Legend Biotech US
Executive Director, Pipeline Clinical Lead
Somerset, New Jersey, United States · Director
Sponsorship not specified$15k-$20kDetected 26 days ago
GCPBusiness DevelopmentClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceResearchExperimental DesignAnimal StudiesLeadershipCommunicationCollaborationMentoringBiostatisticsRegulatory Affairs
About the role
- This role requires strong scientific judgment, leadership presence, and a hands on approach in a fast paced, entrepreneurial environment, with a clear focus on patient safety and clinical impact.
Responsibilities
- Serve as clinical science lead for early stage programs (pre IND through Phase 1/2), including study design, execution, data interpretation, and reporting.
- Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Early Discovery,
- Collaborate with external development partners, academic investigators, KOLs, and study sites.
- Lead effectively in a matrix environment, anticipating cross functional needs and proactively resolving conflicts or risks.
Requirements
- ≥8 years of clinical development experience in industry and/or academia, with demonstrated leadership in hematology/oncology.
- Proven experience designing and executing clinical trials from first in human through registrational stages.
- Cell therapy and/or CAR T clinical development experience highly desirable IT Skills.
- Strong scientific judgment with the ability to navigate complex clinical and regulatory challenges.
- Highly collaborative, influential leader with the ability to represent programs with credibility and confidence.
- Contribute clinical leadership to business development, due diligence, and partnership activities when required.
Nice to have
- Prior involvement with IND submissions
Compensation
- The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting.
Benefits
- Lead or support IND preparation and amendments, clinical sections of regulatory submissions, and responses to health authority questions.
- Champion patient safety, ethical conduct, and compliance with GCP, corporate policies, and global healthcare regulations.
- Provide direct line management and mentorship for Medical Directors, Clinical Research Scientists, Medical Writing, Clinical Program management and other clinical staff as applicable.
- Performance-based bonus and/or equity is available to employees in eligible roles.
- Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
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