Senior Oncology Clinical Development Director

Exelixis Inc.; Alameda (CA); On-site; USD 318,000 - 402,000; Full time

Benefits offered by this job

401k

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Flexible Spending Accounts

Bonus program

Stock purchase plan

Vacation days

Paid holidays

Sick days

Job summary

Exelixis Inc. is seeking a senior clinical trials leader to oversee early and late-stage oncology studies. You will design protocols, monitor trials and collaborate with safety teams to ensure rigorous data quality and regulatory compliance.

Ideal candidates have 8+ years post-residency in drug development, with hands-on experience in oncology trial design, execution and reporting and interaction with KOLs. Strong leadership and communication skills are required.

Qualifications

• MD with board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential; minimum 8 years post-residency.
• Equivalent combination of education and experience in drug development is accepted.
• Hands-on experience in the design, execution, and reporting of controlled clinical trials in oncology.

Responsibilities

• Design, prepare and initiate study protocols and documentation in compliance with project plans, GCP and regulations.
• Act as medical monitor for company-sponsored trials.
• Support project teams with therapeutic area information.
• Collaborate with safety group in analyzing and reporting safety data.
• Analyze and interpret clinical trial data and prepare reports for regulatory agencies and publication.
• Interact with key opinion leaders and investigators in relevant disease areas.

Skills

Cross-functional teamwork

Medical monitoring

GCP compliance

Study design

Safety data analysis

Regulatory reporting

Education

MD degree

Board-eligible in Oncology/Hematology

Job description

Exelixis Inc. is seeking a senior clinical trials leader to oversee early and late-stage oncology studies. You will design protocols, monitor trials and collaborate with safety teams to ensure rigorous data quality and regulatory compliance.

Ideal candidates have 8+ years post-residency in drug development, with hands-on experience in oncology trial design, execution and reporting and interaction with KOLs. Strong leadership and communication skills are required.