Director/Senior Director, Clinical Pharmacology

About the Position 

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 modalities 
• 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 ADME characterization, dose selection and optimization, drug-drug interaction (DDI) studies, special population analyses (renal/hepatic impairment, pediatrics, elderly), and development of appropriate population PK (PopPK) models using tools such as NONMEM and Monolix
• Apply physiologically-based pharmacokinetic (PBPK) modeling to support dose predictions, DDI risk assessment, and labeling decisions across patient populations
• 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 sections of regulatory documents, including INDs, NDAs/BLAs, and FDA/EMA briefing documents; lead exposure-response (E-R) analyses in support of labeling; and respond to agency questions on PK/PD

About You 

• 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
• Proficiency in PK and PK/PD modeling software, including NONMEM, Monolix, or similar population PK tools; experience with PBPK platforms (e.g., Simcyp, GastroPlus) is a plus
• 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: $311,000 - $388,500