Generate:Biomedicines · 1 week ago
Senior Director, Clinical Pharmacology
United States
Full-time
Remote
Director/Executive
$219K/yr - $329K/yr
10+ years expGenerate:Biomedicines is a pioneering therapeutics company at the intersection of machine learning, biological engineering, and medicine. They are seeking a Senior Director of Clinical Pharmacology and Pharmacometrics to lead strategy and execution across key Phase 2 and 3 studies, ensuring high-quality clinical pharmacology deliverables and successful regulatory interactions.
Artificial Intelligence (AI)BiotechnologyHealth CareMedicalProduct Research
Responsibilities
Serve as the clinical pharmacology and pharmacometrics lead on late-stage programs, driving PK/PD and exposure-response strategy from early clinical studies through pivotal trials and submissions
Design and oversee modeling and simulation plans to inform dose selection, trial design, and regulatory filings
Author and review key clinical pharmacology and pharmacometrics sections of INDs, BLAs, and related documents; participate in regulatory interactions as functional expert
Collaborate with cross-functional teams to integrate clinical pharmacology and pharmacometrics principles into clinical study designs, endpoints, and statistical approaches
Contribute to pediatric strategy development and submissions
Support the Head of Clinical Pharmacology in building scalable processes, standards, and systems that enable late-stage and global development
Set clear expectations for scientific rigor, data quality, and accountability
Foster an inclusive, high-performing team culture that emphasizes transparency, adaptability, and collaboration
Develop team members through mentorship, coaching, and stretch opportunities
Partner effectively across functions to ensure timely delivery of critical program milestones
Qualification
Required
10–12+ years of experience in clinical pharmacology and pharmacometrics within biotech or pharma, including significant late-stage (Phase 2/3) and regulatory submission experience
Demonstrated success contributing to regulatory agency interactions (FDA, EMA, PMDA, or NMPA) on clinical pharmacology and pharmacometrics deliverables
Strong background in PK/PD modeling and simulation and demonstrated ability to translate quantitative findings into clinical strategy
Excellent communication skills, with the ability to present complex data to diverse audiences
Proven experience building effective cross-functional partnerships
PhD, PharmD, or MD in clinical pharmacology, pharmaceutical sciences, or related field
Preferred
Experience supporting respiratory or immunology indications
Prior experience in a fast-growing or first-to-market biotech environment
Familiarity with combination products or complex biologics
Working knowledge of bioanalytical methods and data review
Benefits
Annual bonus
Equity compensation
Competitive benefits package
Company
Generate:Biomedicines
Pioneering generative biology to create breakthrough therapeutics.
201-500 employees
H1B Sponsorship
Generate:Biomedicines 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 (7)
2024 (12)
2023 (9)
2022 (3)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$693MKey Investors
Samsung Life Science FundAlumni VenturesFlagship Pioneering
2024-12-18Series Unknown
2023-09-14Series C· $273M
2021-11-18Series B· $370M
Leadership Team
Gevorg Grigoryan
Founding CTO
Recent News
FierceBiotech
2025-10-28
Company data provided by crunchbase