Formation Bio · 11 hours ago
Senior Director, Clinical Pharmacology
New York, NY
Full-time
Hybrid
Director/Executive
$318K/yr - $400K/yr
15+ years expFormation Bio is a tech and AI driven pharma company focused on revolutionizing drug development. They are seeking an experienced Senior Director of Clinical Pharmacology to lead clinical pharmacology efforts, support late-stage drug development, and contribute to business development activities.
Artificial Intelligence (AI)BiotechnologyClinical TrialsHealth CareMedicalPharmaceutical
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 late-stage drug development programs across multiple therapeutic areas
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 development of appropriate population PK models
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
Mentor and develop the clinical pharmacology team, fostering a culture of scientific excellence and innovation
Represent Formation Bio's clinical pharmacology capabilities at scientific conferences and partner meetings
Prepare Clinical Pharmacology Section of regulatory documents, including INDs, NDAs, and briefing documents
Qualification
Required
PhD or PharmD in Clinical Pharmacology or a related field with at least 15 years of experience in the biopharmaceutical industry, and a minimum of 10 years in a supervisory role in conduct and/or oversight of clinical pharmacology
Proven track record in leading clinical pharmacology efforts in late-stage drug development
Strong understanding of regulatory requirements for clinical pharmacology studies in support of clinical development
Competent in the use of PK and PK/PD modeling software tools
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
Benefits
Equity
Comprehensive benefits
Generous perks
Hybrid flexibility
Company
Formation Bio
Formation Bio is a drug development company that strives to provide treatments to patients faster by reimagining clinical trials.
51-200 employees
H1B Sponsorship
Formation Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
Funding
Current Stage
Late StageTotal Funding
$528MKey Investors
Andreessen Horowitz
2024-06-26Series D· $372M
2021-09-30Series C· $156M
2018-10-15Series Unknown
Leadership Team
Benjamine Liu
CEO and Co-Founder
Linhao Zhang
Co-Founder and COO
Recent News
Spark Capital
2026-01-07
BioWorld Financial Watch
2025-12-19
2025-12-16
Company data provided by crunchbase