Director/Senior Director, Drug Safety
About Us:
Timberlyne Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for high unmet medical needs. Timberlyne’s lead program is CM313, an IgG1 monoclonal antibody with enhanced complement-dependent cytotoxicity that targets CD38. By targeting CD38, which is highly expressed on plasma cells, NK cells, and other immune cells, CM313 modulates multiple immune cell types leading to both rapid and durable responses across a range of autoimmune diseases and cancers.
Position Summary:
Timberlyne is seeking a Director/Senior Director to lead the Drug Safety function and provide expert support to internal stakeholders including Clinical Operations, Medical and Regulatory Affairs on matters of patient/subject safety. This person will be responsible for overall accountability for the expert output of the Drug Safety function. Successful execution will involve strong analytical and report writing skills to support the safety evaluation, benefit/ risk assessment, signal detection, aggregate safety report generation and responses to regulatory authority enquiries.
Essential Responsibilities :
Skills and Experience:
How To Apply: Please send your resume to careers@timberlyne-tx.com
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity/expression, national origin, disability, medical condition, age, marital status, status as a protected veteran, or any other legally protected characteristic.
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