidance during the design, execution, and reporting of clinical studies and registration with health authorities.
Job Overview COMPANY BACKGROUND:
Founded in 2001, this established, midsize company gives you the chance to be apart of a smaller more dynamic team. They are focused on researching and developing innovative therapeutics to improve the lives of patients with serious diseases. They have entered into strategic collaborations with leading global pharmaceutical companies. This company values an open, productive, and collaborative culture.
• Lead the formulation of clinical development plans, including selection of the proof of concept indications for specific projects.
• Ensure the medical and scientific quality of clinical trial protocols, case report forms, data and data listings, and clinical trial reports.
• Be accountable for safety across relevant studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues.
• Participate in the development and delivery of protocol training for investigator site
• In conjunction with the CMO and Research group, prepare strategy presentations, present and discuss data at relevant team, governance, executive committee, external consultant, OL, and regulatory meetings.
• Contribute to the overall strategy and preparation of documents to secure approval of drugs, e.g., BLAs/NDAs/MAAs.
• Lead or assist in preparation of manuscripts, abstracts and meeting presentations.
• In conjunction with Clinical Science and Operations, be responsible for the on-time and within-budget execution of protocols.
• Other projects as needed
Skills Required • Requires MD with a minimum of 3-5 years of demonstrated knowledge and experience in clinical research, preferably in an industry setting.
• Strong basic science knowledge to enable proof-of-concept and PD biomarker design and interpretation.
• Oncology fellowship training and active board certification within the last 5 years.
• Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
• Able to engage in work-related travel approximately 20%
Contact Details These positions will be snapped up, looking for individuals who are ambitious, positive and want to work in a growing and exciting team for 2018.
Do not miss out on this opening – apply below or contact Corrina at Meet on 628 229 9032 or email directly to email@example.com
You can find out more about Corrina & Meet at www.peoplewithchemistry.com
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