Clinical Development Executive Medical Director, Hematology

Role Summary

Clinical Development Medical Executive Director, Hematology. Responsible for defining and executing the development strategy of hematology programs. Reports to the Global Development Product Lead and collaborates cross-functionally to advance programs and represent them externally. May lead one or more subteams in clinical development and serve as the clinical lead across multiple clinical trials; prior experience in clinical trials, supporting development programs, health authority interactions, and demonstrated leadership is preferred.

Responsibilities

• May lead product specific Global Development Team
• Serves as the subject matter expert on clinical issues
• Work across the organization and on the cross-functional Global Development Team to lead, develop and execute the clinical development plan of one or more hematology indications in alignment with the Lifecycle Management Plan and Integrated Product Plan
• Endorses clinical decisions in advance of GPT, senior management reviews or governance bodies with the GDPL
• May provide oversight and management responsibilities of medical director(s)
• Accountable for the clinical development strategy, trial design, execution, and delivery of trial results with the GDPL
• Accountable for integrating regulatory, statistical and other internal and external stakeholder input into study designs
• Serves as primary interface with Development Review Committee
• Oversee the development and management of clinical protocols and amendments, investigator brochures, and clinical study reports
• Oversee the evaluation, interpretation, reporting and presentation of study data
• Accountable with safety for clinical evaluations and safety decisions, escalating to GDPL as necessary
• Accountable with clinical pharmacology for defining and identifying optimal dose and schedule selection
• Accountable with regulatory for health authority interactions, escalating to GDPL as necessary
• May participate in evaluating business development opportunities
• Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring
• Lead peer-to-peer interactions with investigator
• Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities
• Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team
• Oversee and provide clinical development leadership across several study teams
• Serves as the Clinical Development Lead on working groups and subteams including for Marketing Authorization Applications and in business development opportunities

Responsibilities (Strategic Guidance, Clinical Insights & Interpretation)

• Lead, develop and execute the strategic development of therapies for one or multiple medicines in designated therapeutic area, collaborating with the GDPL as needed
• Represents the company in external engagements or as committee members in joint collaborations
• Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders
• Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans

Qualifications

• Required: Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years).
• Required: 7+ years industry experience
• Required: 5+ years of experience leading diverse teams
• Required: Prior management responsibilities of medical directors or clinical scientists
• Preferred: Board certified/eligible in oncology or equivalent
• Preferred: Experience across multiple phases of clinical development and across drug classes in oncology
• Preferred: Experience in leading NDA, BLA or MAA

Additional Requirements

• Global Travel May Be Required
• Relocation assistance may be available
• Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.