Formation Bio

Formation Bio

Senior Director, Clinical Pharmacology

Boston, MA; New York, NY · Director

Sponsorship not specified$311k-$389kDetected 22 days ago
SparkBusiness DevelopmentPharmacologyFDA RegulatoryResearchExperimental DesignLeadershipCommunicationCollaboration

About the role

  • About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.
  • 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.
  • About the Position Formation Bio is seeking an experienced and innovative Senior Director of Clinical Pharmacology to join our Development team.

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
  • 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

Nice to have

  • 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

Compensation

  • Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience.
  • In addition to base salary, we offer equity, comprehensive benefits, and generous perks.
  • $311,000 - $388,500

Benefits

  • Our Vision for AI in Pharma

Company info

  • 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.

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.
  • Equal Opportunity Formation Bio is committed to building a diverse and inclusive team.
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