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Job Description:

Date: 1/17/2025

Location: China

Reporting to: Asia Pacific Liaison for Clinical Pharmacology & Pharmacometrics

Objective of Position

The China Group Leader for Clinical Pharmacology and Pharmacometrics (CPP-C) oversees the management of Clinical Pharmacology Leaders in China and acts as the local representative for CPP, including on behalf of the pharmacometrics team in China.

This leader is charged with integrating Clinical Pharmacology principles, Model Informed Drug Development approaches, Operational Excellence, and Scientific Integrity into the clinical development strategy and study design from a clinical pharmacology perspective for China developments. The China Group Leader oversees preparation of clinical pharmacology components of China submission documents and regulatory interactions in alignment with the global team.

The China CPP Group Leader is responsible for executing operations and maintaining excellence to deliver clinical pharmacology related analyses and deliverables supporting portfolio.

Main Accountabilities

·Facilitates the maintenance of the CPP-C organization to effectively implement clinical pharmacology and pharmacometrics principles in support of development activities in China:

oRecruits, develops, and retains talent, and is accountable for professional and leadership development and training.

oFosters an environment that promotes excellence, rigor, innovation, and encourages individuals to develop their potential.

oCreates an environment that supports the company' s commitment to equal employment opportunity and values a diverse workforce.

·Provides strategic leadership for designing and developing R& D plans for China including early assessment of local strategy, as well as formulating China-based regulatory and scientific strategies from a clinical pharmacology perspective.

·Oversees and manages the operations of CPP-C.

·Ensures performance management and executes functional responsibilities in accordance with relevant SOPs, regulatory requirements, and the Johnson & Johnson Credo principles.

Other Accountabilities & Tasks

• Oversees the clinical pharmacology discipline concerning all development programs within the China portfolio. Contributes to drug development decision-making by facilitating and advancing drug development milestone transitions, regulatory submissions, focusing on the application of clinical pharmacology principles.
• Demonstrates influence as a key contributor to strategic long-term decision-making by Senior Management to drive the China strategy for J& J IM R& D.
• Mentor coach, train and develop (in)direct reports, and evaluate performance.
• Promote innovation, creativity, and stimulate individuals in the department to pursue new scientific endeavors.
• Establishes and fosters good working relationship with other departments in China and global R& D and external stakeholders (e.g., CDE, Academic Societies, Pharmaceutical Industry Associations).

Minimum Qualifications / Experience

• PhD in Pharmaceutical Sciences, or related field plus a minimum of 10 years’ experience of clinical development in the pharmaceutical industry; or M.S. in Pharmaceutical Sciences or related field plus a minimum of 14 years’ experience in the pharmaceutical industry.
• Minimally 5 years of people management experiences in R& D functions in the pharmaceutical industry.

Minimum Technical Knowledge and Skills

• Extensive knowledge of clinical pharmacology, drug development, regulatory requirements and guidelines enabling colleagues to create alternate/new strategies representing CP/PMx, and across functional lines for multiple types of therapies (e.g., small and large molecules, cell-based therapies) for CDE.
• Extensive experience in regulatory communications, including preparation of summary documents, responses to regulatory queries, and presenting oral and written content to regulatory authorities.
• Comprehensive knowledge of sourcing strategies, resource management, and organizational impact.
• Demonstrated leadership and decision-making skills.
• Comprehensive knowledge of regulatory circumstance including trends and regulatory guidance documents, especially related to applying clinical pharmacology and pharmacometrics principles for FDA and EMA in addition to CDE.
• Good understanding of advanced analysis methods (e.g., population analysis, PBPK, MBMA, QSP).
• Highly effective written, oral, and interpersonal communication skills (both in Chinese and English), including excellent leadership, innovative thinking, decision-making skills and proven ability to foster team productivity and cohesiveness, act as a change agent, and adapt to a rapidly changing organization and business environment.
• Demonstrated innovative thinking to allow for optimal design and implementation of R& D strategies from clinical pharmacology viewpoint.

Other Requirements

Estimated both domestic and international travel of about 5% of time.