Senior Medical Director, Oncology Clinical Development

Exelixis; United States; On-site; USD 313,000 - 444,000; Full time

Benefits offered by this job

401k plan with generous contributions

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock purchase program and long-termin

Job summary

Exelixis seeks a Senior Medical Director to lead and execute early and late-stage oncology trials. You will design protocols, monitor safety, and coordinate submissions to the FDA.

You will collaborate with clinical teams, investigators and KOLs to maintain rigorous scientific standards across development programs. The role requires MD with 8+ years in drug development; hands-on trial design, monitoring, and reporting experience in oncology.

Qualifications

• MD (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential) and a minimum of 8 years post-residency relevant experience; or,

Responsibilities

• Support the establishment of clinical trial strategies for oncology products in development.
• Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
• Act as medical monitor for company sponsored trials (including but not limited to assessment of eligibility and safety events requiring study drug dose modification; data review; protocol writing; presentation at investigator meetings, steering committee meetings, DMC reviews; contributing to clinical study reports; publication review).
• Support project teams with therapeutic area specific information.
• Collaborate with internal safety group in analyzing and reporting of safety data from clinical trials.
• Analyze and interpret other clinical trial data and prepare reports for regulatory agencies and publication.
• Interact with key opinion leaders and investigators in relevant disease specific area.
• Ensure consistency of scientific and development strategies for oncology products in development.
• Maintain the highest level of scientific and clinical knowledge in relevant disease specific area.

Skills

Cross-functional environment

Broad expertise

Solutions to complex problems

Methods/evaluation criteria

Lead or manage others

Key opinion leaders relations

Interpersonal/presentation skills

Organizational/timemanagement skills

Education

MD

Education/Experience equivalence

Job description

Exelixis seeks a Senior Medical Director to lead and execute early and late-stage oncology trials. You will design protocols, monitor safety, and coordinate submissions to the FDA.

You will collaborate with clinical teams, investigators and KOLs to maintain rigorous scientific standards across development programs. The role requires MD with 8+ years in drug development; hands-on trial design, monitoring, and reporting experience in oncology.