<p><strong>Job Title</strong></p><p>Oncology Program Manager/Director</p><p> </p><p><strong>Location</strong></p><p>Remote (preferred from Seattle/WA area)</p><p> </p><p><strong>About Cancer Targeted Technology</strong></p><p>CTT is pioneering the development of novel drug products targeting pivotal enzyme targets in cancer with a specific focus in prostate cancer. We are searching for highly qualified and collaborative individuals who are looking to make a difference in improving people's lives while working in a motivated and enthusiastic start-up environment.</p><p><br></p><p><strong>Job Overview</strong></p><p>CTT is looking for a program manager/director with a strong preclinical and early-stage clinical program management background in oncology (specific focus in prostate cancer is desired). This individual will be responsible for overseeing day-to-day activities associated with drug development from late stage preclinical studies, IND-enabling studies and early- stage clinical studies and will act as a cross-functional liaison between all internal and external collaborators. This individual will report to the CEO.</p><p> </p><p><strong>Responsibilities</strong></p><p> </p><p><em>Preclinical</em></p><ul><li>Design, oversee the execution of, and analyze results of IND-enabling pharmacology and toxicology studies</li><li>Assess new methodologies, animal models, and alternative <em>in silico</em> tools as needed</li><li>Summarize and present data at internal and external meetings</li><li>Contribute to authorship of manuscripts</li></ul><p> </p><p><em>Regulatory and Clinical</em></p><ul><li>Collate and interpret reports from internal and outside contractors and assemble studies for an IND package</li><li>Help concisely prepare, write, present, and defend INDs to regulatory authorities</li><li>Collaborate with regulatory, medical, and CMC consultants, as needed, to prepare regulatory documents</li><li>Oversee the execution of clinical trials in collaboration with CROs, including study planning and start-up, operational and vendor oversight, trial execution and monitoring, drug supply chain, and trial reporting and close-out</li></ul><p><br></p><p><em>Program Management & Business Development</em></p><ul><li>Identify appropriate CROs, CDMOs and CCOs for contracted preclinical, manufacturing and clinical studies</li><li>Design RFPs and bid/engage CROs and CDMOs and assess budgets, timelines, and personnel resources to complete preclinical, manufacturing, and clinical studies for all pipeline products</li><li>Establish and approve operational objectives and assignments, delegate assignments to outside contractors, and manage internal scientists to meet program objectives</li><li>Forecast budget and staffing requirements for development programs; develop resource strategies, allocating budgets and contractors needed for cost-effective operations</li><li>Develop and maintain strong collaborative partnerships with contract research companies, academic institutions and opinion leaders</li><li>Keep a finger on the “pulse” of new technologies, competition, etc. to anticipate future new product development needs</li><li>Independently identify, help draft and manage company grants from a variety of sources</li><li>Ensure all FDA related QA/QC regulatory requirements for GLP studies and GMP manufacturing are consistently met</li><li>Represent the company at meetings when needed in a professional manner and provide constructive input</li></ul><p><br></p><p><strong>Requirements</strong></p><p><br></p><ol><li>·PhD degree in life science field or relevant work experience</li><li>4-9 years of project management focused on product development in a biotech/pharma environment managing the entire product life cycle: preclinical development, manufacturing, IND-enabling studies, developing clinical plans, preparing and submitting INDs and managing clinical trials or clinical contract organizations.</li><li>Outstanding English verbal and written communication skills</li><li>Excellent abilities with Microsoft Word, Excel, PowerPoint, Project/Smartsheet</li><li>Self-starter with the ability to work independently in a virtual environment, and respond to changing demands quickly and in a positive manner</li><li>Ability to communicate short- and long-long-term priorities and budgets for product development</li><li>Proven hands-on experience managing scientific teams and outside contractors and functions</li><li>Previous interactions with and ability to communicate with regulatory authorities (FDA/EMA) is a plus</li><li>Experience with oncology programs and products, especially in prostate cancer, is desired</li><li>Individual must be authorized to work in the Untied States</li></ol>