Senior Director, Clinical Research (Oncology)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Senior Director, Clinical Research (Oncology): Leading the scientific and functional implementation of clinical development plans for novel oncology therapeutics with an accent on Phase 3 pivotal study design and FDA regulatory interactions. Focus on overseeing data integrity, authoring clinical documents, and driving the execution of pivotal clinical trials to improve cancer patient survival.
Location: Remote (Any US State)
Salary: $290,000 – $300,000 per year
Company
is a biopharmaceutical company developing novel therapeutic candidates to significantly improve the practice of oncology and patient survival.
What you will do
- Develop and support clinical scientific strategies within the Clinical Development Plan (CDP).
- Design, execute, and analyze clinical studies for oncology product candidates.
- Provide scientific oversight and ensure data integrity and quality for assigned clinical trials.
- Author and review clinical documents, including protocols, amendments, and informed consents.
- Manage relationships with external clinical research partners and vendors to support drug development.
- Represent the company in external scientific, medical, and regulatory forums.
Requirements
- Advanced Degree in life sciences (Medicine, Pharmacy, Biology, etc.).
- 10+ years of experience in clinical research/development, specifically in Oncology Phase 3/pivotal space.
- Proven experience with FDA regulatory interactions and pivotal study conduct.
- Expert knowledge of ICH/GCP and all aspects of clinical study design and statistics.
- Demonstrated ability to lead project strategies and manage teams in a matrix environment.
- Must be based in the United States.
Culture & Benefits
- Competitive base salary, performance-based bonuses, and equity plans.
- Unlimited vacation and 10 sick days annually.
- Comprehensive medical, dental, and vision coverage.
- 401K plan with company matching.
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