Executive Director, Clinical Research Hematology - Lymphoma

About the role

The Executive Director (Distinguished Scientist) and Product Development Team leader is responsible for planning and directing clinical research activities for new or marketed medicines in the Oncology therapeutic area, Hematology section. The role manages the full late-stage clinical development cycle, from Phase 2 to Phase 5, and leads cross-functional product development teams. The primary location is Rahway, New Jersey.

Key responsibilities

• Evaluate pre-clinical and translational work to generate early clinical development plans and IND applications
• Develop clinical development strategies and execute them, including trial design, operational plans and settings
• Monitor and manage ongoing and new clinical trials, and lead the clinical subteam
• Analyze and summarize clinical findings to support safety, efficacy, NDA, clinical study report and publication decisions
• Lead cross-functional teams and act as the product development team spokesperson
• Manage Clinical Directors and/or Senior Clinical Directors, and foster a high-performance culture
• Work with commercialization, regulatory affairs, statistics and manufacturing, and support business development assessments
• Lead internal governance presentations to senior management and committees, and escalate issues
• Maintain a strong scientific fund of knowledge, identify and communicate with prominent investigators, and attend scientific meetings
• Travel about 20% of the time on company business

Required profile

• M.D. or M.D./Ph.D.
• Minimum 3 years of clinical medicine experience
• Minimum 5 years of industry experience in drug development, with success overseeing multiple studies and protocols
• Experience authoring regulatory documents and leading discussions with regulatory agencies
• Record of scientific scholarship and achievements, and background in biomedical research
• Preferred: board certification or eligibility in Oncology, Hematology or a related discipline, lymphoma experience, prior clinical research experience and publications, and product registration experience

Required skills

• Clinical development and clinical trial development
• Regulatory compliance
• Program strategy and senior program management
• Scientific leadership and mentorship
• Strategic planning and interdisciplinary problem solving
• Matrix environment and clear verbal and written communication

What we offer

• Salary range of $310,900 to $489,400 depending on qualifications, experience and location
• Eligibility for annual bonus and long-term incentives, if applicable