Johnson & Johnson 职业机会
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Senior Manager, Clinical Pharmacology
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.
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 organization and 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).
· Estimated travel of about 10% - 15% of time.