Generate:Biomedicines · 1 month ago
Senior Director, Clinical Pharmacology
United States
Full-time
Remote
Director/Executive
$238K/yr - $300K/yr
10+ years expGenerate:Biomedicines is a therapeutics company pioneering Generative Biology™ to create breakthrough medicines. The Senior Director of Clinical Pharmacology will lead strategy and execution for global Phase 2/3 studies, focusing on respiratory indications and global regulatory alignment.
Artificial Intelligence (AI)BiotechnologyHealth CareMedicalProduct Research
Hiring Manager
Rayelle Theeck SHRM-SCP
Responsibilities
Act as the subject matter expert for regulatory agency interactions on clinical pharmacology topics, including INDs, BLAs, and pediatric plans
Design and oversee modeling and simulation efforts to support decision-making and regulatory submissions
Lead the development of global PK, PK/PD, exposure-response related strategies, ensuring alignment with expectations in key regions including the US, EU, China, and Japan
Collaborate closely with Clinical Development, Biostatistics, Regulatory, and Translational Sciences to optimize clinical trial design and endpoints
Drive pediatric strategy including iPSP/PSP development and regulatory engagement
Guide bioanalytical strategy and ensure data integrity across internal and outsourced activities
Provide clinical pharmacology oversight across development stages
Build and lead a high-performing clinical pharmacology function with strong cross-functional influence
Mentor and develop scientists, fostering scientific excellence, accountability, and collaborative innovation
Champion transparency, adaptability, and urgency to meet program and regulatory milestones
Qualification
Required
10+ years of experience in clinical pharmacology within biotech or pharma, including late-stage development and global regulatory interactions
Proven track record leading clinical pharmacology deliverables in regulatory agency engagements, including FDA, EMA, PMDA, and NMPA
Strong background in pediatric development and regulatory submission planning
Deep expertise in PK/PD modeling and simulation, with demonstrated impact on program strategy
Excellent written and verbal communication skills, including authoring and defending regulatory documents
PhD, PharmD, or MD in clinical pharmacology, pharmaceutical sciences, or related field
Preferred
Experience supporting respiratory indications preferred
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