At DICE Therapeutics, 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.
Position Summary:
In this individual contributor role (Senior/Principal/Staff title TBD based on experience), the scientifically minded toxicologist will have considerable experience with small molecules across discovery to clinical development stages. The successful candidate will play a leading role at DICE, providing both strategic and hands-on support to our small molecule immunology drug development pipeline. He/she will work both independently and in collaboration with multidisciplinary project teams in a fast-paced environment, and will report to the Senior Director of Toxicology.
Key Responsibilities
o Serve as toxicology lead/project representative on cross-functional teams spanning discovery through clinical stages
o Design stage-appropriate testing strategies, including nonGLP and GLP in vitro and in vivo toxicology and safety pharmacology studies
o Independently analyze complex datasets, consider alternatives and gaps, and make recommendations for next steps
o Effectively present and lead discussions at project teams and with senior management
o Review/prepare study protocols and reports in collaboration with Nonclinical Ops and other key team members
o Lead authoring of regulatory submissions, including CTAs, INDs, DSURs, Briefing Documents, and NDAs
o Represent DICE in meetings and other communications with external partners and Health Authorities
o Build and maintain strong and collaborative relationships with cross-functional team members
o Actively contribute drug development expertise in team discussions
o Stay informed on new regulatory guidance’s and important literature relevant to project safety/risk assessments
o Ensure high scientific and ethical standards
Preferred Experience and Education:
o PhD or equivalent in toxicology or related scientific discipline
o Minimum of 8 years relevant experience as a toxicologist in biotech/pharmaceutical industry
o Extensive experience with small molecule drug development issues
o Strong familiarity with GLP regulations, and relevant ICH and FDA guidance documents
o Ample knowledge/experience working with Nonclinical Ops and CROs on toxicology and safety pharmacology studies
o Detail oriented with strong computer and organizational skills
o Excellent verbal and written communication with exceptional interpersonal skills
o Demonstrated ability to multi-task, prioritize, anticipate challenges, problem solve and achieve high quality outcomes
o Capable of thriving in a fast-paced culture; start-up experience is a plus
o Proactive, energetic, self-assured professional with high personal integrity
o Treats people with respect, inspires the trust of others and contributes to a positive team spirit
DISCLAIMER
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