Major Responsibilities:

• Support the design, initiation and execution of study protocols in conjunction with cross-functional study team.

• Conduct appropriate literature research and competitive intelligence for the assigned clinical product candidate and trial indications in support of clinical and commercial developmental strategies and priorities.

• Contribute to the development of clinical regulatory documents including study protocol, IB, safety updates, IND submission documents, and health authority query responses, and study CSR

• Collaborate with clinical operations and other internal study team members to develop study documents including Informed Consent Forms, Case Report Forms, and CRF instructions.

• Conduct ongoing and active review of clinical data and facilitate use of data for relevant internal and external deliverables and discussions.

• May act as back-up contact of the clinical study team for medical monitor inquiries with guidance and oversight of the Medical Monitor assigned to the clinical program.

• Collaborates with clinical operations and other study team members in the development of agendas, training materials, and presentations for site visits, investigator meetings, and other study related meetings and discussions.

• Support the preparation and presentation of clinical safety meetings, analyzes and reports potential safety events.

• Support the drafting and review of external study presentations and publications

Technical Skill Sets:

• Comprehensive and detailed working knowledge of clinical trial implementation and drug development process.

• Good general knowledge of other related disciplines in the execution of clinical trials.

• Good working knowledge of clinical trial data systems

• Identifies and implements methods and procedures to achieve results with high quality.

• Performs a variety of complicated tasks with a wide degree of creativity and latitude.

• Has complete understanding and wide application of technical principles, theories, concepts and techniques.

• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.

• Applies strong analytical and business communication skills.

• Highly organized and able to work under tight timelines

• Highly developed verbal, written and presentation skills.

Educational Requirements:

• Bachelors in Science; Advanced Degree Preferred (MS, Pharm.D., or PhD)

Experience Requirements:

• 10 years clinical development experience in the biotechnology or pharmaceutical industry or equivalent experience in academia and industry.

• Experience in clinical oncology studies with molecular targeted or immunological therapies.

Considerations:

• Up to 20% travel