Project, Program, & Portfolio Management
Work closely with cross-functional project teams to develop strategies, plans, timelines, and budgets while identifying and mitigating risks to align with corporate goals. Manage and track project execution to ensure timely completion. Prioritize projects within the portfolio to support changes in corporate strategy and maintain transparent communication with the C-suite and executive team to ensure efficient collaboration.
Corporate Alliance Management & Business Development
Collaborate with project team leads and external biopharma partners to define alliance goals, establish core teams, facilitate meetings, and ensure objectives are achieved. Partner with C-suite and executive team to shape business development and corporate strategy, prepare presentation materials, and negotiate leads.
Vendor selection & oversight
Help identify and select domestic and global CRO/CDMO selection; provide tech transfer and study oversight including in vivo efficacy, GLP Tox, analytical assay method development and validation, process development, GMP manufacturing, Stability testing, and clinical trials.
Establish PMO
Develop Project Management Office (PMO)
processes and systems to ensure a unified and efficient project portfolio. Integrate best practices, tools, and governance structures to streamline project management operations.
Technical support
Help with translational research and preclinical study design, bioassay development, and biomarkers identification. Develop Clinical Development Plan, and Target Product Profile (TPP).
Medical and Regulatory Writing, Biostatistics and Data Management
In collaboration with partners, prepare INDs, protocols, Investigator Brochures. and NDAs/BLA, and CSR, and provide biostatistics and data management support
