Clinical Development Medical Director (Oncology/Biotechnology)
Exelixis
9 hours ago
On-site
Alameda, CA
$254,500 - $361,000 USD yearly
Clinical Research and Development
Responsibilities:
- Lead and execute early/late stage clinical trials for oncology products in development.
- Participate in design/planning of clinical studies and interpret study results.
- Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems, and final reports.
- Design, prepare, and initiate study protocols and 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 groups to analyze and report safety data.
- Analyze and interpret clinical trial data; prepare reports for regulatory agencies and publications.
- Interact with key opinion leaders and investigators in relevant disease areas.
- Ensure consistency of scientific and development strategies for oncology products in development.
- Maintain high-level scientific/clinical knowledge in relevant disease area.
- Monitor adherence to protocols and determine study completion.
Qualifications:
- MD required (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential) with at least 5 years post-residency experience.
- Equivalent combination of education and experience.
- Drug development experience in biotechnology/pharmaceutical industry (academia+industry experience acceptable).
- Hands-on experience designing, executing, and reporting controlled clinical trials in oncology.
- Participation in 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 work effectively in cross-functional/matrix environments.
- Strong organizational and time management skills.
- Strong interpersonal, influencing, presentation, and written/verbal communication skills.
- Ability to develop and maintain relationships with key opinion leaders.
- Ability to develop technical/business solutions to complex problems; identify and implement methods/criteria to achieve results.
- Exercises independent judgment in methods, techniques, and evaluation criteria.
Benefits (as stated):
- 401(k) with generous company contributions; medical, dental, vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales).
- Company stock purchase; long-term incentives.
- 15 vacation days in first year; 17 paid holidays including winter shutdown in December; up to 10 sick days.
- Lead and execute early/late stage clinical trials for oncology products in development.
- Participate in design/planning of clinical studies and interpret study results.
- Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems, and final reports.
- Design, prepare, and initiate study protocols and 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 groups to analyze and report safety data.
- Analyze and interpret clinical trial data; prepare reports for regulatory agencies and publications.
- Interact with key opinion leaders and investigators in relevant disease areas.
- Ensure consistency of scientific and development strategies for oncology products in development.
- Maintain high-level scientific/clinical knowledge in relevant disease area.
- Monitor adherence to protocols and determine study completion.
Qualifications:
- MD required (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential) with at least 5 years post-residency experience.
- Equivalent combination of education and experience.
- Drug development experience in biotechnology/pharmaceutical industry (academia+industry experience acceptable).
- Hands-on experience designing, executing, and reporting controlled clinical trials in oncology.
- Participation in 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 work effectively in cross-functional/matrix environments.
- Strong organizational and time management skills.
- Strong interpersonal, influencing, presentation, and written/verbal communication skills.
- Ability to develop and maintain relationships with key opinion leaders.
- Ability to develop technical/business solutions to complex problems; identify and implement methods/criteria to achieve results.
- Exercises independent judgment in methods, techniques, and evaluation criteria.
Benefits (as stated):
- 401(k) with generous company contributions; medical, dental, vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales).
- Company stock purchase; long-term incentives.
- 15 vacation days in first year; 17 paid holidays including winter shutdown in December; up to 10 sick days.