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.
This position is based in South San Francisco. No relocation assistance provided.
In this role, you will be responsible for the strategic planning, successful implementation and management of clinical trials that includes: CRO /vendor and study site selection, set-up and oversight, as well as management of the recruitment, execution and completion of clinical trials. This role will ensure clinical trials are executed on time and within budget. You will build and maintain strong, collaborative relationships across all DiCE functional areas that interact with Clinical Operations, including Regulatory, Biometrics, Development Sciences, Project Management, Research and Quality Assurance to enable successful completion of all clinical activities and project deliverables. You will be responsible to assure adherence to GxP in conduct of DiCE clinical trials, 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.
· Serves as the cross-functional study team and Clinical Operations leader for one or more clinical studies; drives study goals by working closely and communicating effectively with internal and external study team members
· Oversees all trial management efforts for assigned studies from early planning through CSR and vendor close-out with the support of one or more Clinical Trial Associates
· Maintains and/or accelerates timelines for achieving program milestones, as defined by Clinical Operations leadership
· Leads the identification, qualification and selection of CROs and third-party study vendors. Oversee performance of CROs, third party vendors, and CRAs through vendor management tactics to ensure compliance with study protocol and in accordance with scope of work; identifies areas of concern and escalates to the Clinical Operations leadership, as appropriate.
· Leads and /or contributes to the development of study plans and documents, including informed consent forms (ICFs), protocols, and amendments, project management plans, study reference manuals, etc., and assists in writing clinical portion of Regulatory submissions
· Develops and oversees study-specific training plans and Investigator Meetings; plays a key role in representing DiCE through delivery of presentations at Investigator Meetings
· Serves as the primary Sponsor contact for CROs and vendors; maintains day-to-day contact with vendor counterparts; including a daily review and identification of potential issues or problems
· Compiles and maintain regular status reports of study timelines, progress and risks, presenting routine updates to cross-functional study team and Clinical Operations leadership
· Participates in the review of clinical data in the EDC, data listings, or report tables; ensures that all study data and documentation from Investigators and investigational sites meets FDA/GCP/ICH regulations, assuring studies are carried out according to the study protocol, SOPs, study-specific manuals and procedures, as well as DiCE quality standards
· Establishes mechanisms for quality /risk management oversight and improvement related to assigned studies; tracks and monitors protocol deviations and related follow-up
· Oversees the review, approval, and tracking of clinical monitoring visit reports and ensures that all outstanding follow up items are closed out in a timely manner; occasionally attends SIVs, IMVs, and COVs to ensure Regulatory and study requirements are being fulfilled
· Serves as a Sponsor resource to study coordinators, Investigators and other staff members regarding investigational products, protocols and /or to resolve any issues
· Assists in preparation, negotiation and management of and adherence to study budgets; perform initial review of CRO and vendor invoices
· Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial; ensures proper archival of all study related data and records
· 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 the development of new SOPs within department
· Mentor junior staff in acceptable clinical practices, participating in hiring activities, etc.
· Expands knowledge of clinical trials operations and scientific principles and objectives of DiCE’s clinical trials under some direction and guidance of senior staff but largely self-directed; works independently but knows when to involve / collaborate with others
· Builds best practices in clinical operations 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
· Completes a variety of other clinical trial-related responsibilities as assigned and agreed upon with direct manager
· Actively participates in Clinical Operations departmental meetings and initiatives; proactively contributes ideas to enhance the efficiency and effectiveness of Clinical Operations
· Participate in and/or lead forums critical to Clinical Operations objectives
· Travel required: potential domestic and international travel, up to 20%
Preferred Experience and Education:
· Bachelor’s degree in scientific field, or equivalent training and experience
· Minimum of 5 years of direct experience in Trial Management role (Sponsor preferred)
· Minimum 2 years direct oversight of CTMS, EDC, eTMF, clinical trial databases /systems
· Prior experience as a Study Coordinator or CRA is a plus
· Early Development experience required. Start-up experience 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 21 CFR 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
· Extensive knowledge and understanding of clinical trial processes as well as quality management and control tools is required
· Proven ability to manage multiple projects while maintaining quality is required
· Proactive, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with stakeholders.
· Demonstrated success in analyzing, interpreting and solving complex issues across multiple functions in support of conducting quality global clinical trials.
· 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
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.