2 Senior Director Clinical Pharmacology

## About the Position Formation Bio is seeking an experienced and innovative 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