Qualification Required :Education: MD or PhD in Medicine, Pharmacology, Clinical Research or equivalent with 15 years of experience (5 years in leading cross-functinal team).
Prior experience working with global regulatory agencies such as the FDA, EMA, etc. Experience in biologics/CGT experience desirable. ...
Familiarity with pharmacovigilance and safety monitoring in clinical trials. Job Description Leadership and Strategy:
Develop and execute clinical development strategies that align with the organization &39;goals and timelines.
Provide leadership to cross-functional teams, including Clinical Sciences, Clinical Quality & Compliance, Statistics Data Management, Clinical Pharmacology, and Clinical
Operations.
Ensure alignment of clinical activities with regulatory requirements, industry standards,and best practices.
Clinical Program Oversight:
Oversee the design, implementation, and management of all clinical studies, from Phase I to Phase IV.
Ensure that clinical trials are conducted according to GCP (Good Clinical Practice)
guidelines, ICH (International Conference on Harmonization) standards, and other relevant regulations.
Quality and Compliance:
Lead the Clinical Quality & Compliance team to ensure adherence to regulatory requirements and company policies.
Develop and maintain systems for quality assurance, auditing, and inspection readiness forclinical trials.
Ensure compliance with data privacy regulations (e.g., GDPR, HIPAA) in data management and clinical operations.
Data Management and Analysis:
Oversee the Statistics Data Management team to ensure robust data collection, analysis, and interpretation.
Collaborate with biostatistics, data managers, and clinical scientists to ensure the accuracy of clinical study data and its alignment with regulatory submission requirements.
experience
14show more Qualification Required :Education: MD or PhD in Medicine, Pharmacology, Clinical Research or equivalent with 15 years of experience (5 years in leading cross-functinal team).
Prior experience working with global regulatory agencies such as the FDA, EMA, etc. Experience in biologics/CGT experience desirable.
Familiarity with pharmacovigilance and safety monitoring in clinical trials. Job Description Leadership and Strategy:
Develop and execute clinical development strategies that align with the organization &39;goals and timelines.
Provide leadership to cross-functional teams, including Clinical Sciences, Clinical Quality & Compliance, Statistics Data Management, Clinical Pharmacology, and Clinical
Operations.
Ensure alignment of clinical activities with regulatory requirements, industry standards,and best practices.
Clinical Program Oversight:
Oversee the design, implementation, and management of all clinical studies, from Phase I to Phase IV.
Ensure that clinical trials are conducted according to GCP (Good Clinical Practice)
guidelines, ICH (International Conference on Harmonization) standards, and other relevant regulations.
...
Quality and Compliance:
Lead the Clinical Quality & Compliance team to ensure adherence to regulatory requirements and company policies.
Develop and maintain systems for quality assurance, auditing, and inspection readiness forclinical trials.
Ensure compliance with data privacy regulations (e.g., GDPR, HIPAA) in data management and clinical operations.
Data Management and Analysis:
Oversee the Statistics Data Management team to ensure robust data collection, analysis, and interpretation.
Collaborate with biostatistics, data managers, and clinical scientists to ensure the accuracy of clinical study data and its alignment with regulatory submission requirements.
experience
14show more
