Formation Bio is hiring a
Senior Director Clinical Pharmacology

Summary

Formation Bio is seeking an experienced Senior Director of Clinical Pharmacology to lead clinical pharmacology efforts in their drug development platform, with a focus on late-stage programs across multiple therapeutic areas. The role requires a PhD or PharmD in Clinical Pharmacology or a related field with at least 15 years of experience in the biopharmaceutical industry, and a minimum of 10 years in a supervisory role.

Requirements

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

Responsibilities

• Develop clinical pharmacology strategy consistent with the target product profile, program goals and regulatory strategy
• In collaboration with the Clinical Development team, define biopharmaceutics and clinical pharmacology studies needed to support NDA and drug label
• 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
• Manage resources, timelines, and budget for clinical pharmacology activities
• Mentor and develop the clinical pharmacology team, fostering a culture of scientific excellence and innovation
• Represent Formation Bio's clinical pharmacology capabilities at scientific conferences and partner meetings
• Prepare Clinical Pharmacology Section of regulatory documents, including INDs, NDAs, and briefing documents

Benefits

• Competitive compensation relative to the New York City market, regardless of location
• Equity
• Generous perks
• Location flexibility
• Comprehensive benefits