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 multifaceted role, you will be a key cross-functional contributor to Clinical Operations, Development Sciences and Quality Assurance and will be responsible for driving non-clinical and clinical operational success across DiCE's Clinical Development portfolio. You will be responsible to assure adherence to GxP in conduct of DiCE studies, with your primary objectives being the quality and integrity of generated data, and the rights and welfare of participants /patients. You must have a positive, proactive, creative mindset and be open to navigating the ambiguity of a start-up environment. Proven leadership and the ability to work in a fast-paced environment are essential for this position. This position reports to the Senior Director, Clinical Operations.
· Develops /implements departmental processes for the conduct and oversight of clinical and non-clinical trials and vendors; may develop study operational plans and contribute to study management efforts, as needed
· Establishes, tracks, analyzes, and reports on cross-program operational metrics to influence DiCE strategy; assists with the development of new tracking tools and processes
· Monitors, measures, and reports on cross-program operational issues, opportunities, and development plans and achievements
· Participates in the review of clinical /non-clinical data
· Leads effort to define, implement, and manage external partner /vendor strategies, incl. clinical /non-clinical study planning, vendor evaluation/selection, contract execution, vendor oversight
· Develops and maintains intelligence on key external partners, including clinical and non-clinical CROs, clinical /analytical labs, clinical trial ancillary service providers (IRT, Supply Chain, ePRO, TMF, etc.) and others as required
· Independently leads the RFI and RFP/vendor selection process including preparing RFPs, and reviewing proposal responses and conducting complex budget analysis and comparisons
· May serve as a single point of contact between scientific functions (Clinical Pharmacology, Toxicology, DMPK, etc.), external partners, and study teams to operationalize logistics, ensure successful analysis, and facilitate timely delivery of data to internal stakeholders
· Compiles and maintain regular portfolio-level vendor status reports of timelines, progress and risks, presenting routine updates to study teams and Clinical Development leadership
· Tracks outside spend /budget planning and management of actual spend (invoices, PO)for studies; identifies opportunities to reduce costs, increase efficiency, and mitigate risk related to outsourced services across the portfolio
Quality Assurance (CQA):
· Partners with CQA to ensure Clinical Development vendor selection processes are efficient and compliant with ICH GCP E6, and oversees vendor risk mitigation per ICH GCP E6 guidelines
· Liaises with CQA to establish mechanisms for external partner quality /risk management oversight and improvement related to Clinical Development activities, tracks and monitors vendor deviations and related follow-up
· Ensures that study data and documentation received from all external partners meets FDA/GCP/ICH regulations, and that studies are carried out according to the study protocol, SOPs, study-specific manuals and procedures, as well as DiCE quality standards
· Fully understands the need for and importance of being inspection-ready and diligently follows all DiCE SOPs; identifies and communicates if there are gaps, contributes to new SOPs
· Develops, mentors, and inspires junior colleagues; participates in hiring activities, etc.
· Expands knowledge of operational and scientific principles under some direction and guidance of senior staff but largely self-directed (works independently but knows when to involve others)
· Actively participates /leads departmental meetings, initiatives or forums; proactively contributes ideas to enhance the efficiency and effectiveness of Clinical Development
· Builds best practices in operational methodologies, systems and processes, and/or knowledge management with particular emphasis on quality and cycle time
· Completes a variety of other responsibilities as assigned and agreed upon with direct manager
Preferred Experience and Education:
· Bachelor’s degree in scientific field, or equivalent training and relevant experience.
· Minimum of 10 years of experience in biotech/pharma/clinical research industry with at least 5 years of direct experience in clinical operations, business management and/ or outsourcing role (Sponsor experience required) and 5 years direct oversight of clinical and/or non-clinical databases/systems, and lab /specimen management experience.
· Early Development experience required. Start-up experience a plus.
· Expertise in outsourcing and contracting best practices for all phases of research and development with an in-depth understanding of the drug development process and the cross-functional responsibilities including pre-clinical, clinical trial design, study start-up and execution, monitoring and site management, safety reporting, data management and biometrics. Experience in immune-mediated inflammatory diseases is a plus.
· In-depth experience soliciting and critically evaluating service provider proposals, negotiating contractual terms, and growing and fostering long-term, healthy vendor /site relationships. Experience contracting with and managing preclinical vendors is a plus.
· Extensive knowledge of Good Clinical Practices (FDA and ICH), a solid understanding of 21 CFR Part 11, 50, 54, 56& 312 with respect to clinical systems, including database, eCRF validation procedures, Quality Assurance, eTMF requirements and ICH E-6(R1 & R2)
· Proven ability to manage multiple projects while maintaining quality.
· Ability to think strategically and objectively and with creativity and innovation.
· Treats people with respect; works with integrity /ethics; upholds DiCE organizational values.
· Is a true team player; gives and welcomes feedback; contributes to building a positive team spirit; supports other's efforts to succeed.
· Strong computer skills required including MS Office (Word, PowerPoint, MS Project), including a high-level proficiency/expertise in Excel.
· Position is based in South San Francisco, with potential for flexible work arrangements.
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