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Director, Clinical Science
LantheusDirector of Clinical Science managing clinical studies for a radiopharmaceutical company. Responsible for clinical development planning, oversight, and regulatory interactions.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical development planning and execution, with a strong focus on oncology and radiopharmaceuticals. Proficient in authoring study protocols and regulatory submissions while ensuring compliance with ICH/GCP guidelines.
Highest-signal resume keywords
Clinical Development ExperienceOncology Clinical DevelopmentRegulatory Guidelines KnowledgeStudy Protocol DevelopmentExcellent Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Study ExecutionData InterpretationClinical Data ReviewStudy Document AuthoringProtocol Design Preparation
Soft Skills
Verbal CommunicationWritten CommunicationCross-Functional Collaboration
Certifications & Qualifications
Advanced Degree (MD, PhD, PharmD)
Industry Keywords
Pharmaceutical IndustryClinical Development PhasesContract Research OrganizationsInvestigative SitesICH/GCP Compliance
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Responsible for the relevance and accuracy of clinical development planning and guidance for a clinical study.
- Contribute to authoring and lead design/reviews of key product and study-related documents and deliverables.
- Responsible for the oversight of clinical study execution as clinical lead.
- Works with investigative sites and/or study teams to answer protocol related questions.
- Reviews clinical data listings, patient profiles and summaries to ensure data collection, data interpretation and data reporting proceeds in a manner consistent with the protocol.
- Prepare and may present protocol designs, clinical data and other information at advisory boards, investigator meetings, site initiations and other internal and external settings.
- Supports regulatory interactions and the development of clinical sections for regulatory correspondence and submissions.
Requirements
What you’ll need- Advanced Degree preferred (e.g. MD, PhD, or PharmD).
- 7 - 10 years of relevant experience in pharmaceutical industry in clinical development preferred.
- Oncology and/or Radiopharmaceutical clinical development experience preferred.
- Clinical development experience across all phases of development (I - III).
- Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors.
- In-depth knowledge of regulatory guidelines and ICH/GCP.
- Experience in developing and writing study protocols, clinical study reports and other study documents.
- Excellent verbal and written communication skills with ability to work across functions in multifunctional matrix environment.
Benefits
Comp & perks- Comprehensive health benefits package including medical, prescription drug, dental, and vision coverage.
- Life and disability benefits.
- Pre-tax accounts.
- 401(k) with company contribution.
- Generous time off package including paid vacation, holidays, sick days, and paid parental leave.