Director, Oncology Clinical Science — Lead Trial Design

Exelixis; United States; Vor Ort; USD 195.000 - 278.000; Vollzeit

Benefits dieser Stelle

401k

Medical/Dental/Vision

Life Insurance

Disability Insurance

Flexible spending accounts

Annual bonus

Stock purchase plan

Paid vacation

Paid holidays

Sick days

Zusammenfassung

Exelixis seeks a Clinical Science Director to design and oversee oncology studies across early and late phases, prepare study synopses and protocols, and summarize results for publications and regulatory submissions.

The role collaborates with clinical teams, investigators, and medical monitors, ensuring GCP compliance, data integrity, and impactful presentations to external stakeholders. Strong publication and public speaking skills are essential.

Qualifikationen

• Pharm.D., PhD, or M.D. with at least 8 years in clinical development.
• Experience in oncology and regulatory documentation.
• Background in designing and managing phase I–IV studies.

Aufgaben

• Designs, prepares and initiates study protocols and documentation in compliance with project plans, GCP and good practice.
• Interacts with investigators and thought leaders to design synopses and protocols.
• Develops Informed Consent Forms, Case Report Forms, and CRF instructions with study teams.
• Contributes to safety reviews and data interpretation for regulatory filings and publications.
• Delivers high quality scientific presentations to physicians and external customers.
• Provides clinical education support for internal Exelixis customers.

Kenntnisse

Clinical development

Oncology

Scientific communication

Leadership

Ausbildung

Pharm.D./PhD/MD + 8 years experience

Jobbeschreibung

Exelixis seeks a Clinical Science Director to design and oversee oncology studies across early and late phases, prepare study synopses and protocols, and summarize results for publications and regulatory submissions.

The role collaborates with clinical teams, investigators, and medical monitors, ensuring GCP compliance, data integrity, and impactful presentations to external stakeholders. Strong publication and public speaking skills are essential.