VyBio
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Clinical Development Manager / Director (Chronic Disease)
Location:
Hybrid role | Remote while in the US, with 50% travel commitment to Chinese Headquarters
Must be proficient in Chinese and English
Company:
VyBio Therapeutics, China
Position Overview VyBio is pioneering innovative therapies in chronic disease and oncology, leveraging next-generation small molecules, oligonucleotides, and AI-enabled discovery. We are seeking a highly motivated Clinical Development Manager or Director to lead clinical strategy and execution for our chronic disease pipeline.
Title and compensation will be commensurate with experience.
Key Responsibilities
Clinical Trial Management: Lead end-to-end planning and execution of clinical trials in chronic disease indications, including protocol design, site selection, monitoring, data management, and final reporting; Collaborate closely with investigators (PIs), CROs, and cross-functional internal teams to ensure all trials comply with GCP and regulatory standards; Monitor study progress proactively, identify and resolve operational challenges, and ensure on-time, high-quality delivery of clinical milestones.
Clinical Development Strategy & Regulatory Support: Contribute to the overall medical and clinical development strategy; Support IND/NDA submissions with robust scientific rationale; Analyze and interpret clinical data; author clinical study reports and related documentation; Stay abreast of competitive developments and scientific advances in global chronic disease research to inform R&D decision-making.
Cross-Functional Collaboration: Partner effectively with chemistry, biology, and CMC teams to ensure seamless transition across R&D stages; Serve as the clinical liaison to external experts and academic collaborators, including leading clinician scientists and academicians; Support registration and regulatory submission activities by preparing clinical and medical documentation aligned with NMPA/FDA requirements.
Innovation and Translational Research: Participate in the clinical translation of innovative therapeutic modalities, such as oligonucleotide-based drugs and AI-assisted target and biomarker discovery; Assess and integrate emerging global trends in precision medicine and digital health to strengthen VyBio’s innovation strategy.
Qualifications
M.D; ≥2 years of relevant clinical development experience in internal medicine, cardiology, nephrology, or related fields (experience in sponsor or CRO settings accepted).
Overseas education or work experience preferred.
Strong knowledge of clinical development processes, with proven experience in trial design and operational oversight for chronic diseases.
Skilled in clinical data analysis and interpretation; capable of drafting high-quality clinical study reports.
Familiar with Chinese and international regulatory frameworks (NMPA, FDA, EMA); experience with IND/NDA submissions required.
Excellent written and verbal communication in both Chinese and English.
High sense of ownership, collaboration, and adaptability in a fast-paced, innovative environment.
Referrals increase your chances of interviewing at VyBio by 2x
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Clinical Development Manager / Director (Chronic Disease)
Location:
Hybrid role | Remote while in the US, with 50% travel commitment to Chinese Headquarters
Must be proficient in Chinese and English
Company:
VyBio Therapeutics, China
Position Overview VyBio is pioneering innovative therapies in chronic disease and oncology, leveraging next-generation small molecules, oligonucleotides, and AI-enabled discovery. We are seeking a highly motivated Clinical Development Manager or Director to lead clinical strategy and execution for our chronic disease pipeline.
Title and compensation will be commensurate with experience.
Key Responsibilities
Clinical Trial Management: Lead end-to-end planning and execution of clinical trials in chronic disease indications, including protocol design, site selection, monitoring, data management, and final reporting; Collaborate closely with investigators (PIs), CROs, and cross-functional internal teams to ensure all trials comply with GCP and regulatory standards; Monitor study progress proactively, identify and resolve operational challenges, and ensure on-time, high-quality delivery of clinical milestones.
Clinical Development Strategy & Regulatory Support: Contribute to the overall medical and clinical development strategy; Support IND/NDA submissions with robust scientific rationale; Analyze and interpret clinical data; author clinical study reports and related documentation; Stay abreast of competitive developments and scientific advances in global chronic disease research to inform R&D decision-making.
Cross-Functional Collaboration: Partner effectively with chemistry, biology, and CMC teams to ensure seamless transition across R&D stages; Serve as the clinical liaison to external experts and academic collaborators, including leading clinician scientists and academicians; Support registration and regulatory submission activities by preparing clinical and medical documentation aligned with NMPA/FDA requirements.
Innovation and Translational Research: Participate in the clinical translation of innovative therapeutic modalities, such as oligonucleotide-based drugs and AI-assisted target and biomarker discovery; Assess and integrate emerging global trends in precision medicine and digital health to strengthen VyBio’s innovation strategy.
Qualifications
M.D; ≥2 years of relevant clinical development experience in internal medicine, cardiology, nephrology, or related fields (experience in sponsor or CRO settings accepted).
Overseas education or work experience preferred.
Strong knowledge of clinical development processes, with proven experience in trial design and operational oversight for chronic diseases.
Skilled in clinical data analysis and interpretation; capable of drafting high-quality clinical study reports.
Familiar with Chinese and international regulatory frameworks (NMPA, FDA, EMA); experience with IND/NDA submissions required.
Excellent written and verbal communication in both Chinese and English.
High sense of ownership, collaboration, and adaptability in a fast-paced, innovative environment.
Referrals increase your chances of interviewing at VyBio by 2x
#J-18808-Ljbffr