Description

CTT is looking for a program manage/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

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
•       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 and experience managing scientific teams and outside contractors and functions
•       Previous interactions with and ability to communicate with regulatory authorities and the FDA is a plus
•       Experience with oncology programs and products, especially in prostate cancer, is desired
•       Experience through NDA/BLAs is a plus
•       Individual must be authorized to work in the Untied States