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, you will be responsible for supporting vendor selection and management across DiCE's clinical development portfolio by demonstrating an in-depth knowledge of vendor relationship management, outsourcing models, contracting strategies, budget management and clinical trial services and technologies. 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 Director, Vendor and Operations Management.
• Manages the identification and selection process of clinical vendors such as CROs, imaging, data management, IRT, home health, central labs, biostatistics, etc., as directed by Clinical Operations
• Generates Requests for Information (RFI), Requests for Proposals (RFP)and budget grids, maintains supplier intelligence
• Coordinates bid defenses and proposal review meetings and provides analysis to project teams
• Negotiates and maintains clinical development contracts, payment terms and budgets, including vendor CDAs, MSAs, Work Orders and Scope Changes for external clinical service providers, consultant agreements and specialty vendor contracts
• Partners with clinical operations to develop clinical site contracting playbooks, leads development of clinical site budgets and ensures budgets are in line with study protocols
• Ensures quality oversight of vendors by establishing and monitoring key performance /risk indicators with suppliers utilizing Scorecard/Metric activities; and communicates feedback to the supplier, encouraging adaptation on best practices across supplier types and development of continuous process improvements/ maintenance
• Partners with suppliers and internal staff to identify, manage, escalate and resolve issues related to supplier performance;
• Develops effective partnerships with suppliers and internal staff.
• Supports Quarterly Budget Review process for clinical study vendor contracts
• Participates in the preparation and presentation of internal reports to management
• Supports Purchase Order management and contract/account reconciliation
• Support vendor qualification activities /annual audits in collaboration with team members from Quality Assurance (QA) andClinical Operations
· Expands knowledge of clinical trials operations and scientific principles and objectives of DICE’s clinical trials under direction and guidance of senior staff; works independently but knows when to involve /collaborate with others
· Builds best practices in operational methodologies, systems and processes, and knowledge management with particular emphasis on quality ,time standards and expectations
· Assists with the development of new tracking tools and processes
· Openness and flexibility to work across different areas in clinical development as needed; may complete a variety of other clinical trial-related responsibilities as assigned and agreed upon with direct manager
Preferred Experience and Education:
· Bachelor’s degree in scientific field, or equivalent training and experience
· At least 5 years of direct experience in clinical outsourcing role (Sponsor preferred)
· In-depth experience soliciting and critically evaluating service provider proposals, negotiating contractual terms, and growing and fostering long-term, healthy vendor /site relationships
· Expert in outsourcing and contracting best practices for all phases of clinical research with an understanding of the drug development process and the cross-functional responsibilities including clinical trial design, study start-up and execution • In-depth experience soliciting and critically evaluating CRO and service provider proposals ,negotiating SOW terms, and growing and fostering long-term, healthy strategic relationships
· Knowledgeable in the use of industry benchmarking data sets (e.g. Grant plan, etc)
· Experience with practices for all phases of clinical research with an in-depth understanding of the drug development process and the cross-functional responsibilities including clinical trial design, study start-up and execution, monitoring and site management, safety reporting, data management, and biometrics
· Experience with preclinical vendors and contracting is a plus
· Experience in immunology therapeutic areas, specifically related to design /quality oversight of trials is a plus
· Extensive knowledge of Good Clinical Practices (FDA and ICH), a solid understanding of 21CFR Part 11, 50,54,56, & 312 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, eTMF requirements and ICH E-6(R1 & R2)
· Current and working knowledge interpretation/implementation of government and other local state/government regulations/requirements governing the ability to work in a clinical setting, demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions required.
· Ability to think strategically and objectively and with creativity and innovation.
· Excellent leadership skills /ability to lead cross-functional teams of professionals.
· Strong attention to detail and excellent communication and organizational skills
· Able to proactively identify logistical problems and propose solutions
· Treats people with respect; inspires the trust of others; works with integrity and 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; contributes to a positive team spirit; shares expertise /mentors junior colleagues
· 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