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Senior Director, Global Clinical Development Scientist
AstraZeneca. Convert program strategy into study concept documents, protocols, informed consent forms, case report forms, and table/listing/figure shells .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in oncology drug development, including protocol design, regulatory compliance, and clinical monitoring. Proven ability to lead cross-functional teams and mentor clinical staff while ensuring adherence to Good Clinical Practice (GCP) and regulatory standards.
Highest-signal resume keywords
Oncology ExperienceClinical Development PlansGood Clinical Practice (GCP)Medical MonitoringRegulatory Approval Processes
ATS Keywords
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Hard Skills
Protocol DesignClinical Study ReportsFeasibility QuestionnairesData Review and InterpretationNDA/BLA Registration PackagesAdaptive Trial DesignsBiomarkersAnalytical ApproachesClinical InputGovernance Approvals
Soft Skills
Strong Communication SkillsPresentation SkillsMentoringInfluencingConsensus Building
Certifications & Qualifications
PharmDPh.D. in Life SciencesMD
Industry Keywords
FDA RegulationsGood Clinical Practice (GCP)Clinical ResearchPharmaceutical IndustryR&D OperationsOncology TherapeuticsClinical MonitoringGlobal Matrix TeamsHealth Authority InteractionsClinical Trials
Tech Stack
Tools & technologiesGo
About the role
Key responsibilities & impact- Convert program strategy into study concept documents, protocols, informed consent forms, case report forms, and table/listing/figure shells
- Ensure study materials align with clinical practice, scientific and regulatory developments, and program objectives
- 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
- Lead or approve the Medical Oversight Plan as appropriate
- 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 as appropriate
- Lead high-level clinical data reviews and interpretation
- Develop content for governance interactions seeking 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 strategies
- Contribute to advisory boards and deliver investigator and monitor training
- Represent Clinical Development as a core GST member
- Integrate input from global medical affairs, marketing companies, commercial, and other stakeholders
- Lead or provide expert input to process improvements and cross-asset or cross-tumor working groups
- Mentor and develop less experienced team members and provide line management as appropriate
Requirements
What you’ll need- 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, related documents, methodologies, analysis plans, and evaluation tools
- Ability to drive 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 for internal governance committees and external audiences
- 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 and shaping team performance
- Ability to influence and build consensus across operations, biostatistics, regulatory, safety, and commercial stakeholders
- Advanced oncology therapeutic area expertise across multiple tumor types
Benefits
Comp & perks- Eligibility for short-term incentive bonuses
- Equity-based awards for salaried roles
- Qualified retirement programs
- Paid time off, including vacation, holiday, and leaves
- Health coverage
- Dental coverage
- Vision coverage
- Flexible working arrangements while working an average minimum of three days per week from the office