Director, Clinical Pharmacology

Opportunity

As a key member of the Clinical Pharmacology group, you will:

• Responsible for clinical pipeline delivery through major milestones including IND/CTA, EOP2, and marketing applications
• Lead the design and execution of an integrated clinical pharmacology and modeling and simulation strategy to guide the clinical development plan
• Apply state-of-the-art quantitative pharmacology analyses, including PBPK, translational PK/PD, population PK, exposure-response analyses, and system pharmacology, to guide dose/schedule selection and recommended phase 2 dose and schedule (RP2Ds) selection
• Author and provide technical input for regulatory documents and submissions related to all aspects of clinical pharmacology (including protocol, IB, briefing package, etc) and responses to regulatory questions
• Engage and work with consultants and/or CROs on clinical pharmacology activities to complement in-house knowledge/expertise and capacities
• Represent the clinical pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions
• Ability to manage internship and fellowship programs

Required Skills, Experience and Education

• A Ph.D. or Pharm.D. with 8+ years of relevant industry experience in Clinical and Quantitative pharmacology
• Expertise in clinical pharmacology, hands-on modeling, and simulation skills using NONMEM, R, and/or other modeling and simulation software
• Experience with population PK, exposure-response, and advanced mechanistic PK/PD models
• Track record of applying modeling and simulation methodologies to inform and accelerate drug development
• Well-informed in current and emerging scientific standards of regulatory requirements and expectations
• Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences
• Strong interpersonal skills, and ability to influence development project and management teams
• A critical thinker and passionate team player with high energy who thrives in a dynamic and fast-paced environment

Preferred Skills

• Hand-on experience with PBPK models using SimCYP and PK-sim
• Prior experience with small molecules in oncology drug development
• Prior experience with authoring regulatory documents such as IND/CTA, EOP2, and marketing applications NDA/sNDA

Pay

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $211,000 - $264,000 USD.