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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, including protocol authoring, data interpretation, and regulatory submissions, with a strong focus on oncology. Proven ability to collaborate within cross-functional teams and provide scientific leadership throughout the study lifecycle.
Highest-signal resume keywords
Clinical Development ExperienceProtocol AuthoringRegulatory SubmissionsOncology ExpertiseCross-Functional Collaboration
ATS Keywords
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Hard Skills
Data ReviewStudy DesignClinical Study ReportsBenefit–Risk AssessmentGCP ComplianceICH GuidelinesClinical ProtocolsInformed Consent FormsIND SubmissionsEfficacy Analysis
Soft Skills
Scientific LeadershipCommunication SkillsProblem-SolvingCollaborationPresentation Skills
Industry Keywords
Pharmaceutical IndustryBiotechnologyOncologyClinical Matrix TeamHealth Authority ResponsesCRO CollaborationPhase I–IV DevelopmentScientific AdviceAdCom SubmissionsGovernance Meetings
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
- Provide scientific insight to the Clinical Development Lead and Senior Scientist for asset-level strategy, benefit–risk assessment, and programme decision-making
- 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, including literature, competitor data, and emerging science
- Support study conduct, address scientific questions, and maintain data integrity and regulatory alignment
- Present study rationale and design at Investigator Meetings and respond to study-site scientific inquiries
- Support study-level Go/No-Go criteria implementation
- Support 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 scientific and operational risks and provide mitigation input
- 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
- Experience in pharmaceutical/biotechnology industry or related clinical development experience, with a focus 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 of working with investigators, site staff, external experts, CROs, and vendors
- Advanced degree (e.g. MS, PhD, PharmD) strongly preferred
- Clinical development experience across multiple phases of development (Phase I–IV) preferred
- GYN Oncology clinical development experience preferred
- Experience presenting or preparing materials for Protocol Review Boards, governance meetings, or scientific forums preferred
- Knowledge of regulatory requirements supporting registration, including IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, or AdCom submissions preferred
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 arrangement with remote work available on non-office days
- Accommodation or other assistance to apply, if required