The Director of CMC Regulatory Affairs will lead global regulatory strategies for biologic and combination products, including the preparation of submissions and briefing documents. They will serve as the primary regulatory lead on cross-functional teams and provide guidance on manufacturing, quality, and lifecycle management.
The Director of Clinical Operations will lead cross-functional study execution teams and oversee the strategic and operational execution of clinical trials. They are responsible for managing trial budgets, selecting vendors, and ensuring compliance with regulatory standards throughout the drug development process.
The Medical Director will lead the design, execution, and oversight of clinical trials in nephrology while serving as the medical monitor to ensure patient safety. They will also collaborate with cross-functional teams and regulatory bodies to advance the company's clinical pipeline.
The Senior Clinical Scientist will lead the execution of Phase 2 and 3 clinical trials in nephrology, focusing on protocol development and scientific oversight. They will manage data review, medical monitoring, and collaborate cross-functionally to ensure regulatory compliance and data quality.
The role manages the end-to-end document lifecycle and training processes, including creation, review, and archival of controlled documentation. It also involves establishing training matrices and ensuring audit-ready traceability for pharmaceutical R&D functions.
Lead immunology-driven research strategy and mechanism-of-action studies to support pipeline programs and indication assessments. Collaborate with cross-functional teams to align preclinical findings with clinical strategy and identify new targets for pipeline expansion.
The Director of Clinical Compliance ensures clinical trials adhere to ICH-GCP, regulatory requirements, and internal quality standards. This role leads initiatives in vendor oversight, inspection readiness, and the management of compliance metrics and CAPAs.
Provides QA oversight for the product pipeline and contract manufacturers (CMOs) to ensure compliance with GMP requirements. Manages quality records, batch release decisions, and collaborates with cross-functional teams to mitigate GMP-related risks.
