Sr./Director, Toxicology

At DiCE Molecules, we design and develop innovative therapies inimmunology for patients with debilitating disease.

Seeking to create a futurewhere convenient oral medicines with biologic-like efficacy are available to patientswith serious medical conditions, we are developing oral alternatives tomedicines currently limited to injectable forms.

In this role, the (Sr.) Director of Toxicology will: collaborate closely with multidisciplinary R&Dfunctional areas to leadall aspects of nonclinical development includingdesign, execution, management, and regulatory submissions of nonclinicaltoxicology, safety pharmacology, and other critical safety studies in supportof both preclinical and clinical pipelines to enable decision making for the advancementof drug candidates.

This position reports to our VP, Development Sciences, and is based in South San Francisco, with the potential for flexible workarrangements.

Key Responsibilities:

· Designsand oversees nonclinical toxicology programs and strategies to characterize toxicologyprofiles of drug candidates, ensures timely nonclinical study deliverables enablingdecision-making in the advancement of small-molecule immunology therapeuticsfrom the research phase through development programs.

· Serves as subject matter expert on research and developmentproject teams and contributes to development strategies by recommending key invitro and in vivo toxicology studies and proper timing of different safetyassessments.

· Manages the contracts and effectively implements/overseesstudies outsourced to CROs and ensures high-quality study execution to meetprogram timelines.

· Analyzes, interprets, and summarizes nonclinical safety data,presents and contextualizes meaningful findings and recommendations to internalproject teams and senior management.

· Supports regulatory submissions/interactions with in-depthknowledge on subject matter expertise and regulatory requirements/guidelinesrelated to toxicology and nonclinical drug development.

· Develops and implements target de-risking, issue screeningand mitigation and resolution strategies for toxicities observed in vivo.

· Develops and manages the budget ofall toxicology programs supporting both research and development pipelines, managesand develops the nonclinical toxicology team (including consultant(s)) andeffectively prioritizes tasks among different programs.

· Participates in and/or leads forumsand process improvement/system initiatives critical to quality processes and workscollaboratively with the quality group to develop proper SOPs.

Preferred Experienceand Education:

· DMV or Ph.D.

in toxicology, pharmacology, Biology, or relatedscientific discipline with 10-15 years of relevant biotech/pharma drugdiscovery/development experience in a team-facing role; DABT certification isdesirable.

· Demonstratedexpertise in nonclinical safety assessment/toxicity study design evaluating smallmolecule drug candidates, prior experience with targeted immunologytherapeutics highly desirable.

· Has athorough understanding of GLP regulations, familiarity with current toxicologyrelated US and ex-US regulatory guidance documents and standards.

· Experiencein authoring nonclinical safety sections supporting IND/NDA (or internationalequivalent) submissions using CTD format, and experiences in interactions with differentregulatory agencies.

· Experiencein contracting and managing safety studies with reputable CROs

· Strongscientific background and scientific reasoning ability in the proactiveidentification of potential issues with excellent critical thinking and abilityto draw conclusions and make appropriate decisions.

· Abilityto work effectively and collaboratively on cross-functional project teams;demonstrated ability to multi-task, prioritize options, anticipate challenges,and execute on goals as a member of an interdisciplinary team is extremelyimportant.

· Excellentverbal, presentation, and written communication skills.

· Experiencein managerial and leadership roles

· Thrivesin a collaborative team setting and is driven by a desire to be innovative in ahigh energy, small company environment

DISCLAIMER

The above information on thisdescription has been designed to indicate the general nature and level of workperformed by employees within this classification.

It is not designed tocontain or be interpreted as a comprehensive inventory of all duties,responsibilities, and qualifications required of employees assigned to thisjob.