Associate Director/Director, Clinical Science Contractor

Apply Description 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