LONGBOARD LIFE

Job Title: Director, ADME
Reports To: V.P., Nonclinical Development
Department: R&D Nonclinical Development
Depart Code: 4105
People Manager: No
FSLA Status: Exempt
Location: Remote or La Jolla, CA

Summary

The Director of ADME will design, oversee, manage, and interpret nonclinical in vitro and in vivo ADME studies to support the development of compounds in Longboard’s development pipeline. The Director of ADME will possess deep knowledge and expertise in metabolism and pharmacokinetics with the ability to identify and follow up on issues that may present a hurdle to clinical development and/or affect human safety. The incumbent will play a pivotal role on cross-functional teams, and author and edit regulatory documents.

Responsibilities

• Hands-on study design, study management, data analysis, and presentation for nonclinical studies are required to support development activities.
• Represent ADME as the subject matter expert for nonclinical development.
• Support programs at different stages with in vitro metabolism and in vivo ADME studies to ensure a complete understanding of the metabolism, tissue uptake/distribution, excretion profiles of drug candidates across species, and potential drug-drug interactions.
• Conceive of and develop strategic plans for metabolite identification and characterization.
• Deliver the preclinical and translational DMPK work package to support projects in lead optimization and clinical candidate selection.
• Perform human PK projection and contribute to the analysis of preclinical PK/PD data for the selection of FIH dose levels.
• Lead and prepare DMPK components of preclinical and clinical study protocol designs, nonclinical and clinical study reports, and investigator brochures.
• Collaborate with Clinical Development to characterize human pharmacokinetics, metabolism, and biopharmaceutics of clinical compounds.
• Partner with other departments as needed to advance drug development.
• Author and edit key pre-clinical and regulatory documents including study protocols and reports, investigator brochures, IND/IMPDs, CTAs and NDAs within agreed timelines.
• Monitor timelines, objectives, and budgets.
• Ensure rapid and effective communication of high-quality data and results to project teams.
• Manage junior team members.
• Other duties as assigned.

Qualifications

• Ph.D. in Chemistry, Pharmacology, Pharmacy, or related field required.
• 10+ years of industry experience with particular experience in regulated drug development.
• Small molecule drug development experience across multiple therapeutic areas including central nervous system disorders is strongly preferred.
• Strong knowledge of ADME concepts, pharmacokinetic modeling, and pharmacodynamic and bioanalytical principles.
• Deep expertise in metabolism, metabolic pathway identification, and knowledge of regulatory guidance and work streams related to metabolite characterization.
• Strong strategic understanding of the appropriate timing of studies and data needed to enable relevant stage of clinical development.
• Working knowledge of pharmacokinetic and other analysis software (e.g., WinNonlin, NONMEM, etc.) and demonstrated ability to plan, organize, and critically assess and/or perform PK/PD data analysis.
• Expertise in developing, validating, and troubleshooting bioanalytical methods for various matrices.
• Experience working with multiple national and international CROs.
• Experience in authoring regulatory submissions and preparing detailed science-based responses to regulatory questions.
• Working knowledge of CMC and product quality, to enable impurity assessment and justification of specifications.
• Ability to manage multiple work streams and projects concurrently.
• Ability to problem-solve, research issues, and propose solutions.
• Excellent interpersonal and communication skills, both written and oral, and the ability to communicate complex information succinctly.
• Effective and constructive collaborator.
• Ability to function independently in a fast-paced, virtual environment.
• Strong working knowledge of GxP, FDA, and ex-US regulatory requirements for the conduct of nonclinical safety studies to support regulatory filings.

“Pay Transparency”

The salary range for candidates who work in La, Jolla, CA is $197-243k. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.

“Benefits”

Employees (and their families) are eligible for medical, dental, vision, and basic life insurance. Employees can enroll in our company’s 401k plan which currently includes matching up to 4% of earnings to IRS limits. Employees are also eligible for unlimited paid time off. Employees also currently enjoy paid time off for federal holidays and company closures for a week in August and a week in December each year. Benefits are subject to change.

“Other compensation”

Hired applicants will be granted stock options and may be eligible for annual bonuses.

TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:

Director, ADME – Longboard Pharmaceuticals, Inc. – Career Page (applytojob.com)