Lead the pre-clinical and clinical investigation of PK/PD, safety, and efficacy relationships for novel T-cell engagers. Collaborate cross-functionally to inform dose optimization, regulatory submissions, and candidate selection.
Xencor
7 Remote Job Openings at Xencor
Lead the pre-clinical and clinical investigation of PKPD, safety, and efficacy relationships for novel T-cell engagers and immune-based therapeutics. Build population models to inform dose selection, support regulatory interactions, and collaborate cross-functionally to optimize dose-escalation and RP2D decisions.
Oversees all drug safety and pharmacovigilance processes, including the analytical assessment of safety data and signal detection for assigned products. Leads the authoring of aggregate safety reports and ensures compliance with global regulatory requirements and safety standards.
Facilitate the initiation and completion of clinical development programs in Inflammatory Bowel Disease and other autoimmune programs. This includes creating clinical trial documents, monitoring medical aspects of global trials, and analyzing clinical data.
Lead the initiation and completion of clinical development programs for Inflammatory Bowel Disease and other autoimmune conditions. This includes designing protocols, monitoring safety, and interpreting data for randomized, placebo-controlled trials.
Lead the initiation and completion of clinical development programs for Inflammatory Bowel Disease and other autoimmune conditions. This includes designing protocols, monitoring medical aspects of global trials, and interpreting clinical data for CSRs and publications.
Oversees all aspects of drug safety and pharmacovigilance processes, including the analytical assessment of safety data for assigned products. Leads signal evaluation, authors aggregate safety reports, and ensures compliance with global regulatory requirements.
