Director/Sr. Director - DMPK
REMOTE
Competitive Compensation + excellent bonus/benefits
Currently working with a leading Clinical-Stage Biotech focused on developing and delivering next-generation oncology related therapeutics.
They have joint partnerships with a handful of Top 10 Global Pharma companies, backing their innovative approach on modern medicine.
Duties and Responsibilities:
- Able to facilitate, analyze and interpret the critical in vitro/in vivo DMPK data
- Ensure protocols are in compliance with company policies, such as cGMP, USP and FDA regulations
- Act as the department lead in Discovery and Clinical program
- Collaborate and manage in-house and outsourced lab activities(CROs) for ADME, PK, & bioanalytical studies.
- Analyze and interpret in vitro/in vivo DMPK data, provide the project team on risk assessment and issue management, and support of clinical study protocol development for human safety and efficacy trial
Qualifications:
- Experience working among CMC leaders (Drug Discovery, Regulatory, Analytical, Quality,etc.)
- Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs)
- M.S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 5-7 years of industry experience
- SME in ADME, PK and bioanalytical. Experienced in PK/PD modeling or drug transporter is a plus
- Excellent organizational, interpersonal and verbal/written communication skills and ability to perform as an effective, flexible and self-assured team player
