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Exelixis

Clinical Development Medical Director (Biotechnology / Oncology)

RemoteUnited States only
Published
Experience
Senior
Employment
Full-time
Company size
Enterprise
$254.5k–$361k/yr
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Open to US only. Set where you work from to check your eligibility.

No BS summary

MD-level physician with ≥5 years post-residency and hands-on oncology clinical-trials experience. Lead design/medical monitoring of early/late-stage oncology trials, safety reporting, and regulatory clinical reporting. Remote within US-pay geography (US benefits/401k) and background in drug development in biotech/pharma preferred.

Core skills

clinical trial designmedical monitoring

Required skills

MDadverse event reportingGCPgood medical practiceregulatory reportingclinical data analysis

Optional skills

board certification in Oncology or Hematology/Oncologymolecular targeted therapies experienceimmunological therapies experiencedrug development in biotechnology or pharmaceutical industry

What you'll do

  • 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.
  • 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.
  • May recruit clinical investigators for research studies.
  • Monitor adherence to protocols and determine study completion.
  • Adverse event reporting and safety monitoring.

What they require

  • MD required with a minimum of 5 years of post-residency experience.
  • Board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential.
  • Hands-on experience in the design, execution, and reporting of controlled clinical trials in oncology.
  • Participated in clinical oncology studies with molecular targeted or immunological therapies.
  • Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).
  • Drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry.
  • Proven ability to effectively work in a cross-functional/matrix environment.
  • Strong interpersonal, influencing, presentation, and written and verbal communication skills.
  • Strong organizational and time management skills.

Benefits

  • 401k plan with generous company contributions
  • group medical, dental and vision coverage
  • life and disability insurance
  • flexible spending accounts
  • discretionary annual bonus program
  • opportunity to purchase company stock and receive long-term incentives
  • 15 accrued vacation days in first year
  • 17 paid holidays including company-wide winter shutdown
  • up to 10 sick days per calendar year
  • reasonable accommodation email for applicants with disabilities (recruiting@exelixis.com)
PharmaceuticalsEnterprise
$254.5k–$361k/yr