Senior Director, Clinical Pharmacology
About this role
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. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., 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.
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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 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
Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply!
Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate.
Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.
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