At DiCE Molecules, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
In this role, the (Sr.) Director of Toxicology will: collaborate closely with multidisciplinary R&D functional areas to lead all aspects of nonclinical development including design, execution, management and regulatory submissions of nonclinical toxicology, safety pharmacology, and other critical safety studies in support of both preclinical and clinical pipelines to enable decision making for the advancement of drug candidates. This position reports to vice president, development sciences, and is based in South San Francisco, with potential for flexible work arrangements.
· Designs and oversees nonclinical toxicology programs and strategies to characterize toxicology profiles of drug candidates, ensures timely nonclinical study deliverables enabling decision-making in the advancement of small molecule immunology therapeutics from research phase through development programs.
· Serves as subject matter expert on research and development project teams and contributes to development strategies by recommending key invitro and in vivo toxicology studies and proper timing of different safety assessments.
· Manages the contracts and effectively implements/oversees studies outsourced to CROs, and ensures high quality study execution to meet program timelines.
· Analyzes, interprets, and summarizes nonclinical safety data, presents and contextualizes meaningful findings and recommendations to internal project teams and senior management.
· Supports regulatory submissions/interactions with in-depth knowledge on subject matter expertise and regulatory requirements/guidelines related to toxicology and nonclinical drug development.
· Develops and implements target de-risking, issue screening and mitigation, and resolution strategies for toxicities observed in vivo.
· Develops and manages the budget of all toxicology programs supporting both research and development pipelines, manages and develops the nonclinical toxicology team (including consultant(s)) and effectively prioritizes tasks among different programs.
· Participates in and/or leads forums and process improvement/system initiatives critical to quality processes and works collaboratively with quality group to develop proper SOPs.
Preferred Experience and Education:
· DMV or PhD in toxicology, pharmacology, Biology, or related scientific discipline with 10-15 years of relevant biotech/pharma drug discovery/development experience in a team-facing role; DABT certification is desirable.
· Demonstrated expertise in nonclinical safety assessment/toxicity study design evaluating small molecule drug candidates, prior experience with targeted immunology therapeutics highly desirable.
· Has a thorough understanding of GLP regulations, familiarity with current toxicology related US and ex-US regulatory guidance documents and standards.
· Experience in authoring nonclinical safety sections supporting IND/NDA (or international equivalent) submissions using CTD format, and experiences in interactions with different regulatory agencies.
· Experience in contracting and managing safety studies with reputable CROs
· Strong scientific background and scientific reasoning ability in the proactive identification of potential issues with excellent critical thinking and ability to draw conclusions and make appropriate decisions.
· Ability to 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 extremely important.
· Excellent verbal, presentation and written communication skills.
· Experience in managerial and leadership roles
· Thrives in a collaborative team setting and is driven by a desire to be innovative in a high energy, small company environment
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.