Director, Clinical Development – MD

• Lead the execution of multiple clinical trials in hematologic malignancies
• Partner with internal and external stakeholders to advance a novel CAR T-cell therapy
• Provide medical monitoring to multiple oncology clinical trials
• Lead project teams to design and implement clinical studies
• Write protocols, investigator brochures and clinical study reports
• Review clinical trial documents
• Conduct investigator meetings and lead site initiation visits
• Execute and deploy drug development strategic plans
• Develop contingency plans and provide technical and strategic advice
• Meet milestones and budgets
• Translate research and nonclinical findings into clinical development opportunities
• Interact with clinical investigators and thought leaders
• Work with regulatory affairs and ensure compliance with pharmaceutical industry ethical guidelines
• Collaborate cross-functionally with pre-clinical scientists, translational scientists, business and commercial organizations
• Work with clinical operations, biomarker specialists, CROs and regulatory affairs
• Support and provide input into regulatory filing documents
• Conduct regulatory filings
• Perform other duties as required

• MD or equivalent
• 4+ years of experience managing oncology trials
• Board certification/specialization in Hematology or Oncology
• At least 2 years of relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience
• Experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies
• Knowledge of carrying out hematology/oncology clinical trials, including knowledge of hematology/oncology treatment options
• Strategic leadership and tactical skills
• Excellent initiative and judgment
• Demonstrated ability to positively represent the goals of Kite
• Demonstrated ability to develop and maintain excellent working relationships with internal colleagues and external contacts, including key thought leaders and investigators
• Demonstrated ability to work well in cross-functional teams
• Ability to communicate and work independently with scientific/technical personnel
• Critical thinking, troubleshooting and problem-solving skills
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Comfortable in a fast-paced small company environment with minimal direction
• Able to adjust workload based upon changing priorities
• May travel up to 30%

Demonstrates expertise in leading clinical trials in hematologic malignancies, with a strong focus on CAR T-cell therapy and regulatory compliance. Proven ability to collaborate cross-functionally and manage relationships with key stakeholders while executing strategic drug development plans.

• MD Or Equivalent
• 4+ Years Experience Managing Oncology Trials
• Board Certification/Specialization In Hematology Or Oncology
• Experience Designing And Conducting Clinical Trials
• Strategic Leadership And Tactical Skills

• Clinical Trial Design
• Medical Monitoring
• Regulatory Filing
• Protocol Writing
• Oncology Treatment Knowledge
• Proof-Of-Concept Studies
• First-In-Human Studies
• Contingency Planning
• Budget Management
• Technical And Strategic Advice

• Excellent Initiative And Judgment
• Cross-Functional Team Collaboration
• Critical Thinking
• Problem-Solving Skills
• Self-Motivated

• Board Certification In Hematology
• Board Certification In Oncology

• Hematologic Malignancies
• CAR T-Cell Therapy
• Clinical Operations
• Regulatory Affairs
• Pharmaceutical Industry Ethical Guidelines
• Investigator Meetings
• Site Initiation Visits
• Biomarker Specialists
• CROs
• Clinical Development Opportunities