Executive Director, Product Development Team Leader, Clinical Research, Hematology - Lymphoma

Primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic area, Hematology section. Oversees the entire cycle of late-stage clinical development from Phase 2 to Phase 5, including program strategy, protocol authoring, trial initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings.

Responsibilities

• Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug (IND) applications.
• Develop clinical development strategies incorporating scientific developments, regulatory requirements, competitive landscape, and commercial considerations.
• Execute clinical strategy, plan clinical trials (design, operational plans, settings), and lead the clinical subteam.
• Monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed medicines.
• Lead cross-functional product development teams overseeing overall strategy and execution.
• Integrate cross-functional input and expertise, ensuring all perspectives are incorporated into strategy and plans; serve as the product development team spokesperson.
• Analyze and summarize clinical findings to support decisions on safety, efficacy, new drug applications, clinical study reports, or publications.
• Participate in internal and joint internal/external research project teams for new and marketed compounds.
• Support business development assessments of external opportunities.
• Manage Clinical Directors and/or Senior Clinical Directors, demonstrating effective leadership and fostering a high-performance culture.
• Collaborate with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
• Assist the Associate Vice President and/or Vice President in informing appropriate personnel about study progress, competitor drugs, and expert opinions on scientific questions.
• Lead internal governance presentations to senior management and committees, ensuring alignment and facilitating issue escalation and collaboration for governance approval.
• Maintain a strong scientific fund of knowledge by staying updated on new scientific findings and research methodologies.
• Identify scientifically and operationally strong investigators to assist in drug development.
• Establish communications with prominent clinical investigators in the field of interest.
• Attend scientific meetings to maintain competency and awareness of research activities.
• Author and/or oversee development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitate collaborations with external researchers globally.
• Travel approximately 20% of the time to manage clinical research projects.

Requirements

• M.D. or M.D./Ph.D. required.
• Minimum of 3 years of clinical medicine experience.
• Minimum of 5 years of industry experience in drug development with demonstrated success in overseeing multiple studies and protocols through completion.
• Experience in authoring regulatory documents and leading discussions with regulatory agencies.
• Demonstrated record of scientific scholarship and achievement.
• Proven track record in clinical medicine and background in biomedical research.
• Outstanding interpersonal and collaborative skills, with ability to function in a matrix environment.
• Excellence in delivering clear, impactful communication verbally, in writing, and during presentations.

Preferred Qualifications

• Board Certified or Eligible in Oncology, Hematology, or related discipline.
• Lymphoma experience.
• Prior specific experience in clinical research and publication record.
• Product registration experience.

Skills

• Clinical Development
• Clinical Judgment
• Clinical Medicine
• Clinical Reporting
• Clinical Research Management
• Clinical Trial Development
• Clinical Trials
• Data Analysis
• Decision Making
• Drug Development
• Early Clinical Development
• Ethical Standards
• Hematology
• Intellectual Curiosity
• Interdisciplinary Problem Solving
• Lymphoma
• Mentorship
• Pharmaceutical Development
• Program Strategy
• Regulatory Compliance
• Scientific Consulting
• Scientific Leadership
• Scientific Publications
• Senior Program Management

Pay

The salary range for this role is $310,900.00 - $489,400.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Comprehensive medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

Schedule

• Hybrid work arrangement.
• Travel requirements: approximately 20% of the time.