Senior Director, Clinical Pharmacology
FibroGen
- San Francisco, CA
- Permanent
- Full-time
- Develop strategies in clinical pharmacology and quantitative sciences to meet regulatory requirements
- Drive execution of clinical pharmacology and quantitative sciences vision through execution, interpretation, and presentation of results to project teams, executive review and decision-making bodies
- Proactively and decisively represent and be an effective spokesperson for key principles on cross-functional project teams
- Develop and implement new clinical pharmacology tools and technologies to drive efficient drug development
- Identify, develop, and manage collaborative relationships with vendors to apply state-of-the art population PK, PK/PD, PBPK, and QSP modeling concepts
- Author/review/approve clinical protocols, analysis plans, study reports, and regulatory submissions
- Provide clinical pharmacology expertise and oversight during clinical study execution
- Organize and interpret data, and present analyses to key internal (development teams, senior management) and external stakeholders (advisory boards, scientific meeting abstracts, posters, and manuscripts)
- Recruit, supervise, develop, and mentor junior level scientists
- Develop and maintain collaborative working relationships with colleagues within and outside the department
- Maintain scientific awareness regarding advances in indications of interest, regulatory awareness regarding new guidance and rules, and industry awareness regarding trends and competition through literature, conferences and stakeholder interactions
- Ph.D., Pharm.D., M.D. or equivalent advanced degree in related discipline
- Minimum of 10 years of industry experience with both small and large molecules, as well as knowledge of human immune system for development of immuno-oncology drugs
- Must have a demonstrated ability to critically analyze problems and provide innovative solutions along with strong leadership skills
- Demonstrated expertise managing/developing staff and building infrastructure with department processes, systems and Standard Operating Procedures (SOPs).
- Thorough knowledge of current and emerging scientific standards and regulatory requirements for global territories
- Proven track record of extensive experience in the design, coordination and implementation of clinical studies
- In depth knowledge contemporary PK, population PK, QSP modeling concepts, data analysis, and interpretation; demonstrated record in applying these concepts to support clinical development programs; desire and curiosity to acquire scientific knowledge for portfolio projects
- Flexible, results oriented and demonstrated ability to work in a fast-paced, timeline-driven environment
- Excellent written and verbal communication skills and ability to convey complex technical information clearly
- Previous experience in biologics and small molecules, as well as knowledge of human immune system for development of immuno-oncology drugs
- Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, PowerPoint