Associate Director/Director, Clinical Science Contractor

Responsibilities

• Support the design, initiation, and execution of study protocols in conjunction with cross-functional study teams.
• Conduct literature research and competitive intelligence for assigned clinical product candidates and trial indications to support clinical and commercial developmental strategies.
• Contribute to the development of clinical regulatory documents, including study protocols, Investigator’s Brochures (IB), safety updates, IND submission documents, health authority query responses, and clinical study reports (CSR).
• Collaborate with clinical operations and other internal study team members to develop study documents such as Informed Consent Forms, Case Report Forms (CRFs), and CRF instructions.
• Conduct ongoing and active review of clinical data and facilitate its use for internal and external deliverables and discussions.
• Act as a backup contact for the clinical study team regarding medical monitor inquiries, with guidance from the assigned Medical Monitor.
• Collaborate with clinical operations and other study team members to develop agendas, training materials, and presentations for site visits, investigator meetings, and other study-related discussions.
• Support the preparation and presentation of clinical safety meetings, analyze and report potential safety events.
• Support the drafting and review of external study presentations and publications.

Requirements

• Comprehensive and detailed working knowledge of clinical trial implementation and the drug development process.
• General knowledge of related disciplines in the execution of clinical trials.
• Working knowledge of clinical trial data systems.
• Ability to identify and implement methods and procedures to achieve high-quality results.
• Performs complex tasks with creativity and latitude.
• Complete understanding and application of technical principles, theories, concepts, and techniques.
• Leads or manages the work of others by providing guidance based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
• Strong analytical and business communication skills.
• Highly organized and able to work under tight timelines.
• Highly developed verbal, written, and presentation skills.
• 10 years of 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.
• Up to 20% travel.

Qualifications

Bachelor’s degree in Science; Advanced Degree preferred (MS, Pharm.D., or PhD).