Clinical Development Medical Director (Oncology/Biotechnology)
Exelixis · Alameda, CA · 1 wk ago
On-siteHealthcare$255k–$361k/yrFull-time
Responsibilities
- 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.
- Maintain the highest level of scientific and clinical knowledge in relevant disease specific area.
Qualifications
- MD (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential) required with a minimum of 5 years of post-residency experience.
- Experience/The Ideal For Successful Entry Into Job: Drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry.
- 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).
Skills
- Proven ability to effectively work in a cross-functional/matrix environment.
- Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
- Develops technical and/or business solutions to complex problems.
- Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
- Ability to develop and maintain relationships with significant key opinion leaders.
- Strong interpersonal, influencing, presentation, and written and verbal communication skills.
- Strong organizational and time management skills.
Pay
The base pay range for this position is $254,500 - $361,000 annually. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.