Discovery Center Clinical Pharmacology Associate Director BJ-00000KWK
Description
- Responsible for designing, developing and implementing clinical pharmacology plans and strategies for supporting end-to-end projects initiated by China R&D. Responsible for the design of studies to evaluate candidate drugs’ pharmarcokinetics (PK) and pharmacodynamics (PD) clinically.
- Responsible for providing Clin Pharm contributions to China regulatory submissions and approvals: Designing & conducting bridging China PKPD studies, providing strategic supports in liaison with global Clin Pharm
- Responsible for delivering quantitative pharmacology and modeling & simulation supports to discovery of both small molecules & biologics, early to late clinical development, and post-marketing development in China R&D organization. Work collaboratively with key functional partners and apply quantitative ClinPharm tools to guide NME selection, dose / dose regimen selection, predict clinical response and study outcomes, and to optimize study design
- With minimal guidance from ClinPharm Head, provide appropriate dosing recommendations for special populations (eg, drug interaction, food effect, pharmacogenomic effect, pediatric, elderly)
- Has overall scientific accountability for ClinPharm studies and ClinPharm components of other studies
- With minimal guidance from ClinPharm Head, prepare ClinPharm contributions to regulatory documents including IBs, End of Phase 2a / 2 meetings, NDA / MAA submissions, postapproval filings, and responses to regulatory questions
- As appropriate, represent ClinPharm at relevant regulatory meetings (eg, End of Phase 2a / 2, pre-NDA / MAA, Advisory Committee meetings)
- Responsible for the consistency, quality, compliance, and timeliness of clinical PK and PK/PD input into Phase I to III protocols, data analysis, and PK and PK/PD sections of investigator brochures, study reports, regulatory documents, and other documents in accordance with general standards, guidelines, and processes
- Provide leadership, direction, and training to other clinical pharmacology staff supporting the program, including liaison with CRO counterparts, as applicable
- Serves as member of the Clinical Development Team and Compound Development Team, where appropiate, for all clinical PK and PK/PD aspects of development projects and programs.
- Contributes to the identification, characterization, and validation of potential biomarkers and/or surrogate markers and measurements in non-clinical and clinical studies
- Assist in evaluation of in-licensing opportunities for clinical PK and PK/PD components
- Present and / or publish scientific data at conferences and in peer-reviewed journals
- Stay abreast of new emerging technologies in relevant scientific fields
- Liaise with key functional partners to provide product differentiation strategies based on a compound's key ClinPharm attributes
- Maintain compliance with Credo standards, Health Care Compliance, and Business Integrity
Qualifications
Minimum Qualifications / Experiences
· MS or Pharm D degrees with 7 years of pharmaceutical development experience
· PhD or equivalent degrees with 5 years of pharmaceutical development experience
Minimum Technical Knowledge and Skills
· Demonstrated competency in PK/PD modeling & simulation
· Experience in the use of WinNonlin, NONMEM, R or S-plus, database management, or related scientific software
· Working knowledge of Clinical Pharmacology, PK/PD modeling concepts and basic statistics
· Good understanding of clinical drug development and the overall pharmaceutical R&D process
· Working knowledge of US, European, and Asian regulatory requirements and guidelines
· Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s)
· Ability to lead and / or oversee multiple smaller ClinPharm programs
· Has established a good level of expertise and scientific reputation through publications and presentations
Minimum Non-Technical Competencies and Skills
· Fluent in written and spoken English
· Good written and oral communication skills and able to communicate effectively with individuals and groups in the organization (communication)
· Ability to build and maintain effective working relationships inside and outside the department; strong aptitude for working in a cross-functional team environment; demonstrates commitment to team's expectations and decisions (building strategic working relationships)
· Ability to multi-task, prioritize assignments, and work under pressure, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner (planning, organization, managing the job)
· Assume responsibility and accountability for successfully completing assignments or tasks, proactively taking action to accomplish objectives, and setting high standards of performance (delivery of results)
· Ability to diagnose issues and problems, develop alternative solutions, take decisions, and act with a sense of urgency; exercises good judgment in assessing situations and deciding next steps (decision making)
· Good sense of cultural sensitivity and diversity (cultural diversity)
· Actively identify new areas for learning and application to the job (continuous learning)
· Self-motivated and able to work independently with minimal supervision (personal accountability)
· Understands the broader development organization
· Ability to inspire, motivate, and provide effective leadership to team members
· Courage to stand alone on ideas and opinions which differ from others; takes risks where necessary (prudent risk taking)
Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Johnson & Johnson Medical China (7052)
Job Function: Clinical Data Management
Description
- Responsible for designing, developing and implementing clinical pharmacology plans and strategies for supporting end-to-end projects initiated by China R&D. Responsible for the design of studies to evaluate candidate drugs’ pharmarcokinetics (PK) and pharmacodynamics (PD) clinically.
- Responsible for providing Clin Pharm contributions to China regulatory submissions and approvals: Designing & conducting bridging China PKPD studies, providing strategic supports in liaison with global Clin Pharm
- Responsible for delivering quantitative pharmacology and modeling & simulation supports to discovery of both small molecules & biologics, early to late clinical development, and post-marketing development in China R&D organization. Work collaboratively with key functional partners and apply quantitative ClinPharm tools to guide NME selection, dose / dose regimen selection, predict clinical response and study outcomes, and to optimize study design
- With minimal guidance from ClinPharm Head, provide appropriate dosing recommendations for special populations (eg, drug interaction, food effect, pharmacogenomic effect, pediatric, elderly)
- Has overall scientific accountability for ClinPharm studies and ClinPharm components of other studies
- With minimal guidance from ClinPharm Head, prepare ClinPharm contributions to regulatory documents including IBs, End of Phase 2a / 2 meetings, NDA / MAA submissions, postapproval filings, and responses to regulatory questions
- As appropriate, represent ClinPharm at relevant regulatory meetings (eg, End of Phase 2a / 2, pre-NDA / MAA, Advisory Committee meetings)
- Responsible for the consistency, quality, compliance, and timeliness of clinical PK and PK/PD input into Phase I to III protocols, data analysis, and PK and PK/PD sections of investigator brochures, study reports, regulatory documents, and other documents in accordance with general standards, guidelines, and processes
- Provide leadership, direction, and training to other clinical pharmacology staff supporting the program, including liaison with CRO counterparts, as applicable
- Serves as member of the Clinical Development Team and Compound Development Team, where appropiate, for all clinical PK and PK/PD aspects of development projects and programs.
- Contributes to the identification, characterization, and validation of potential biomarkers and/or surrogate markers and measurements in non-clinical and clinical studies
- Assist in evaluation of in-licensing opportunities for clinical PK and PK/PD components
- Present and / or publish scientific data at conferences and in peer-reviewed journals
- Stay abreast of new emerging technologies in relevant scientific fields
- Liaise with key functional partners to provide product differentiation strategies based on a compound's key ClinPharm attributes
- Maintain compliance with Credo standards, Health Care Compliance, and Business Integrity
Qualifications
Minimum Qualifications / Experiences
· MS or Pharm D degrees with 7 years of pharmaceutical development experience
· PhD or equivalent degrees with 5 years of pharmaceutical development experience
Minimum Technical Knowledge and Skills
· Demonstrated competency in PK/PD modeling & simulation
· Experience in the use of WinNonlin, NONMEM, R or S-plus, database management, or related scientific software
· Working knowledge of Clinical Pharmacology, PK/PD modeling concepts and basic statistics
· Good understanding of clinical drug development and the overall pharmaceutical R&D process
· Working knowledge of US, European, and Asian regulatory requirements and guidelines
· Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s)
· Ability to lead and / or oversee multiple smaller ClinPharm programs
· Has established a good level of expertise and scientific reputation through publications and presentations
Minimum Non-Technical Competencies and Skills
· Fluent in written and spoken English
· Good written and oral communication skills and able to communicate effectively with individuals and groups in the organization (communication)
· Ability to build and maintain effective working relationships inside and outside the department; strong aptitude for working in a cross-functional team environment; demonstrates commitment to team's expectations and decisions (building strategic working relationships)
· Ability to multi-task, prioritize assignments, and work under pressure, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner (planning, organization, managing the job)
· Assume responsibility and accountability for successfully completing assignments or tasks, proactively taking action to accomplish objectives, and setting high standards of performance (delivery of results)
· Ability to diagnose issues and problems, develop alternative solutions, take decisions, and act with a sense of urgency; exercises good judgment in assessing situations and deciding next steps (decision making)
· Good sense of cultural sensitivity and diversity (cultural diversity)
· Actively identify new areas for learning and application to the job (continuous learning)
· Self-motivated and able to work independently with minimal supervision (personal accountability)
· Understands the broader development organization
· Ability to inspire, motivate, and provide effective leadership to team members
· Courage to stand alone on ideas and opinions which differ from others; takes risks where necessary (prudent risk taking)
Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Johnson & Johnson Medical China (7052)
Job Function: Clinical Data Management