- Serve as a clinical sciences leader on global oncology studies and contribute to program-level activities
- Lead delivery of study strategy and design and understand analysis and interpretation of data throughout study conduct
- Lead ongoing clinical data review and medical review of clinical trial data
- Own end-to-end writing of protocols from protocol concept through final study report
- Contribute to informed consent forms and other study-related documents
- Review and enhance project-level clinical development plans
- Support regulatory interactions, briefing documents, presentations, questions, and responses
- Ensure compliance with ICH/GCP guidelines, applicable laws and regulations, and GSK SOPs
- Contribute to end-to-end clinical development strategy
- Review and monitor safety data with pharmacovigilance
- Participate in blinded review of data packages for IDMCs
- Make risk/benefit decisions and take actions to mitigate risks
- Collaborate with oncology staff across global functions and cultivate relationships among study/project teams
- Provide training, education, onboarding, and problem-solving support for clinical trials
- Provide study-level leadership and accountability for safety and regulatory reporting
- Drive or contribute to clinical components of investigator brochures and regulatory submission documents
- Serve as a product, protocol, and project subject matter expert
- Work with external experts to develop abstracts, manuscripts, and study design presentations
Requirements
- Bachelor’s degree in life sciences or related discipline
- 3+ years of experience in the pharmaceutical/biotechnology industry or related clinical experience
- Experience in a pharmaceutical industry or CRO environment in the clinical development process
- Oncology clinical development experience, particularly immuno-oncology
- In-depth experience with study management, global regulatory guidelines, and ICH/GCP
- Experience developing and writing study protocols, study procedures manuals, informed consent forms, and clinical study reports
- Experience working with investigators, site staff, external experts, Contract Research Organizations, and vendors
- Advanced degree (MS, PharmD, PhD) or equivalent clinical research experience is preferred
- Clinical development experience across all phases of development (I-IV) is preferred
- Highly developed communication skills appropriate to the target audience
- Proven expertise proactively identifying issues affecting clinical programs and contributing to cross-functional solutions
- Excellent influencing and negotiation skills
- Excellent leadership skills
Core Competencies
Demonstrates expertise in oncology clinical development, including protocol writing, regulatory compliance, and safety data monitoring. Proven ability to lead cross-functional teams and communicate effectively with diverse stakeholders in the pharmaceutical industry.
Highest-signal resume keywords
- Oncology Clinical Development Experience
- Protocol Writing
- ICH/GCP Compliance
- Clinical Trial Data Review
- Regulatory Submission Documents
ATS Optimization Keywords
Hard Skills
- Study Management
- Clinical Study Reports
- Informed Consent Forms
- Clinical Development Strategy
- Pharmacovigilance
- Data Analysis
- Study Procedures Manuals
- Risk/Benefit Decision Making
- Global Regulatory Guidelines
- Clinical Development Phases I-IV
Soft Skills
- Communication Skills
- Influencing Skills
- Negotiation Skills
- Leadership Skills
- Problem-Solving Support
Certifications & Qualifications
- Bachelor’s Degree in Life Sciences
- Advanced Degree (MS, PharmD, PhD) Preferred
Industry Keywords
- Pharmaceutical Industry
- Biotechnology Industry
- Contract Research Organizations
- Immuno-Oncology
- Clinical Trials