Clinical Supply Logistics Manager
- Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease.
- We are seeking a motivated Clinical Supply Logistics Manager to join our fast paced and growing Clinical team. This position will be responsible for managing all aspects of clinical trial supplies and clinical sample logistics of multiple simultaneous oncology clinical studies. The candidate works closely with cross function teams including Clinical Ops, CMC, Bioassays, QA, Accounting, and other relevant stakeholders for clinical trial materials (CTM) supply forecast and inventory tracking, resupply planning and timelines. He or she is accountable for vendor selection and budget negotiation, importation and exportation permit for international shipments, distribution to domestic and international depots, central labs and clinical sites, inventory tracking and reconciliation, logistics of clinical PK sample inventory, shipment and testing to ensure timely data analysis and documentation, etc. Other activities include project documentation, communicating project performance, and support clinical trials in various areas.
Job Requirements and Qualifications:
- BS or MS in a biological science field, or equivalent experience
- 10+ years of relevant experience in the biopharmaceutical industry.
- Prior experience managing global clinical trial supplies, depots and clinical central labs
- Ability to handle complex projects in the clinical development of all stages while managing priorities and ensuring regulatory compliance.
- Excellent oral/written communication and organizational skills, attention to details.
- Excellent organization skills, dedication and accountable, strong time management, self-starter with attention to details.
- Working knowledge of Coordinate cross functional CMC manufacturing activities to ensure timely and cost effective CTM resupply.
- Must be able to review clinical study tables and listings to ensure clinical data integrity.
- Regulatory inspection support experience preferred.