Position Title: Non-Clinical Director of Pharmacokinetics (PK) and Absorption, Distribution, Metabolism, and Excretion (ADME)
Location: Burlingame, CA
Position Overview:
We are seeking a highly motivated and experienced Non-Clinical Director of PK/ADME with a strong background in oncology and immunology therapeutics. In this role, you will lead the design, execution and interpretation of preclinical studies to evaluate the pharmacokinetics (PK) and ADME properties of novel therapeutic candidates. You will play a critical role in guiding drug discovery and development teams to ensure successful transition of candidates from preclinical to clinical phases.
Key Responsibilities:
Leadership and Strategy:
- Lead the design, implementation, and interpretation of preclinical PK/ADME studies in support of oncology and immunology therapeutic programs.
- Develop and execute PK/ADME strategies to evaluate the drug-like properties of small molecules, biologics, and new modalities.
- Collaborate with cross-functional teams (including pharmacology, toxicology, medicinal chemistry, and clinical development) to integrate PK/ADME data into decision-making.
- Provide scientific and technical expertise in the selection and optimization of lead candidates based on PK/ADME profiles.
Study Oversight and Execution:
- Design, manage, and analyze in vitro and in vivo studies, including ADME, bioavailability, tissue distribution, metabolic stability, and drug-drug interaction studies.
- Oversee outsourced studies with contract research organizations (CROs) and ensure adherence to timelines, budgets, and quality standards.
- Contribute to dose selection and prediction of human pharmacokinetics by leveraging preclinical data.
Data Analysis and Reporting:
- Interpret PK/ADME data and provide insights into the pharmacological activity, safety, and efficacy of drug candidates.
- Communicate scientific findings effectively through written reports, regulatory documents, and presentations to internal teams and external stakeholders.
- Lead the preparation of regulatory submissions (IND, CTA) and ensure PK/ADME components meet regulatory requirements.
Collaboration and Innovation:
- Work closely with the medicinal chemistry and biology teams to optimize lead candidates' ADME properties during early drug discovery.
- Identify and implement novel methodologies, technologies, and modeling approaches to enhance PK/ADME predictions and understanding.
- Act as a scientific mentor to junior scientists and provide guidance on PK/ADME principles and best practices.
Qualifications:
- PhD or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Drug Metabolism, or a related field.
- 10+ years of experience in non-clinical PK/ADME, with a significant portion in cancer and immunology therapeutics.
- Deep understanding of PK/ADME principles and hands-on experience with in vitro and in vivo models.
- Demonstrated expertise in drug development from lead optimization through preclinical and clinical phases.
- Experience working with biologics and small molecules in oncology or immunology.
- Familiarity with regulatory requirements and guidelines (FDA, EMA) for PK/ADME data submission.
- Strong leadership, project management, and team collaboration skills.
- Excellent written and verbal communication skills, with the ability to convey complex scientific concepts to diverse audiences.
Preferred Skills:
- Experience with computational modeling, PBPK (physiologically based pharmacokinetic modeling), or translational sciences.
- Strong network of collaborators in academia, CROs, and regulatory agencies.
This position offers the opportunity to drive the success of a cutting-edge therapeutic pipeline, helping to bring novel treatments to patients with cancer and immune-related disorders. If you are passionate about drug development and PK/ADME science, we encourage you to apply.
This position is located in Burlingame, CA. We are not considering remote applicants.
The salary range for this position is $175,000 - $250,000 USD annually. This salary range is an estimate; the actual salary may vary based on the Company’s compensation practices.
Corvus is an equal-opportunity employer.
