Director / Sr. Director, Clinical Supply Chain
Head of CMC
|Erasca is a San Diego based biotechnology company focused on discovering and developing precision medicines for the benefit of patients with cancer. We are advancing multiple programs targeting biological drivers of cancer and are pursuing additional pipeline expansion opportunities through academic and biopharmaceutical collaborations. Our programs, currently focused on innovative discovery research, take novel approaches to shutting down certain oncogene drivers of solid tumor malignancies. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.
Reporting to the head of CMC, the head of Clinical Supply Chain will be responsible for coordination of investigational medicinal product (IMP) and ancillary supply planning, forecasting, labeling, packaging, distribution, inventory monitoring, and reconciliation for Erasca clinical development programs.
|Essential Duties & Responsibilities:|
|· Collaborate cross-functionally with Clinical, Manufacturing, Regulatory Affairs, and Quality Assurance to manage IMP supply planning including labeling and packaging, utilization forecasting, inventory control for Phase 1-3 international clinical studies
· Strong knowledge in managing external drug depot and organizing international shipment
· Develop clinical supplies distribution plans based on program and study timelines, trial design, recruitment, geography, and manufacturing schedules
· Coordinate drug supply delivery timelines with Clinical and CMC
· Organize Packaging, Labeling, and Distribution to clinical sites
· Coordinate and manage clinical supplies forecasting and utilization to ensure on-time and reliable availability of IMP and required ancillary supplies in support of clinical studies
· Assist in IRT design and development
· Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.
|Required Education and Experience:|
|· Undergraduate degree in a relevant discipline
· 5-10 years of experience in supply chain management function including experience in logistics management of supplies for clinical studies
· Thorough understanding of GMP, GCP, and ICH standards governing IMP labeling, packaging, and distribution
· Ability to co-ordinate efforts with CRO/CMO partners and internal multi-disciplinary teams
· Experience in oncology clinical trials highly preferred
· Experience in international drug shipment
· Experience in IRT design and development
· Highly motivated, creative, hands-on with the ability to work in a fast-paced environment
· Ability to communicate effectively and work in team-based environment
Erasca, Inc, is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex, race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.