Crescent Biopharma · 9 hours ago
Director, Clinical Pharmacology
United States
Full-time
Remote
Director/Executive
$226K/yr - $250K/yr
8+ years expCrescent Biopharma is focused on building a leading oncology company with innovative therapies for cancer patients. The Director, Clinical Pharmacology will develop and implement clinical pharmacology strategies and collaborate with cross-functional teams to support research and development programs.
BiotechnologyHealth CareMedical Device
Responsibilities
Serve as the lead clinical pharmacologist on the project team, accountable for clinical pharmacology deliverables, providing subject matter expertise on PK/PD and quantitative pharmacology
Play a pivotal role in planning and executing clinical pharmacology activities to support development programs
Drive utilization of model-based drug development approach for human PK prediction, dose and dosing regimen selection and optimization, collaborating closely with cross functional colleagues
Oversee and/or perform PK/PD data analyses and contribute to the interpretation of study results through all phases of clinical development
Lead preparation and review of clinical pharmacology sections of study protocols, reports, investigators' brochures and regulatory filings (IND’s, BLA’s, etc.), and respond to regulatory inquiries related to clinical pharmacology
Provide oversight to vendors and consultants to ensure timely delivery of high-quality data and reports to support go/no-go decisions and dosing strategy
Assure the implementation and adherence to SOPs, GXPs, and regulatory standards in clinical pharmacology programs
Qualification
Required
PhD in pharmaceutical sciences, pharmacology with a focus on pharmacokinetics and pharmacometrics
Strong understanding of clinical pharmacology study design, data analysis, and regulatory requirements
Minimum 8 years of experience in clinical pharmacology and pharmacometrics, with hands-on experience in PK data analysis
Preferred
Prior experience in the field of ADC development is a plus
Experience in the Oncology therapeutic area is highly desirable
Benefits
100% employer-paid benefits package.
Flexible PTO.
Two, one-week company-wide shutdowns each year.
Medical, dental, vision, life insurance, short- and long-term disability.
401(k)
Vacation – Unlimited PTO
Sick time – 10 days per calendar year
Holiday pay, including two Company shut downs
Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child
FMLA
Military Leave
Company
Crescent Biopharma
Crescent Biopharma is a biotechnology firm focused on developing novel precision-engineered medicines.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$585MKey Investors
Fairmount Funds Management
2025-12-04Post Ipo Equity· $185M
2025-06-16Post Ipo Equity· $200M
2025-06-16IPO
Recent News
2026-01-06
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