Company Overview:
Join a leading biotechnology company dedicated to the discovery and development of innovative therapies for cancer and other serious diseases. We are seeking a highly motivated Clinical Pharmacology Lead to help advance our portfolio of small molecules and biologics through all stages of drug development. This role will be critical in shaping the pharmacology strategies that drive our programs from early research to post-marketing.
Responsibilities
- Design and execute clinical pharmacology and pharmacometric plans to guide programs through all phases, from early research to post-market stages.
- Act as the lead for clinical pharmacology within project teams, offering expertise in areas such as PK/PD, biopharmaceutics, drug-drug interactions, and quantitative pharmacology.
- Advance small molecules and biologics through key development checkpoints, including regulatory submissions like IND/CTA, EOP2, and marketing approvals.
- Lead and/or perform PK/PD and exposure-response evaluations utilizing advanced modeling and simulation tools to inform human pharmacokinetics, dose optimization, trial design, risk/benefit assessments, decision points, regulatory documentation, and scientific publications.
- Collaborate closely with various departments, including Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations, and Regulatory teams, to achieve project and organizational goals.
- Increase external scientific presence and meet publication targets.
- Engage with internal and external experts to assess and incorporate the latest methodologies, models, and tools to ensure cutting-edge capabilities.
- Ensure adherence to SHE policies, GXP standards, and regulatory guidelines within clinical pharmacology initiatives.
Benefits:
Full-time employees become eligible for benefits on the first of the month following 30 days of continuous service. These benefits include:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Employer-Paid Basic Life Insurance
- Supplemental Life Insurance
- Employer-Paid Short-Term Disability
- Long-Term Disability
- 401(k) Plan
- Paid Time Off
- Paid Holidays
