Clinical Science Director
$195k - $277.5kExelixis Inc
Exelixis seeks a Clinical Science Director to design and develop oncology clinical studies in early and late phases. The role involves preparing clinical documentation, collaborating with internal teams and external investigators, and supporting regulatory submissions for investigational drug candidates.
Responsibilities
- Design, prepare, and initiate clinical study protocols and related documentation per regulatory requirements
- Engage with oncology investigators and thought leaders to develop study synopses and protocols
- Conduct literature research and assist in investigator selection for clinical studies
- Collaborate on development of informed consent forms, case report forms, and training materials
- Analyze study data and support preparation of regulatory filing documents and publications
Requirements
- Pharm.D., PhD, or M.D. with minimum 8 years related experience
- 5-8 years clinical development experience in biotech or pharmaceutical industry
- Experience with clinical oncology studies involving molecular targeted or immunological therapies
- Comprehensive knowledge of clinical trial design, execution, and drug development processes
- Strong analytical skills, business communication, and public speaking abilities
- Highly organized with ability to manage complex projects under tight timelines
Compensation: $195,000 - $277,500 base annually
$195k - $277.5k
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