Job Description
Job Title
Oncology Program Manager/Director
Location
Remote (preferred from Seattle/WA area)
About Cancer Targeted Technology
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.
Job Overview
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.
Responsibilities
- Preclinical
- Design, oversee the execution of, and analyze results of IND-enabling pharmacology and toxicology studies
- Assess new methodologies, animal models, and alternative in silico tools as needed
- Summarize and present data at internal and external meetings
- Contribute to authorship of manuscripts
- Regulatory and Clinical
- Collate and interpret reports from internal and outside contractors and assemble studies for an IND package
- Help concisely prepare, write, present, and defend INDs to regulatory authorities
- Collaborate with regulatory, medical, and CMC consultants, as needed, to prepare regulatory documents
- 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
- Program Management & Business Development
- Identify appropriate CROs, CDMOs and CCOs for contracted preclinical, manufacturing and clinical studies
- 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
- Establish and approve operational objectives and assignments, delegate assignments to outside contractors, and manage internal scientists to meet program objectives
- Forecast budget and staffing requirements for development programs; develop resource strategies, allocating budgets and contractors needed for cost-effective operations
- Develop and maintain strong collaborative partnerships with contract research companies, academic institutions and opinion leaders
- Keep a finger on the “pulse” of new technologies, competition, etc. to anticipate future new product development needs
- Independently identify, help draft and manage company grants from a variety of sources
- Ensure all FDA related QA/QC regulatory requirements for GLP studies and GMP manufacturing are consistently met
- Represent the company at meetings when needed in a professional manner and provide constructive input
- Requirements
- ·PhD degree in life science field or relevant work experience
- 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.
- Outstanding English verbal and written communication skills
- Excellent abilities with Microsoft Word, Excel, PowerPoint, Project/Smartsheet
- Self-starter with the ability to work independently in a virtual environment, and respond to changing demands quickly and in a positive manner
- Ability to communicate short- and long-long-term priorities and budgets for product development
- Proven hands-on experience managing scientific teams and outside contractors and functions
- Previous interactions with and ability to communicate with regulatory authorities (FDA/EMA) is a plus
- Experience with oncology programs and products, especially in prostate cancer, is desired
- Individual must be authorized to work in the Untied States
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