Capleo Global
Regulatory Studio - Associate Director, Precision Medicine & Digital Health
Capleo Global, Short Hills, New Jersey, us, 07078
Job Title: Regulatory Studio - Associate Director, Precision Medicine & Digital Health
Location: Short Hills,NJ
Duration: 6 Months
Must have:
1. In vitro diagnostics regulations in precision medicine under US and EU regulations
2. Worked on drug trials that use a biomarker to select patients into the trial, include but not limited to, understand clinical trial assay (CTA) requirements with diagnostic partners, sample testing/shipping regulations in different countries, and CDx development requirements
3. Has built a diagnostic device regulatory strategy plan for a biomarker-driven trial
4. Kept up to date on Digital Health technology regulatory requirements and worked on a digital pathology or digital health product in a drug
Responsibilities:
" Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas
" Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.
" Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers.
" Ensure consistent positions are presented in responses to global Health Authority (HA) queries.
" Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the Global Regulatory sub-team, develop global submission plans and HA interaction plans.
" Provide input into the development of protocol synopses and protocols. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
" Contribute in the developing of target labeling.
Key Competencies
" Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within Client and across alliance.Experience utilizing leadership techniques to drive a team through the stages of team development.
" Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
" Experience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsor.
" Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry. Experience coordinating communications within teams and across functions.
" Experience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodies.
" Ability to apply project management techniques within teams and effectively manage meetings.
" Demonstrated ability to breakdown complex, scientific content into logical components.
" Ability to coordinate global activities, facilitate issue resolution and conflict management.
" Demonstrated ability to drive quality decision-making and ability to organize/prioritize tasks.
" Demonstrated ability to negotiate with and influence others.
" Understanding of strategic and tactical role for the drug development process.
" Understanding of general global regulatory requirements for drugs in development.
" Understanding of R&D process and specific regulatory responsibilities/deliverables for the company decision points.
Degree / Experience Requirements
" Bachelor s degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience
Location: Short Hills,NJ
Duration: 6 Months
Must have:
1. In vitro diagnostics regulations in precision medicine under US and EU regulations
2. Worked on drug trials that use a biomarker to select patients into the trial, include but not limited to, understand clinical trial assay (CTA) requirements with diagnostic partners, sample testing/shipping regulations in different countries, and CDx development requirements
3. Has built a diagnostic device regulatory strategy plan for a biomarker-driven trial
4. Kept up to date on Digital Health technology regulatory requirements and worked on a digital pathology or digital health product in a drug
Responsibilities:
" Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas
" Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.
" Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers.
" Ensure consistent positions are presented in responses to global Health Authority (HA) queries.
" Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the Global Regulatory sub-team, develop global submission plans and HA interaction plans.
" Provide input into the development of protocol synopses and protocols. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
" Contribute in the developing of target labeling.
Key Competencies
" Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within Client and across alliance.Experience utilizing leadership techniques to drive a team through the stages of team development.
" Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
" Experience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsor.
" Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry. Experience coordinating communications within teams and across functions.
" Experience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodies.
" Ability to apply project management techniques within teams and effectively manage meetings.
" Demonstrated ability to breakdown complex, scientific content into logical components.
" Ability to coordinate global activities, facilitate issue resolution and conflict management.
" Demonstrated ability to drive quality decision-making and ability to organize/prioritize tasks.
" Demonstrated ability to negotiate with and influence others.
" Understanding of strategic and tactical role for the drug development process.
" Understanding of general global regulatory requirements for drugs in development.
" Understanding of R&D process and specific regulatory responsibilities/deliverables for the company decision points.
Degree / Experience Requirements
" Bachelor s degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience