Director, Translational Development

About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 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 leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary
The Director of Translational Development is responsible for the management and support of industry-sponsored and/or investigator-initiated, pharma-funded projects from initial pre-clinical development to clinical trial performance, as needed and agreed upon between City of Hope and the industry sponsor of internal drug development projects. The Director of Translational development is a detail-oriented, responsible team player with a sense of urgency, who can ensure project completion within set timelines, budget and resources. The Director utilizes best practices for planning and tracking performance of milestones and setting priorities that are associated with preclinical and clinical projects and can ensure project completion within set timelines, budget and resources.

The Director is an integral member of the newly formed Translational Development Center (TDC) which is housed in the City of Hope (COH) Research Operations vertical ensuring effective communication among team members and with other stakeholders, and influences/gains the cooperation of others to drive projects forward.

Key Responsibilities include:

• Coordinates the design and execution of cross-functional project plans for pre-clinical development and clinical trial performance of small / large / nucleic acid molecule and cell therapeutics. This will involve the mapping of preclinical and clinical trial development efforts and all other relevant information, with a variety of project management tools.
• Advise and assist investigators and/or their personnel with coordination of writing and preparation of agreements, budgets, meeting minutes, reports, regulatory applications, grants, as well as compliance documents.
• Maintains frequent communication with the cross-functional project team members and key internal stakeholders [e.g. Cell Therapy Governance Committee, Disease and Modality Teams] so that all parties are aware of current project status, issues, contingencies, and milestones.
• Guide the project team to ensure that protocols/applications/ continuations for Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), Laboratory Information Management System (Labware LIMS), Institutional Review Board (IRB), Investigational New Drug Applications (IND) are set up, renewed and amended on time and accurately for each specific project. Prepare documents, as needed, i.e., clinical protocol, patient consent forms, IACUCC protocols, Data monitoring and safety charters, IBCs and related documents.
• Prepares summary information on program progress, timeline updates and risk assessment for periodic presentations to City of Hope oversight committees. Coordinate meetings and teleconferences as needed to facilitate the activities listed in the Scope of Work and to ensure that the appropriate COH or external entities involved in the translation for each project are well informed about project progress and milestones.
• Manage the activities listed in the Statement of Work (SOW) for each Sponsored Research Agreement, Clinical Research Support Agreement, or similar agreement with industry partners, including budgets, resources and project-related activities to ensure the completion of the projects according to the timelines and within budget.
• Leads and/or participates in team meetings and ensures that clear actions and decisions are documented, communicated and committed to, enabling timeline achievement.
• Builds strong working relationships across departments, with key stakeholders, and Senior Management to ensure transparency and to facilitate communication. Collaborates with CROs, small to medium biotechs and other critical functional areas to ensuring critical program activities are well coordinated and milestones are met.
• Oversee one or more industry-sponsored translational projects and Manages multiple industry sponsored translational projects simultaneously to include preparing project plans, allocating resources, prioritizing projects and maintaining communication regarding project status.
• Possesses a deep understanding of the translational projects to achieve the goals of each industry-sponsored project under their management, as well as of the logistics of each project from preclinical experiments and IND-enabling studies to clinical trial design, protocol and IND preparation, conduct of clinical trials, and commercialization.
• Collaborates with COH Research Operations, with the Office of Technology Licensing, Clinical Trial Support Services, Clinical Research Billing, Research Finance Clinical Trials Office, the Center for Biomedicine and Genetics, the T-Cell Translational Research Laboratory, the Office of IND Development and Regulatory Affairs, COH Shared Resources and laboratory and clinical laboratories to shepherd projects from proof-of-concept in the laboratory to clinical testing.
• Responsible for escalating appropriately and in a timely manner while identifying mitigation strategies to rectify issue(s). Communicate clear and timely deadlines, meeting outcomes (captured in minutes shared with all parties involved), issues (delays, shortcomings, disputes, etc.), and any information that impacts the project and its accomplishment.

Basic education, experience and skills required for consideration:

• Requires a PhD in biology, immunology, virology, or other life science; or, a master's degree with at least five years of laboratory management, clinical and animal protocol submissions and maintenance, or clinical trial regulatory experience in a healthcare/research/academic environment
• 7 years of experience laboratory management, clinical and animal protocol submissions and maintenance, or clinical trial regulatory experience in a healthcare/research/academic environment with
• 5 years proven experience managing multiple development projects.
• Strong scientific background with outstanding project management, communication and interpersonal skills.
• Effective oral and written communication skills to influence, inform and guide a large clinical development team.
• Excellent interpersonal skills.
• Excellent human relation skills
• Experience working with multi-disciplinary and matrixed teams.
• Ability to work independently and as part of a team, meet deadlines, and perform and prioritize multiple simultaneous tasks. Requires judgment that could affect the image of City of Hope
• Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams.
• Excellent organizational skills.
• Demonstrated ability to work effectively with cross functional groups and participate in problem solving process.
• Innovative, driven, highly organized self-starter with the ability to handle multiple activities and comfortable interacting with all levels of management within the organization.
• Proven ability in negotiating/influencing and collaboration skills.
• Experience with project management approaches or tools, project planning, timeline and budget management.
• Ability to instruct, train & interview others.
• Ability to maintain staffing levels, monitor productivity and staffing.
• Able to delegate tasks and to troubleshoot problems.

Preferred education experience and skills:

• PhD degree in Biology, Immunology, Virology, or other life science.
• 5 years of post-graduate program management experience in managing multiple development projects biology, immunology, virology, or other life science
• Familiarity and experience working with pre-clinical and clinical development partners.
• Program management experience and demonstrated contributions to successful regulatory filings (IND/CTA).
• Involvement with human observational or therapeutic studies and protocol design/writing for animal and human observational/retrospective or therapeutic studies; familiarity with project management, IRB, IACUC, IBC, FDA and other regulatory bodies; and data analysis techniques, graphing methods, and interpretation of laboratory and clinical data.

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.

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• Posting Date: Sep 17, 2021
• Job Field: Clinical Research
• Employee Status: Regular
• Shift: Day Job