Johnson & Johnson Careers

Senior Manager, Clinical Pharmacology

Shanghai, China
Pharmacokinetics


Job Description

Requisition ID: 1700166329W

·         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/AP regulatory submissions and approvals: Designing & conducting bridging China/AP 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.

 

·         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.

·         Prepare ClinPharm contributions to regulatory documents including IBs, End of Phase 2a / 2 meetings, NDA / MAA submissions, postapproval filings, and responses to regulatory questions.

·         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 junior clinical pharmacology staff supporting the ClinPharm 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; identify new opportunities for scientific and technical advancement within the division.

·         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

·      PhD or MD  or equivalent degrees, generally 5 years of pharmaceutical development experience.

·      Ability to lead and /oversee mutiple smaller ClinPharm  programs independantly.

·      Broad clinical pharmacology experience and M&S experience is required.

·      Broad drug development experience in one or multiple Therapeutic Areas with a focus on oncology, respiratory, immunology and hepatitis compounds.

 

 

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.

·      Good knowledge of Clinical Pharmacology,  PK/PD modeling concepts and basic statistics.

·      Excellent understanding of clinical drug development and the overall pharmaceutical R&D process.

·      Good understanding of US, European, and Asian regulatory requirements and guidelines.

·      Good understanding of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s).

 

Minimum Non-Technical Competencies and Skills

·      Fluent in written and spoken English.

·      Excellent written and oral communication skills and able to communicate effectively with individuals and groups in the organization (communication).

·      Ability to influence, 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 organizationand navigates across them with assistance from management.

·      Ability to inspire, motivate, and provide effective leadership to team members; develops direction and structure for the team.

·      Courage to stand alone on ideas and opinions which differ from others; takes risks where necessary (prudent risk taking).

 

 

Other Requirements

·      Estimated travel of about 10% - 15% of time.

 


Primary Location
China-Shanghai-Shanghai
Organization
J&J (China) Investments Ltd (7046)
Job Function
Pharmacokinetics
Requisition ID
1700166329W