Director of Preclinical Development & Toxicology

Overview

SRI International’s Bioscience Division is seeking a creative, integrative thinker who is driven to use cutting edge approaches to advance early development, preclinical pharmacology and translational medicine. Reporting to the Bioscience Division President, this individual will provide scientific leadership to develop and execute impactful preclinical pharmacology and toxicology. This role requires experience in preclinical drug development within a pharmaceutical, CRO, and/or government lab environment. The successful candidate will be responsible for providing expertise for nonclinical and clinical development plans across multiple drug classes and indications. Applicants should have a strong track record of scientific and collaborative leadership with proven ability to manage a diverse team and provide strategic leadership for a dynamic portfolio.

We are particularly interested in candidates with expertise in next-generation preclinical drug development technologies.

Research experience in the following areas:

• In vitro systems such as organoids, organ chips, and/or microphysiology systems
• AI/ML platforms for in silico preclinical studies, for example, ADME profile modeling and optimization, toxicity modeling and assessment, virtual animal models, AI driven digital pathology and/or predictive models for safety endpoints for drug safety
• Pharmacology in precision medicine such as pharmacogenetics, biomarkers to guide drug development through integrating bench to patient research, and data-driven mechanism-indication pairing

There are two locations for this role (hybrid, but near one of these two locations):  Menlo Park, CA or Harrisonburg, VA.

Responsibilities

• Manage a diverse team of scientists across all aspects of preclinical drug development
• Serve as a subject matter expert (SME) and group leader with the responsibility of mentoring, developing, and overseeing team members within the function.
• Assure projects are managed for quality, timely completion and within budget
• Ensure compliance with global regulatory nonclinical regulations and guidance
• Author and submit regulatory documents and interact with regulatory agencies as needed
• Guarantee compliance with regulatory requirements and industry standards in clinical pharmacology and translational medicine activities, including the design and execution of clinical trials
• Work closely with government clients and maintain an active portfolio of NIH and DOD contracts
• Work with partners in SRI’s commercial and federal business development to expand SRI’s client base
• Develop scientific strategy for the translational development team within SRI
• Establish a research environment which values innovative approaches. Apply creative theories/concepts leveraging multiple disciplines and state-of-the-science technical expertise principles.
• Develop operational plans and deliverables for team function and ensure plans are integrated with functional strategies. 
• Develop and mentor employees.  Align, motivate, and inspire the team to work in accordance with broader BSD and SRI goals.

Qualifications

• Advanced degree (PhD, DVM, MD) in an area such as Toxicology, Pharmacology, or a similarly relevant field of research, with a minimum of 10 years professional experience post-graduation, in preclinical/clinical drug development
• In-depth knowledge and experience with nonclinical safety / biological evaluation regulations, regulatory guidance and expectations to enable the conduct of human clinical trials and approvals of pharmaceutical and/or medical device products
• In-depth knowledge and experience with regulatory submissions and approvals (e.g., USFDA ANDA and 505(b)(2) Applications)
• Experience with software systems associated with preclinical and clinical research, familiarity with FDA software validation requirements
• Experience working within a GLP/GMP environment
• Proven operational excellence and previous experience in process improvements for output, efficiency, and cost effectiveness
• Experience in leading cross-functional teams
• Established scientific excellence demonstrated by scientific presentation at scientific conferences, published scientific articles in peer review journals, and/or inventor on published patents
• Direct experience interfacing with NIH, BARDA, DOD and other federal funding agencies
• Board Certification in a relevant field (DABT, DACMP, DACLAM, etc.) highly desirable

SRI International is an independent, nonprofit research center that takes the most advanced R&D from the laboratory to the real world. Our translational development team has been a trusted provider of preclinical services for the NIH for over 30 years