Senior Director, Clinical Pharmacology

About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. , has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials.

Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry.

Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. 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 l