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.
In this individual contributor role (title TBD based on experience), the successful candidate will be responsible for outsourcing and monitoring nonclinical studies to support the advancement of DICE molecules throughout the drug development continuum. Strong organizational skills, clear and effective communication, and the ability to balance many competing priorities is critical. This position requires adaptability to work both independently and in collaboration with internal/external stakeholders in a fast-paced environment. They will work closely with functions including but not limited to Toxicology, DMPK, CMC, Quality, Regulatory and Finance, and will report to the Director of Nonclinical Operations.
- Maintains and strengthens relationships with nonclinical vendors / Contract Research Organization (CRO) partners
- Stays informed of current CRO lead times and contributes to forecasting of studies to effectively support DICE’s portfolio
- Responsible for advising project teams on strategic CRO selection and outsourcing of new studies
- Contributes to the tracking of CRO performance metrics to inform and influence DICE’s outsourcing strategy
- May require occasional travel for CRO/test site qualification and study monitoring (approximately 10%)
- Serves as Sponsor representative on outsourced nonclinical studies (non-GLP and GLP), including safety pharmacology, toxicology, and pharmacokinetic studies
- Directs the cross-functional review of study designs, protocols/amendments, reports, and other study-related documents
- Facilitates timely communication between CRO representatives and DICE scientists to ensure effective and successful execution of studies in compliance with SOPs, protocols, and regulatory guidelines, as applicable
- Tracks material supply and demand in coordination with CMC and toxicologist
- Manages the study timeline and key deliverables in coordination with project manager and team
- May present operational updates at project team meetings and to senior management
- May assist in data analysis and contribute to authoring of regulatory documents
Preferred Experience and Education:
- Bachelor’s degree in a scientific field
- 3-5 years (Manager) or 5-7 years (Senior Manager) in biotech/pharmaceutical industry, preferably with experience in toxicology, pharmacology, pharmacokinetics, immunology, or related discipline.
- Relevant knowledge/experience of in vivo study conduct and/or CRO study monitoring experience is highly desirable
- Detail oriented with strong computer and organizational skills
- Excellent verbal and written communication with exceptional interpersonal skills
- Knowledge of common toxicology study procedures, GLP regulations, animal welfare standards, and SEND requirements
- Understanding of the drug development process and cross-functional roles/responsibilities
- Demonstrated ability to multi-task, prioritize, anticipate challenges, problem solve and achieve high quality outcomes
- Capable of thriving in a fast-paced culture; start-up experience is a plus
- Proactive, energetic, self-assured professional with high personal integrity
- Treats people with respect, inspires the trust of others and contributes to a positive team spirit
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.