Associate Director/Director, Clinical Science Contractor

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