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Director, Clinical Pharmacology
Waltham, MA$226K - $250KPosted 6 months ago
Full-timeonsite
Job Description
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.
Education & Experience
- 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.
- Prior experience in the field of ADC development is a plus.
- Experience in the Oncology therapeutic area is highly desirable.
What We Offer
- Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
- Competitive compensation, including base salary, performance bonus, and equity
- 100% employer-paid benefits package
- Flexible PTO; also, two, one-week company-wide shutdowns each year
- A commitment to your professional development, with access to resources, mentorship, and growth opportunities
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$226,000 - $250,000 a year