Role Summary
The Senior Medical Director will be focused on Kidney Disease and related conditions that impact kidney function. In this role, you will work at the forefront of early clinical and translational research within CVRM, progressing a diverse pipeline of small and large molecules in active clinical programs.
Responsibilities
- Lead early Phase I–II global trials in kidney disease: clinical strategy, protocol design, study conduct, monitoring, data interpretation, and reporting, ensuring scientific integrity, patient safety, and regulatory compliance.
- Provide clinical leadership to cross-functional teams; integrate preclinical insights into early clinical plans and seamless transitions to late phase development.
- Contribute to regulatory interactions and documentation (e.g., CTAs, INDs, safety updates, annual reports).
- Advance the development and validation of nonclinical and surrogate endpoints (including imaging and biomarkers).
- Represent TSCD internally and externally through presentations, publications, and scientific forums; engage with external experts and translate insights into strategy and study design.
- Help evolve trial operations and site engagement to improve speed, quality, and inclusivity in early studies.
- Collaborate across CVRM on programs in heart failure, type 2 diabetes, obesity, and metabolic dysfunction-associated steatohepatitis, given their intersection with kidney disease.
Qualifications
- MD, MBBS or MD/PhD with established clinical or research expertise in the treatment of kidney diseases.
- Minimum of 5 years of clinical research in academia and/or the pharmaceutical/biotechnology industry.
- Experience designing, executing, monitoring, interpreting, and overseeing safety in early clinical and translational trials preferred.
- Strong command of biomarkers, surrogate endpoints, and biostatistics, supported by a robust publication record.
- Well developed interpersonal skills, effective teamwork, and the ability to engage stakeholders effectively across functions, geographies, and disciplines.
Skills
- Clinical trial leadership
- Cross-functional collaboration
- Regulatory documentation and interactions
- Biomarkers and biostatistics
- Strategic planning for early clinical development
Education
- MD, MBBS, or MD/PhD (required)