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Crescent Biopharma · 8 hours ago

Director, Clinical Pharmacology

Waltham, MA

Full-time

Onsite

Director/Executive

$226K/yr - $250K/yr

8+ years exp

Crescent Biopharma is focused on developing transformative therapies for cancer patients. The Director, Clinical Pharmacology will lead the clinical pharmacology efforts, providing expertise and oversight in pharmacokinetics and regulatory submissions to support the company's 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

Clinical pharmacologyPharmacokineticsPharmacometricsData analysisOncology experienceRegulatory filingsVendor oversightCross-functional collaboration

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.

Access to resources, mentorship, and growth opportunities.

Medical, dental, vision, life insurance, short- and long-term disability.

Company’s savings plan (401(k)).

Company’s long-term incentive program.

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.