Director, Clinical Pharmacology

Required Experience, Skills, and Education

• A Ph.D. or Pharm.D or equivalence with 7+ 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

• Prior experience with small molecules in oncology drug development.
• Proven successful industry experience in oncology submissions in the US, EU and Asia.

Opportunity

• Represent the clinical pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.
• Responsible for clinical pipeline delivery through major milestones including IND/CTA, EOP2, and marketing applications NDA/sNDA.
• 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 population PK, exposure-response analyses, 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, CSR, IB, briefing package, SCP/SBS, label 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.
• Ability to manage internship and fellowship programs.

Benefits

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. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

About the Role

We are seeking a highly motivated and energetic individual with a relevant scientific background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization. As a key member of the Clinical Pharmacology group, you will:

• Represent the clinical pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.
• Responsible for clinical pipeline delivery through major milestones including IND/CTA, EOP2, and marketing applications NDA/sNDA.
• 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 population PK, exposure-response analyses, 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, CSR, IB, briefing package, SCP/SBS, label 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.
• Ability to manage internship and fellowship programs.