Non-Clinical Director Of Pharmacokinetics Pk And Adme

2+ years

$175K/yr - $250K/yr

Remote, USA

10 Nov. 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Non-Clinical Director of Pharmacokinetics (PK) and ADME
Location: Burlingame, CA
Salary: $175,000 - $250,000 USD annually

Position Overview

We are seeking an experienced Non-Clinical Director of PK/ADME with expertise in oncology and immunology therapeutics to lead preclinical studies focused on pharmacokinetics (PK) and absorption, distribution, metabolism, and excretion (ADME) properties of novel drug candidates. This leadership role will be instrumental in advancing therapeutic candidates from the preclinical to clinical phases, ensuring successful drug development for cancer and immune-related disorders.

Key Responsibilities

Leadership and Strategy

Lead the design, implementation, and interpretation of preclinical PK/ADME studies to support oncology and immunology programs.
Develop and execute PK/ADME strategies for evaluating the drug-like properties of small molecules, biologics, and emerging modalities.
Collaborate with cross-functional teams (pharmacology, toxicology, medicinal chemistry, and clinical development) to integrate PK/ADME data into strategic decision-making.
Provide scientific expertise in the selection and optimization of drug candidates based on their 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 interactions.
Oversee outsourced studies with CROs, ensuring timely, high-quality results within established budgets.
Contribute to dose selection and prediction of human pharmacokinetics based on preclinical data.

Data Analysis and Reporting

Interpret PK/ADME data and provide insights into pharmacological activity, safety, and efficacy.
Communicate findings clearly in written reports, presentations, and regulatory submissions (IND, CTA).
Ensure PK/ADME data meets regulatory requirements and supports IND/CTA submissions.

Collaboration and Innovation

Work closely with medicinal chemistry and biology teams to optimize lead candidates’ ADME properties.
Implement novel methodologies and technologies to enhance PK/ADME predictions and understanding.
Mentor junior scientists, providing guidance on PK/ADME principles and best practices.

Qualifications

PhD or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Drug Metabolism, or related field.
10+ years of non-clinical PK/ADME experience, with a strong focus on cancer and immunology therapeutics.
Extensive hands-on experience with in vitro and in vivo models in drug development.
Expertise in drug development from lead optimization to preclinical and clinical phases.
Experience with both biologics and small molecules in oncology or immunology.
Familiarity with regulatory guidelines (FDA, EMA) for PK/ADME data submission.
Proven leadership, project management, and cross-functional collaboration skills.
Excellent written and verbal communication skills, with the ability to explain complex scientific concepts to diverse audiences.

Preferred Skills

Expertise in computational modeling, PBPK (physiologically based pharmacokinetic modeling), or translational sciences.
Established network of collaborators in academia, CROs, and regulatory agencies.

Why Apply?

This is an exciting opportunity to play a key role in advancing cutting-edge therapeutic programs in oncology and immunology. If you are passionate about drug development and PK/ADME science, we invite you to apply and contribute to novel treatments that could benefit patients with cancer and immune-related disorders.

Additional Information

Location: Burlingame, CA
Remote work: Not available for this position
Salary Range: $175,000 - $250,000 annually (based on experience and qualifications)

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