Duality Biologics · 1 month ago
Associate Director，Clinical Pharmacology
United States
Full-time
Remote
Mid, Senior Level, Lead/Staff
2+ years expDuality Biologics is seeking a strategic and results-driven Clinical Pharmacology Lead to serve as a key CP program leader. This role involves providing clinical pharmacology expertise, planning and overseeing studies, and ensuring alignment with overall development plans to inform key decisions.
BiopharmaBiotechnologyHealth CareMedical
Hiring Manager
Susie Sun
Responsibilities
Provide clinical Pharmacology expertise to the projects, plan and works on assigned clinical pharmacology studies to support the overall development plan
Plans, Designs and oversees clinical pharmacology studies as required with operational assistance from Clinical Operation Team
With the study team, tracks emerging clinical pharmacology aspects of the compound, and keeps ensure functional alignment of the compound with the entire DB portfolio
Coordinates with data management, statistician, medical lead, medical writers (and other functional team members) in the data review, analysis and reporting of clinical pharmacology studies
Serve as educator for the clinical study team regarding the specifics of clinical pharmacology knowledge, and its impact on clinical development of the compound (small and large molecules)
Lead the non-compartmental analysis of pharmacokinetic (PK) data and ensure appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, PBPK, concentration-QT etc. Using tools such as NONMEM and R. Direct the planning of all relevant PK-PD analysis
Provides recommendations for clinical doses, dose optimization and dosing adjustment (including drug interaction advice, advice for concomitant administration with food, special population such as renal and hepatic impaired patients, development of new formulations, etc.) to the clinical team and development team and in regulatory documentation such as labelling
Supports clinical pharmacology contributions to all regulatory documents authoring including Investigator’s Brochures, protocol CTA, briefing documents for HA meetings and NDA/BLA dossier (2.7.2.2.7.1)
Qualification
Required
Ph.D., Pharm.D., or M.D. in Clinical Pharmacology, Pharmacometrics, Pharmacy, or a related field
Minimum of 2+ years of industry experience in clinical pharmacology, with a proven track record of successfully leading the clinical pharmacology components of drug development programs
Demonstrated project and program management skills: Experience managing complex timelines, cross-functional dependencies, and budgets
Strong leadership presence: Ability to lead without direct authority, influence senior stakeholders, and drive cross-functional team alignment
Expertise in pharmacokinetics, pharmacodynamics, and model-informed drug development (MIDD) using tools like NONMEM and R
Excellent communication skills, with the ability to communicate scientific concepts into clear strategies and recommendations for diverse audiences including internal cross functional team, external BD partners and regulatory agencies including FDA, CDE and EMA
Company
Duality Biologics
Duality Biologics is a company focusing on the discovery, development and commercialization of new modality biologics to provide solutions.
201-500 employees
H1B Sponsorship
Duality Biologics 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 (3)
2024 (2)
2023 (3)
Funding
Current Stage
Public CompanyTotal Funding
$90MKey Investors
Lilly Asia Ventures
2025-04-15IPO
2021-05-19Series B· $90M
Leadership Team
John Zhu
Founder&CEO
Recent News
2025-09-12
2025-09-12
Company data provided by crunchbase