China CPP Group Leader Oncology
- Beijing
- Permanent
- Full-time
- Facilitates the maintenance of the CPP-C organization to effectively implement clinical pharmacology and pharmacometrics principles in support of development activities in China for development projects in Oncology:
- Recruits, develops, and retains talent, and is accountable for professional and leadership development and training.
- Fosters an environment that promotes excellence, rigor, innovation, and encourages individuals to develop their potential.
- Creates 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 Oncology.
- Ensures performance management and executes functional responsibilities in accordance with relevant SOPs, regulatory requirements, and the Johnson & Johnson Credo principles.
- Oversees the clinical pharmacology discipline concerning the Oncology 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).
- 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.
- 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. Clinical Pharmacology experience in Oncology is required.
- 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.