- Acting VP Clinical Development Operations: Jul 2017-Oct 2018
Managed staff and functions of program/study operations, biostatistics & data management, medical writing, safety & pharmacovigilance, clinical supplies, and clinical contracting across rare disease and biosimilar portfolio. Implemented a new working model, spearheaded the building of a strong team team to support a growing portfolio, and lead the hiring of permanent head of department.
- Development of Standard Operations Procedures and inspection readiness: Nov 2018 - May 2019
Proposed and secured approval for suite of new and revised procedurs in support of overall company quality goals. Created, revised and trained staff on more than 20 procedures to support inspection readiness.
- Subcontractor placement and contracting (study leadership for gene therapy/rare disease): April 2018-present
- Vendor management evaluation and study delivery improvement (phase 3 gene therapy/rare disease): May 2019-present
- Study oversight for Phase 1 studies based in Australia, Phase 2 planning for rare disease assests, and SOP development: March 2019-present