About the Positionย
Formation Bio is seeking an experienced and innovative Director/Senior Director of Clinical Pharmacology to join our Development team. In this role, you will lead our clinical pharmacology efforts, supporting early-stage drug development and contributing to business development activities across multiple modalities. You will play a crucial role in advancing our mission to bring new treatments to patients faster and more efficiently through our innovative, tech-enabled drug development platform.
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 translational and early-stage drug development programs across multiple therapeutic areas and modalitiesย
- 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
- 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
About Youย
- PhD or PharmD in Clinical Pharmacology or a related field with at least 10 years of experience in the biopharmaceutical industry, and a minimum of 5 years in a supervisory role in conduct and/or oversight of clinical pharmacology
- Proven track record in leading clinical pharmacology efforts in early and late-stage drug development
- Strong understanding of regulatory requirements for clinical pharmacology studies in support of clinical development
- 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
- Ability to work effectively in a fast-paced, cross-functional environment
- Innovative mindset and enthusiasm for leveraging technology in drug development
Total Compensation Range:ย $311,000 - $388,500