Director, Project and Operations Management
CrystalGenomics is headquartered in Seoul, South Korea and has a U.S. subsidiary (CG Pharmaceuticals, Inc.) in Orinda California for the management of global clinical trials and is publicly traded on the KOSDAQ exchange. In addition to several clinical stage programs in development, the Company has a marketed product, Acelex® (polmacoxib), a next generation NSAID indicated for osteoarthritis and has recently added manufacturing and commercialization capabilities through multiple acquisitions. For more information, please visit: www.cgxinc.com or www.crystalgenomics.com.
Director, Project and Operations Management
Location: San Francisco, Bay Area
In this role, you will have the opportunity to work independently and collaboratively in an exciting company. The Project and Operations Director will be accountable for leading day-to-day operations of one or more clinical studies, ensuring efficient delivery of the project and clinical trials in a matrix environment. This activity is coordinated in conjunction internal and external stakeholders, including the project team from with one or more CROs. This position will report to the President, CG Pharmaceuticals. This is a full-time position.
Responsibilities may include, but are not limited to:
- Lead study and project management team meetings, conceptualizing the execution strategy for each component of the study and project, to drive progress, track and mitigate risks, resolve/escalate issues, and review action items.
- Preparing project management plans, timelines and identifies all significant activities, dependencies, resources, and milestones to assist cross-functional and external activities.
- Recommends and implements innovative ideas to increase efficiency and quality of project management activities.
- Facilitate operational activities pertaining to the execution of early- and late-stage clinical trials from study start through close-out.
- Primary contact for functional area representatives and vendors responsible for protocol execution.
- Provide oversight of CROs, service providers and consultants that are involved in assigned studies.
- May assist in the development and review of Investigator Brochure, study protocols, informed consent forms, case report forms, study plans, clinical study reports, study materials and tools.
- Establishes study milestones and ensures accurate tracking and reporting of study progress.
- Prepares study budgets and timelines.
- Ensure studies are managed and executed in accordance with ICH GCP, regulations, the protocol and company SOPs.
- May conduct site visits (in conjunction with CRO, if applicable) for oversight, site evaluation, initiation, monitoring, or close-out activities.
- Participate and respond to Quality Assurance and regulatory authority inspection audits.
- Responsible for and participates in service provider selection process as a part of outsourcing activities.
- Responsible for selection and study specific training of CRO study staff, monitors, investigational sites, and service providers.
- A minimum of 12 years of Clinical Project Management and/or Clinical Operations experience at a Sponsor or CRO, preferably in hematology/oncology or a MS or MBA.
- Experience should include 6 years of participation in cross functional project management in various stages of development.
- Knowledge of the drug development process with 6 plus years and a PhD in a scientific field or a PharmD, DVM, or MD degree.
- Project Management Certification: PMP or equivalent is desirable, with working knowledge of associated methodologies and principles.
- Solid understanding of applicable clinical research and scientific concepts and regulatory requirements.
- Excellent communication skills both verbal and written are required; Fluent in Korean, preferred.
- Strong problem-solving skills with the ability to focus on time-sensitive objectives and proven flexibility adapting to a rapidly evolving workload.
- Excellent IT skills, particularly MS Office Excel, Word, Project and ability to track costs/budgets/financial reporting relating to project execution.
- Able to communicate and work with cross functional team, internally and externally.
- Thorough understanding of ICH GCP guidelines.
- Understanding of clinical trial processes and experience in driving execution, from study start-up through study closure, (e.g., data management, safety, biostatistics, medical writing).
- Self-motivated, assertive and able to function independently or as part of a team.
- Effective in selection of investigative sites, CROs, and vendors and management of external resources.
- Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners).
- Proven problem solving and decision-making skills and must be able to work under minimal and at times no supervision, determine personal work plan, and schedule tasks and activities.
- Ability and willingness to travel 10-20% (domestic and international).