Clinical Scientist/Sr. Clinical Scientist, Oncology

Responsibilities:

• Act as clinical scientist and clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs
• Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question
• Provide scientific oversight for Company operational staff, contract research organizations (CROs), and clinical trial sites in all areas related to the therapeutic programs
• Collaborate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents
• Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
• Acts to provide clinical oversight and contributes to safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee
• Play a key role in the analysis, interpretation and delivery of high-quality clinical data
• Interact with principal investigators and opinion leaders to facilitate clinical trials research
• Participate in appropriate regulatory discussion and activities, including the filing of IND’s, CTXs, NDA/MAAs, throughout the development cycle
• Participate in clinical study report conceptualization, development and writing for global regulatory submissions
• Work closely and collaboratively with other functions, e.g. clinical operations, safety, biometrics, regulatory, medical writing, medical affairs and commercial
• Develop and give internal and external presentations as subject matter expert for the therapeutic area
• Participate in the development and review of publications
• Prepare and monitor budgets in collaboration with clinical operations and R&D finance
• Serve as liaison to the commercial team on scientific issues

Preferred Skills, Qualifications and Technical Proficiencies:

• Strong clinical and scientific knowledge
• Excellent communicator with proven leadership skills and the ability to interact in a cross functional environment
• Comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities

Preferred Education and Experience:

• Pharm D, PhD, MD or equivalent, preferably with experience in oncology therapeutic area(s)
• 0-2+ years of relevant clinical development experience is preferred
• Relevant clinical research experience in academic settings is desirable