Director, Clinical Pharmacology

Job Description

Job DescriptionAbout UsCrescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X. Position OverviewThe Director, Clinical Pharmacology will be responsible for developing and implementing clinical pharmacology and modeling & simulation strategies to support Crescent’s 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 (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.
• Two, one-week company-wide shutdowns each year.
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities.

The anticipated base pay range for this position is :$226,000 to $250,000 USD.Additional Description for Pay Transparency: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 Company’s savings plan (401(k)). This position is eligible to participate in the Company’s 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 through the link below. https://www.crescentbiopharma.com/careers/#benefits E-Verify:Crescent Biopharma, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires. __Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.