Director, Clinical Pharmacology
We are seeking a Director, Clinical Pharmacology will be responsible for developing and implementing clinical pharmacology and modeling & simulation strategies to support Crescents research and development programs. The ideal candidate will provide expertise in pharmacokinetics, dose optimization, pharmacometrics, collaborate with cross-functional teams and manage clinical pharmacology activities, data analysis, and global regulatory filings.
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 (INDs, BLAs, 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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Additional Description for Pay Transparency:
The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Companys savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: 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. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits $226,000 - $250,000 a year
Compensation details: 226000-250000 Yearly Salary
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