The Executive Director, Clinical Development - Oncology (MD) oversees the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities.

Essential Requirements:

• MD degree is required, Board Certification in oncology or related field is a plus.
• 15+ years relevant clinical science/medical affairs experience in oncology is required
• Extensive experience in clinical study design in oncology is required
• 8+ years previous management experience may be required.
• Strong ability and desire to solve problems with innovative solutions along with strong organizational skills.
• Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential.
• Extensive experience and understanding of ICH, and GCP is required, knowledge of GMP and GLP is preferred.

Core responsibilities include:

• Create and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports.
• Recruit clinical investigators and negotiate study design and costs
• Oversee human clinical trials, phases I-IV for company products under development
• Responsibilities also include adverse event reporting and safety responsibilities monitoring.
• Coordinate and develop reporting information for reports submitted to the FDA.
• Ensure adherence to protocols and determine study completion.
• Act as consultant/liaison with other corporations when working under licensing agreements.
• Select, develop, and evaluate personnel to ensure the efficient operation of the function.
• Collaborate on abstract problems across functional areas of clinical development and medical affairs.
• Identify and evaluate fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products.
• Interact internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies.
• Oversee the development and management of Clinical Development Plans (CDP) which includes timelines, budget and resource requirements.
• Ensure development and implementation of clinical program strategy and direct those systems and programs to meet Company goals and objectives.
• Create and chair the Medical Advisory Board for proprietary products.
• Oversee the design of pivotal clinical studies for product and registration.
• Identify and develop collaborations with external investigators and opinion leaders.
• Collaborate with cross-departmental teams as, Clinical Research, Regulatory Affairs, Clinical Operations, Marketing and Business Development.
• Act as a clinical opinion leader working with physicians at a peer level.
• Oversee and coordinate efforts to address medical and scientific issues.
• Provide clinical analysis, scientific and clinical support for expansion of market share of Company products.
• Provide guidance to the business in the development of promotional materials and the training of product representatives.
• Oversee and perform medical monitoring.
• Drive the development of publications arising from studies and other relevant initiatives.
• Act as a mentor to junior staff.
• Remain current with medical developments and publications on similar and competitor products.
• May have responsibility for internal staffing and performance management, including hiring, training, coaching and performance reviews.