Kumquat Biosciences Inc. · 3 months ago
Director, Clinical Pharmacology
San Diego, CA
Full-time
Onsite
Director/Executive
7+ years expKumquat Biosciences Inc. is seeking a Director of Clinical Pharmacology to develop and execute clinical pharmacology strategies for small molecule assets. The role involves characterizing pharmacokinetics properties, dose optimization, and collaborating with various stakeholders to support clinical trials and regulatory filings.
Alternative MedicineBiotechnologyOncologyTherapeutics
Responsibilities
Develop and execute clinical pharmacology and pharmacometrics strategies, including dose and schedule determination and dose optimization, to mitigate risks and support development of small molecule candidates from pre-IND and first-in-human testing through all phases of clinical development
Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical development, biostats, regulatory, nonclinical and research to support and impact development decisions
Responsible for protocol design of clinical pharmacology trials, study planning, review, data analysis / interpretation, and reporting of individual studies implemented to support clinical pharmacology components of project plans
Prepare appropriate documents or sections of clinical protocols, clinical study reports with respect to Clinical Pharmacology studies or data
Author regulatory documents (IND’s, NDA’s, IB’s, etc.) and respond to regulatory inquiries related to PK/PD, and clinical pharmacology
Identify and manage consultants and vendors and monitor work with external vendors to ensure compliance with agreed protocols, quality standards and timelines
Review external data, analysis, interpretation, and reporting of clinical pharmacokinetic and pharmacodynamic data
Ensure that appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program while adhering to timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
Analyze, interpret, summarize and present clinical pharmacology data to project teams, investigators and to senior management
Qualification
Required
A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, or related discipline with at least seven years of industry and/or related post-doctoral experience is required
Strong communication skills with the ability to convey pharmacology data to cross functional teams, senior management and external investigators
Preferred
Prior experience with NDA/BLA/MAA filings is desirable
Prior experience with health authority and authoring responses required
Company
Kumquat Biosciences Inc.
Kumquat Biosciences’ vision is to develop innovative therapies to bring about sustainable and life-changing benefits to cancer patients.
11-50 employees
H1B Sponsorship
Kumquat Biosciences Inc. 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 (2)
2024 (2)
2023 (1)
2022 (2)
2021 (2)
Funding
Current Stage
Early StageTotal Funding
$175.92MKey Investors
Loxo Oncology
2021-07-29Corporate Round· $70M
2021-02-16Undisclosed· $50M
2019-07-02Private Equity· $55.92M
Leadership Team
Pingda Ren
Co-Founder, President & COO
Carin Sandvik
VP of Finance
Recent News
Labiotech.eu
2025-09-12
2025-08-17
Company data provided by crunchbase