City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
Position Summary and Key Responsibilities:
The Project Manager interacts with other BRI offices including business management, manufacturing, quality systems, regulatory affairs, technology licensing, research finance and OSR and external organizations and investigators. Assists the PI in managing operations and project management ensuring that projects are completed on time and within budget. Evaluates operational programs for optimal performance. Assists the PI in writing and editing proposals, grants, papers, project reports and other documents. Assists the Business Manager and PI in managing ongoing project budgets and in final project close outs. Excellent written and verbal communication skills are required due to the high level of communication. Coordinates several projects simultaneously. Projects include internal projects as well as external multi-party projects that are often complex and involve academic and for profit partners and collaborators. Provides primary point of contact for internal and external project communications and coordination. Projects relate to the development and production of novel biological and cell therapy products. Projects are funded through institutional, State and Federal grants and contracts, as well as through third party corporate sources and are generally high dollar and involve high profile research programs. Projects range from several months to several years.
Coordinate activities for pre-IND, IND and Phase I protocol. Interacts with COH internal study/project team(s), external contract research organizations (CROs), vendors and regulatory authorities (i.e., FDA) regarding pre-IND and IND and Phase I protocol. Manage the Phase I protocol and related grants preparation, submission to CPRMC and IRB for review. Manage activities among clinical research associates, research nurses, and pharmacokinetic laboratory and pharmacodynamic laboratories for the drug discovery compound(s). Interacts with the Clinical Trial Office for Adverse Effect Report and Data Safety Monitoring Plan.
Program and Project Management
- Under direction of the BRI PI and the departmental Business Manager, assesses programs for optimal performance. Exercises effective project management skills to ensure projects meet timelines and milestones. Manages projects in order to complete on schedule and within budget.
- Coordinates with other BRI offices including business management, multiple core services, manufacturing, quality systems, regulatory affairs, and technology licensing, and external organizations and investigators.
- Responsible for managing and coordinating multiple projects simultaneously. Works with PI and BM, to develop budgets, timelines, identify risks and develop plans to mediate risks for internal and external projects. Develops project plans and schedules, manages project initiation, execution, and closeout of projects. Maintain and promotes open communication. Keeps PI informed of project activities and progress.
- Audit the validation of data from each lab, standardization of compounds or samples in testing, maintain data fidelity.
- Maintains deliverables and reports of all projects. Prepare project progress reports and general reports for distribution for internal or external projects
Grants and Contracts
- Assists in writing and editing proposals, grants, papers, reports and other documents.
- Leads communication and provides deliverables with external and internal Clients. Represents program at conferences, and meetings.
- Interacts with COH internal study/project team(s), external contract research organizations (CROs), vendors and regulatory authorities (i.e., FDA) regarding pre-IND and IND progression.
- Communicates with outside contracting laboratories and takes minutes of meeting. Collects internal and external documentation for reporting to FDA.
- Compiles data into the appropriate format for pre-IND and IND filing.
- Assembles pre-IND documents for pre-FDA meeting and regulatory packages for submission to FDA for IND filing. After IND filing, assist Principal Investigator with development of Phase I study protocol. Maintains documentation of all activities pertinent to pre-IND, IND filing and Phase I study protocol.
- Serves as liaison to GMP facility.
- Coordinates quarterly and and annual advisory board meetings, pre-IND meetings, and clinical planning meetings.
- Once the project moves into the clinical phase, will manage and coordinate the Phase I protocol preparation, submission to CPRMC and IRB for review.
- Coordinates activities among clinical research associates, research nurses, and pharmacokinetic laboratory and pharmacodynamic laboratories for the drug discovery compound(s).
- Interacts with the Clinical Trial Office for Adverse Effect Report and Data Safety Monitoring Plan.
- Manages and compliance with and provides required reports to SCRO, IBC, IACUC, etc.
- Assist BRI PI in the preparation of external business proposals and budgets.
- Serves as a technical resource for the Department and assist in the editing of manuscript and other proposals, technical, regulatory and progress reports as needed.
- Excellent verbal and written communications skills.
- Is self-motivated in organizing and following through on assigned projects.
- Ensures work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center.
- Maintains professional growth and development through seminars, workshops, and professional affiliations to maintain certification/licensure, and/or keep abreast of latest trends in field of expertise.
- Maintains current knowledge and awareness of organizational and regulatory standards, policies and procedures. Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, includingadherence to theworkplaceCode of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Minimum Education and Skills Required for Consideration:
- Master's Degree or Ph.D. in a medical or scientific discipline, with a minimum of five years of progressively responsible program management experience in an academic or independent biomedical research environment.
- A minimum of two years experience in multi-programmatic management required.
- Biological Sciences, Science, Chemistry, Public Health or related field.
- Excellent writing skills.
- Ability to function independently in the field with minimal supervision.
- Excellent oral/written communication and organizational skills
- Excellent reading comprehension
- Foster/promote a positive image and professional appearance
- Sensitivity to intercultural relations
- Compile data
- Proofread documents
- Research information
- Troubleshoot programs
- Use computer packages
- Use word processing software
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.