Senior Global Development Scientist

• Convert program strategy into study concept documents, protocols, informed consent forms, case report forms, and TFL shells
• Own the scientific rationale and clinical integrity of protocols and clinical plan components
• Deliver final protocols and secure governance approvals
• 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 content for Go/No-Go decisions
• Lead development and delivery of clinical study reports
• Support health authority interactions and regulatory 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
• Develop and deliver investigator and monitor training
• Represent Clinical Development as a core GST member
• Lead or contribute to process improvements and 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
• General knowledge of regulatory approval processes in relevant countries
• General knowledge of pharmaceutical industry/R&D operations
• General knowledge of marketing and commercial fundamentals
• Significant oncology therapeutic experience
• Ability to independently lead components of complex clinical development plans, related documents, methodologies, analysis plans, and evaluation tools
• Experience with protocol design, writing, and implementation to meet 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 operations, biostatistics, regulatory, safety, and commercial stakeholders
• Advanced oncology therapeutic area expertise across multiple tumor types

Demonstrates extensive expertise in clinical development, particularly in oncology, with a strong foundation in regulatory compliance, Good Clinical Practice (GCP), and protocol design. Proven ability to lead complex clinical studies, mentor teams, and collaborate effectively across multidisciplinary stakeholders.

• Oncology Experience
• Clinical Development Leadership
• Regulatory Compliance Knowledge
• Protocol Design and Implementation
• Medical Monitoring Expertise

• Clinical Study Design
• Protocol Writing
• Regulatory Submission Preparation
• Data Review and Interpretation
• Feasibility Assessment
• Clinical Report Development
• Advanced Analytical Approaches
• GCP Knowledge
• NDA/BLA Registration
• Innovative Trial Designs

• Strong Communication Skills
• Mentoring and Team Development
• Consensus Building
• Presentation Skills
• Collaboration

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

• Good Clinical Practice (GCP)
• FDA Regulations
• Clinical Operations
• Pharmaceutical R&D
• Oncology Therapeutics
• Global Clinical Trials
• Biostatistics
• Safety Reviews
• Health Authority Interactions
• Clinical Development Plans