Director, Clinical Science

United StatesRemote

Responsibilities

Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria
Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
Ensure study manuals align with protocol and engage investigators in study design
Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones
Support meetings (advisory boards, etc) and deliver presentations
Drive clinical research plans, including company and investigator-initiated studies
Build relationships with KOLs, consortiums, and sites
Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff, as needed
Ensure HIPAA/PHI compliance and maintain training requirements
Perform other duties as assigned

Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biostatistics, translational medicine, and program leadership. PRIMARY RESPONSIBILITIES:
Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) preferred
experience in clinical development in oncology clinical trials
Deep understanding and preferably
experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection •
Experience in data review, data cleaning, managing and interpreting clinical trials results as well in writing clinical trial protocols
Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research •
Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately
Ability to work independently and collaboratively