The Clinical Development Director will lead clinical studies from protocol design through execution, collaborating with cross-functional teams to manage CROs and data quality. They will also author regulatory documents and leverage AI tools to optimize clinical trial processes across various indications.
The Global Regulatory Strategy Director will lead the development and execution of innovative regulatory strategies for the company's small-molecule clinical pipeline. This role involves representing the company in interactions with global health authorities and providing regulatory guidance to cross-functional project teams.
The Medical Monitoring Director will serve as the sponsor physician for clinical trials, overseeing medical monitoring activities and safety assessments. They will also lead the development of an in-house medical monitoring team and manage the clinical integration of AI tools for safety monitoring.
The Senior CMC Project Manager will lead portfolio-level planning and execution for small-molecule assets from tox supplies through Phase 2 scale-up. They will manage external CDMO relationships, oversee budgets, and ensure regulatory submissions remain on track.
Lead the DMPK and clinical pharmacology strategy across discovery and development programs from candidate nomination through regulatory submission. Oversee PK/PD study design, analysis, and interpretation while partnering with cross-functional teams to integrate nonclinical data into clinical development plans.
The VP of Clinical Biostatistics will provide strategic leadership and operational oversight for the design, analysis, and reporting of clinical trials. This role involves building and leading a high-performing team while collaborating with cross-functional stakeholders to drive clinical programs and regulatory submissions.
The director will act as a strategic partner to the Asset Entrepreneur, overseeing end-to-end program execution and cross-functional operations. They are responsible for translating complex scientific and operational data into clear insights for the C-suite and Board to drive decision-making.
The Clinical Development Director will own the core clinical development plan and design the first-in-human strategy for novel therapeutic assets. They will also build and manage KOL and site networks while shaping translational and biomarker strategies to ensure successful proof-of-mechanism readouts.
The Sr. Clinical Development Director will collaborate with the VP of clinical development on asset strategy and lead key study activities. This role involves designing new clinical protocols, analyzing data, and communicating findings to stakeholders.
