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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical development, particularly in oncology, with a strong focus on protocol development, regulatory submissions, and data analysis. Proven ability to collaborate within cross-functional teams and drive scientific quality and compliance throughout the study lifecycle.
Highest-signal resume keywords
Clinical Development ExperienceOncology Clinical DevelopmentProtocol AuthoringRegulatory SubmissionsCross-Functional Collaboration
ATS Keywords
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Hard Skills
Protocol DevelopmentData ReviewClinical Study ReportsBenefit–Risk AssessmentGCP ComplianceICH GuidelinesClinical Study ProposalsData InterpretationRegulatory ComplianceStudy Design
Soft Skills
Scientific LeadershipCommunicationCollaborationProblem-SolvingRisk Identification
Industry Keywords
Pharmaceutical IndustryBiotechnologyOncologyClinical Matrix TeamHealth Authority ResponsesIND SubmissionsEoP2NDA/MAAAdCom SubmissionsClinical Operations
Tech Stack
Tools & technologiesGoogle Cloud PlatformGo
About the role
Key responsibilities & impact- Provide scientific leadership across study-level protocol development, study design, data review, and interpretation
- Serve as a core member of the Clinical Matrix Team
- Advise the Clinical Development Lead and Senior Scientist on asset-level strategy, benefit–risk assessment, and programme decisions
- Ensure scientific quality and consistency of protocols, Investigator’s Brochures, Clinical Study Reports, and submission materials
- Analyse and interpret clinical data on safety, efficacy, and patient populations
- Integrate internal and external data, literature, competitor data, and emerging science
- Support study conduct, scientific inquiries, data integrity, protocol implementation, and regulatory compliance
- Author or co-author clinical study proposals and support Protocol Review Board presentations
- Present study rationale and design at Investigator Meetings
- Support study-level Go/No-Go criteria
- Provide input to regulatory submissions, Health Authority responses, DSURs, and INDSRs
- Collaborate with Clinical Operations, Statistics, Safety, Regulatory, Medical Affairs, investigators, external experts, advisory boards, and collaborators
- Contribute to publications, congress presentations, and study-related materials
- Identify study-level risks and contribute to mitigation strategies
- Drive consistent ways of working and process improvements across the programme
- Participate in Oncology Clinical Development initiatives and capability-building workstreams
Requirements
What you’ll need- Bachelor’s degree in life sciences or related scientific discipline required
- 5+ years of experience in the pharmaceutical/biotechnology industry or related clinical development, focused on oncology
- Experience in clinical development from early stage through regulatory submission, including study design, protocol authoring, and data review/interpretation
- Experience working within GCP, ICH, and global regulatory guidelines
- Experience authoring or contributing to clinical study proposals, protocols, Investigator’s Brochures, informed consent forms, clinical study reports, and regulatory submissions
- Experience working within cross-functional matrix teams and contributing to clinical decision-making
- Proven track record working with investigators, site staff, external experts, CROs, and vendors
- Advanced degree in life sciences or related discipline strongly preferred
- Clinical development experience across multiple phases of development (Phase I–IV)
- Oncology or immuno-oncology clinical development experience
- Experience presenting or preparing materials for Protocol Review Boards, governance meetings, or scientific forums
- Knowledge of regulatory requirements supporting registration, including IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, or AdCom submissions
Benefits
Comp & perks- Annual bonus
- Eligibility to participate in share-based long-term incentive program
- Health care and other insurance benefits for employee and family
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver, parental, and medical leave
- Hybrid work with remote work available on non-on-site days
- Accommodation or other assistance to apply, if required