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Business Development/Safety Project Management Associate

Business Development/Safety Project Management Associate. Work within the pharmaceutical industry practices and standards for new drug development and safety reporting. Organize aggregate safety data including adverse events, concomitant medications and lab data. Prepare and lead safety oversight meetings for global phase III trials and study pharmacovigilance team meetings. Assist in responding to safety data inquiries from global regulatory health agencies. Manage and quality control safety data listings from multiple oncology studies for annual regulatory safety reporting and ongoing safety data collection. Provide quality review and ensure compliance of safety documents including safety management plan, cohort management plan, medical management plan, investigational brochure, and any necessary components of new drug marketing applications. Manage relevant budget, invoices, timelines and weekly report to executive management. Liaise with the parent company for valuation assessment and press release. Assist sister companies in review and execution of licensing contracts with potential partnering companies. Support sister companies in drug candidate licensing due diligence and technical business meetings for international partnering companies. Technically review confidential and non-confidential business slides and corporate brochures. Facilitate communication between study team and investigator site, clinical research associate, and vendors of phase I/II oncology clinical trials. Coordinate study team review of study documents. Support study manager in overseeing drug safety activities including individual case safety reporting, aggregate safety data reporting, and reconciliation between safety and clinical databases. Review master list of concomitant medications on drug-drug interactions with investigational study treatment. Requires B.S. degree in the medical professional field (Pharmacy, Nursing) plus 3 years of experience in medical review and drug safety management and advanced knowledge in assessing and mitigating medication risk including drug-drug interactions/pharmacodynamics and safety reporting; knowledge of drug development standards and drug approval process; understanding of business client and fostering good vendor relationships; familiarity with oncology and clinical research regulations, i.e., FDA, GCP, GVP, HIPAA and International guidelines. Job located in South San Francisco, CA. Resume to: LSK BioPartners, Attn: Angie Price, 400 Oyster Point Blvd., Ste. 226, South San Francisco CA 94080.


LSK BioPharma and Jiangsu Hengrui Medicine Announce FDA Clearance to Initiate a Phase 3 Clinical Trial in Advanced Hepatocellular Carcinoma (HCC)


Principal Medical Writer