Clinical Development, Design and Implementation of Clinical TrialsClinical Development Design And Implementation Of Clinical Trials
Location
South san francisco, CA
Job Type
Full-time
Job Description
Our client is a leading biopharmaceutical organization specializing in innovative immuno-oncology therapies. They are dedicated to transforming cancer treatment through groundbreaking research and development.
We are seeking a highly skilled and experienced Clinical Development Head to lead our immuno-oncology clinical development programs. The ideal candidate will have a deep understanding of oncology drug development, particularly in the field of immuno-oncology, and a proven track record of successfully advancing clinical programs from early-stage development through to regulatory approval.
Responsibilities
Lead the strategic planning and execution of clinical development programs for immuno-oncology therapies.
Provide clinical development expertise to cross-functional teams, including Clinical Operations, Regulatory Affairs, and Medical Affairs.
Drive the design and implementation of clinical trials, ensuring compliance with regulatory requirements and industry standards.
Analyze and interpret clinical data, and collaborate with internal and external stakeholders to develop evidence-based recommendations.
Manage relationships with key opinion leaders, clinical investigators, and external partners to advance clinical programs.
Contribute to the development of regulatory submission documents, including INDs, BLAs, and other regulatory filings.
Qualifications
MD or MD PhD with board certification or eligibility in Oncology, hematology/Oncology, or a related specialty is required.
Minimum 10 years clinical research experience in Oncology Clinical Development within a biotechnology and/or pharmaceutical company.
Demonstrated leadership overseeing development programs with multiple assets across solid and hematologic indications.
Expertise in the design, execution, and reporting of late-stage clinical trials in Oncology with small and/or large molecule drug candidates.
Proven track record of successful leadership in clinical development, with a focus on immuno-oncology.
Excellent communication, collaboration, and leadership skills.
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