Clinical/Development Principal
Job SummaryWe are seeking a Clinical Development Leader for our technology client in Central New Jersey.
The Clinical/Development Principal will be strong in Pharmaceutical and CRO industry experience, stretching across R&D and a strong knowledge of Pharma.
Understand problem space in clinical/development and can leverage advanced analytics AI/ML along with their strong understanding of the LS/Pharma market and can bring their POV of the challenges in the Clinical/development space and align it with services.
Primary ResponsibilitiesSolid understanding of early development through pivotal trials, submissions, inspections, and regulatory approvals.
Understanding of optimize workflow between upstream and downstream activities to decrease cycle times and improve data quality in clinical trials.
Understanding oversee clinical trial sites, investigators, and vendors.
Experienced pharmaceutical development professional with a proven track record leading global programs with cross-functional teams.
Understands successful completion of programs in all phases of development including preclinical selection, Phase 1, 2 and 3 trials, regulatory submissions, and post approval studies.
Understanding of quality standards including ICH/GCP and applicable regulations.
Understanding the Pharma cross-functional teams, including medical affairs, regulatory affairs, and commercial.
Education and ExperienceMinimum of B.
S degree or higher degree (M.
S.
, MPH, M.
D.
, Pharm D, PhD etc)Minimum 10-12 years of experience in a Clinical Operations role working on international/global Clinical studies within the Pharmaceutical/Biotechnology Industries or with a CROWorking with vendors in the Tech consulting space that support Pharma companies and know how to leverage the latest digital technologiesExperience in Oncology, Infectious diseases, HIV, Immunology/respiratory and dermatology Recommended Skills Artificial Intelligence Biotechnology Clinical Development Clinical Works Data Analysis Data Quality Estimated Salary: $20 to $28 per hour based on qualifications.
The Clinical/Development Principal will be strong in Pharmaceutical and CRO industry experience, stretching across R&D and a strong knowledge of Pharma.
Understand problem space in clinical/development and can leverage advanced analytics AI/ML along with their strong understanding of the LS/Pharma market and can bring their POV of the challenges in the Clinical/development space and align it with services.
Primary ResponsibilitiesSolid understanding of early development through pivotal trials, submissions, inspections, and regulatory approvals.
Understanding of optimize workflow between upstream and downstream activities to decrease cycle times and improve data quality in clinical trials.
Understanding oversee clinical trial sites, investigators, and vendors.
Experienced pharmaceutical development professional with a proven track record leading global programs with cross-functional teams.
Understands successful completion of programs in all phases of development including preclinical selection, Phase 1, 2 and 3 trials, regulatory submissions, and post approval studies.
Understanding of quality standards including ICH/GCP and applicable regulations.
Understanding the Pharma cross-functional teams, including medical affairs, regulatory affairs, and commercial.
Education and ExperienceMinimum of B.
S degree or higher degree (M.
S.
, MPH, M.
D.
, Pharm D, PhD etc)Minimum 10-12 years of experience in a Clinical Operations role working on international/global Clinical studies within the Pharmaceutical/Biotechnology Industries or with a CROWorking with vendors in the Tech consulting space that support Pharma companies and know how to leverage the latest digital technologiesExperience in Oncology, Infectious diseases, HIV, Immunology/respiratory and dermatology Recommended Skills Artificial Intelligence Biotechnology Clinical Development Clinical Works Data Analysis Data Quality Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
