Senior Global Development Scientist – Director

• Convert program strategy into study concept documents, protocols, ICFs, CRFs, TFL shells, and related materials
• Own the scientific rationale and clinical integrity of protocols and clinical plan components
• Deliver final protocols and secure governance approvals with Study Physician, GCPL, and GCH partners
• Drive timely study initiation and execution with Clinical Operations, Program Management, GSTs, SMM, supply chain, and sample management
• Identify recruitment risks, propose mitigations, and support implementation
• Provide clinical input to feasibility questionnaires and country/site selection
• Respond to site queries and EC/IRB requests
• Lead study-level medical monitoring and safety reviews when applicable
• Lead high-level clinical data reviews and interpretation
• Prepare governance materials for Go/No-Go decisions
• Lead development and delivery of clinical study reports
• Support health authority interactions and regulatory and EC/IRB submissions
• Provide clinical input to NDA/BLA registration packages
• Collaborate on launch, branding materials, and publications
• Partner with investigators, KEEs, MSLs, and SMMs on study design, feasibility, and recruitment
• Contribute to advisory boards and deliver investigator and monitor training
• Represent Clinical Development as a core GST member
• Lead process improvements and contribute to cross-asset or cross-tumor working groups
• Mentor and develop less experienced team members and provide line management as appropriate

• PharmD, Ph.D. degree in life sciences, or MD preferred
• 7+ years of industry or academic experience in drug development required
• Strong preference for oncology experience
• Foundational knowledge of FDA and other major country regulations
• Detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research
• General knowledge of medical monitoring, regulatory approval processes in relevant countries, pharmaceutical industry/R&D operations, and marketing and commercial fundamentals
• Significant oncology therapeutic experience
• Ability to independently lead components of complex clinical development plans, documents, methodologies, analysis plans, and evaluation tools
• Experience driving protocol design, writing, and implementation to GCP, ICH, and internal quality standards
• Experience with novel endpoints, biomarkers, adaptive or innovative trial designs, and advanced analytical approaches
• Strong communication and presentation skills
• Experience contributing to and leading clinical reports and integrated summaries for complex global projects
• Experience leading study-level medical monitoring and safety reviews
• Experience operating in global, matrixed teams across multiple countries and time zones
• Track record of mentoring or managing clinical staff
• Ability to influence and build consensus across diverse stakeholders
• Advanced oncology therapeutic area expertise across multiple tumor types

Demonstrates extensive experience in clinical development, particularly in oncology, with a strong foundation in regulatory compliance, Good Clinical Practice (GCP), and the ability to lead complex clinical study designs and protocols. Proven track record in mentoring teams and collaborating with diverse stakeholders to drive successful study execution and governance.

• Oncology Experience
• Clinical Development Leadership
• Good Clinical Practice (GCP)
• Regulatory Approval Processes
• Medical Monitoring

• Clinical Study Design
• Protocol Development
• Data Analysis
• Regulatory Submissions
• Feasibility Assessment
• Clinical Report Writing
• Adaptive Trial Design
• Biomarker Analysis
• Evaluation Tools
• NDA/BLA Registration

• Strong Communication Skills
• Mentoring
• Consensus Building
• Team Leadership
• Presentation Skills

• PharmD
• Ph.D. in Life Sciences
• MD

• FDA Regulations
• Good Clinical Practice (GCP)
• Clinical Research
• Pharmaceutical Industry
• Oncology Therapeutics
• Global Clinical Trials
• Clinical Operations
• Cross-Asset Collaboration
• Health Authority Interactions
• Integrated Summaries