Clinical Development Executive Medical Director, Thoracic

About the role

This position is for a Clinical Development Medical Executive Director supporting Thoracic Cancers. The Clinical Development Medical Executive Director will be responsible for defining and executing on the development strategy of oncology program(s).

Responsibilities

• May lead product specific Global Development Team (GDT)
• Serves as the subject matter expert on clinical issues
• Works across the organization and on the cross-functional Global Development Team to lead, develop and execute the clinical development plan of one or more indications in alignment with the Lifecycle Management Plan and Integrated Product Plan
• Endorses clinical decisions in advance of Global Product team (GPT), senior management reviews or governance bodies with the Global Development Product Lead (GDPL)
• Provides 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
• Oversees the development and management of clinical protocols and amendments, investigator brochures, and clinical study reports
• Oversees 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
• Conducts medical monitoring activities including eligibility assessment, data review and safety monitoring
• Serves as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities
• Leads peer-to-peer interactions with investigator
• Serves as the Clinical Development Lead on working groups and subteams including for Marketing Authorization Applications and in business development opportunities
• 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 in as committee members in joint collaborations
• Collaborates 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

• Medical degree or advanced degree with relevant clinical/industry experience (typically 5+ years)
• Been licensed/registered by a medical licensing authority to prescribe medicines independent of Supervision for at least two years
• 5+ years of experience leading diverse teams
• Prior management responsibilities of medical directors or clinical scientists
• Late phase drug development experience

To be considered for this role, candidates must be authorized to be employed in the U.S. by any employer.