Associate Director/ Director/ Senior Medical Director, Nephrology

Position Overview

SanegeneBio is a global, venture-backed, clinical-stage biotech company advancing best-in-class genetic medicines. Powered by our proprietary LEAD™ siRNA delivery and chemistry platform, we are developing innovative RNAi therapeutics for autoimmune, cardiovascular, obesity and metabolic diseases. With R&D operations across the U.S. and China, we foster a culture of scientific rigor, collaboration, operational excellence, and continuous innovation.

We are seeking an experienced Nephrologist-trained physician-scientist to serve as Medical Lead for a global Phase 3 program in kidney disease. You will own the medical and scientific direction of the global pivotal study, from protocol design, execution, through data readout and regulatory submission, and will serve as the medical voice of the program for internal teams, CROs, investigators, regulators, and external experts. This is a senior role with broad scope and executive visibility.

Key Responsibilities

Clinical Strategy & Trial Leadership

•  Serve as the medical lead for the global Phase 3 trial, with accountability for medical and scientific integrity.

• Shape the clinical development plan, protocol, statistical analysis plan (SAP, together with program biostatistician), and informed consent documents, including endpoint selection, eligibility criteria, and dose and regimen rationale.

• Provide ongoing medical input on study conduct, including protocol deviations, eligibility questions, enrollment strategy, and site and country feasibility.

• Represent Clinical Development in program governance and contribute to portfolio and lifecycle strategy for the nephrology franchise.

Medical Monitoring & Patient Safety

• Lead medical monitoring in partnership with the CRO and Pharmacovigilance, including review of safety signals, adverse events of special interest, and nephrology-specific safety parameters (e.g., eGFR, proteinuria, electrolytes, infections).

• Participate in safety review meetings, DMC/IDMC interactions, and risk-benefit assessments.

• Review and interpret clinical data listings, TLFs, and aggregate safety and efficacy data.

Cross-Functional & External Engagement

• Partner with Regulatory Affairs, Biostatistics, Clinical Operations, Clinical Pharmacology, PV, CMC, and Commercial/BD teams.

• Lead or support regulatory interactions (FDA, EMA, NMPA, and others), including briefing documents, meeting preparation, and responses to health authority questions.

• Build and maintain relationships with key opinion leaders (KOLs), steering committee members, and principal investigators; organize advisory boards and investigator meetings.

• Support due diligence, partnership discussions, and external scientific communication as needed.

People & Vendor Leadership

• Provide medical leadership and mentorship to clinical scientists, medical monitors, and other team members as the team grows.

• Oversee CRO and external vendor medical performance.

Scientific Output & Documentation

• Author or review key clinical documents: protocols, Investigator's Brochure, CSR, regulatory submission modules (e.g., Module 2.5, 2.7), and DSURs.

• Contribute to abstracts, manuscripts, and congress presentations (e.g., ASN, ERA, ISN).

• Stay current on the nephrology treatment landscape, competitor programs, and evolving regulatory standards and endpoints.
  

Qualifications

• MD (or equivalent medical degree) from an accredited institution.

• At least 10 years of relevant professional experience following completion of medical training, including nephrology specialty training and at least 2 years of clinical practice as a physician. Within this overall experience, at least 2 years of industry experience in clinical drug development within a biotechnology or pharmaceutical company, including a proven track record serving as Medical Lead (or equivalent, such as lead medical monitor or clinical lead) on clinical development programs.

• Working knowledge of ICH-GCP, global regulatory requirements, and clinical trial design.

• Strong ability to interpret clinical and safety data and communicate clearly to both technical and non-technical audiences.

• Fluent in English, both written and spoken, with the ability to author and review regulatory documents, clinical study documents, and scientific publications in English; lead the medical and scientific components of regulatory interactions and meetings with health authorities; and engage effectively in scientific discussions with key opinion leaders (KOLs). Professional fluency in Chinese is a plus for China-based collaboration.

• Preferred Qualifications: 1) MD/PhD strongly preferred; 2) Experience leading Phase 2/3 or pivotal trials, ideally in glomerular or immune-mediated kidney disease (e.g., IgAN, C3G, IC-MPGN, lupus nephritis, FSGS, membranous nephropathy) or complement-targeted therapies; 3) Experience as medical lead for a global, multi-regional trial; 4) Direct experience with FDA, EMA, and/or NMPA interactions, including pre-IND, EOP2, pre-NDA/BLA or equivalent meetings; 5) Familiarity with rare disease and pediatric development (e.g., PIP/PSP); 6) Publications in nephrology or clinical research; established relationships with the global nephrology community; 7) Experience managing CROs and vendors, and mentoring or managing medical staff.

• Key Competencies: 1) Strategic thinking with hands-on execution in a lean biotech environment; 2) Sound medical judgment and a strong patient-safety mindset; 3) Cross-cultural collaboration across US, EU, and China teams; 4) Clear, concise scientific writing and presentation skills; 5) Leadership, ownership, and comfort operating with ambiguity.

Interested candidates: please send your information to hr@sanegenebio.com.