Senior Director, Clinical Pharmacology

About This Role

Lead clinical pharmacology efforts by developing strategic plans, designing and overseeing studies, and providing scientific leadership for late-stage drug development programs across multiple therapeutic areas. This role plays a crucial part in accelerating the delivery of new treatments to patients through an innovative, tech-enabled drug development platform.

Responsibilities

• Develop clinical pharmacology strategy consistent with the target product profile, program goals, and regulatory strategy
• Define biopharmaceutics and clinical pharmacology studies needed to support NDA and drug label in collaboration with Clinical Development team
• Lead clinical pharmacology activities in supporting late-stage drug development programs across multiple therapeutic areas
• Design and oversee the execution of clinical pharmacology studies to support clinical development and regulatory submissions
• Determine scope, design, plan and analyze Phase 1-IV PK and PD studies, including development of appropriate population PK models
• Contribute clinical pharmacology expertise to due diligence efforts for potential in-licensing opportunities
• Serve as the primary Clin Pharm lead and effectively participate in cross-functional teams to ensure integration of modern clinical pharmacology principles into project plan and study design
• Provide scientific leadership in interactions with regulatory agencies and external partners
• Develop and implement innovative approaches to enhance the efficiency and effectiveness of clinical pharmacology studies
• Prepare Clinical Pharmacology Section of regulatory documents, including INDs, NDAs, and briefing documents

Requirements

• PhD or PharmD in Clinical Pharmacology or a related field
• 15+ years of experience in the biopharmaceutical industry
• 10+ years in a supervisory role in conduct and/or oversight of clinical pharmacology
• Proven track record in leading clinical pharmacology efforts in late-stage drug development
• Strong understanding of regulatory requirements for clinical pharmacology studies
• Competent in the use of PK and PK/PD modeling software tools
• Experience in due diligence activities for in-licensing opportunities
• Excellent communication and leadership skills

Qualifications

• PhD or PharmD in Clinical Pharmacology or a related field
• At least 15 years of experience in the biopharmaceutical industry, and a minimum of 10 years in a supervisory role in conduct and/or oversight of clinical pharmacology

Nice to Have

• Innovative mindset and enthusiasm for leveraging technology in drug development

Skills

* Required skills

Benefits