The Senior Director Clinical Pharmacology will provide leadership and implementation of the clinical pharmacology and pharmacokinetics strategies and initiatives across our early and late-stage clinical programs. The successful candidate is highly motivated with deep knowledge in clinical pharmacology and quantitative sciences applied to large and small molecules. The candidate will represent the function on program and strategy teams and work closely with scientists and other development functions to implement stage-appropriate development plans that will lead to clinical programs and protocols acceptable to global regulatory authorities. The candidate will be responsible for recruiting and managing top clinical pharmacology talent. Our experienced group emphasizes a collegial, collaborative, innovative, and fun environment.

In this role you will:
• 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

Requirements:
• 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

SALARY RANGE

$269,000.00-$300,600.00