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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading and executing clinical trials for oncology products, with a strong focus on protocol design, data analysis, and regulatory compliance. Possesses extensive knowledge in drug development and the ability to collaborate effectively with cross-functional teams and key opinion leaders.
Highest-signal resume keywords
Clinical Trial ManagementOncology Drug DevelopmentMedical MonitoringRegulatory SubmissionsCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Protocol DesignData Collection SystemsAdverse Event ReportingSafety Event MonitoringClinical Data AnalysisStudy Protocol PreparationMolecular BiologyImmunologyBiochemistryClinical Study Reporting
Soft Skills
Interpersonal SkillsOrganizational SkillsTime ManagementInfluencing SkillsPresentation Skills
Certifications & Qualifications
MDBoard Certification in OncologyBoard Certification in Hematology/Oncology
Industry Keywords
Clinical TrialsFDA SubmissionsGood Clinical PracticeBiotechnologyPharmaceutical IndustryMolecular Targeted TherapiesImmunological TherapiesKey Opinion LeadersCross-Functional TeamsDrug Development
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead and execute early and/or late stage clinical trials for oncology products in development
- Participate in the design and planning of clinical studies and interpret study results
- Establish and approve scientific methods for clinical protocol design, data collection systems and final reports
- Recruit clinical investigators for research studies as needed
- Conduct adverse event reporting and safety event monitoring
- Coordinate and develop reporting information for FDA submissions
- Monitor protocol adherence and determine study completion
- Support clinical trial strategies for oncology products
- 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, including eligibility and safety-event assessment, data review, protocol writing, investigator and committee presentations, DMC reviews, clinical study reports and publication review
- Support project teams with therapeutic-area-specific information
- Collaborate with the internal safety group to analyze and report clinical-trial 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-specific areas
- Ensure consistency of scientific and development strategies
- Maintain the highest level of scientific and clinical knowledge in the relevant disease-specific area
- Directly supervise employees
Requirements
What you’ll need- MD and a minimum of 8 years post-residency relevant experience, or equivalent combination of education and experience
- Board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential
- Minimum of eight years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry
- Hands-on experience in the design, execution, medical monitoring, and reporting of controlled clinical trials in oncology
- Participation in clinical oncology studies with molecular targeted or immunological therapies
- Understanding of basic science relevant to clinical oncology, including biochemistry, immunology, molecular biology and/or genetics
- Ability to work effectively in a cross-functional/matrix environment
- Broad expertise or unique knowledge and skills supporting company objectives
- Ability to develop technical and/or business solutions to complex problems
- Ability to identify and implement methods, techniques, procedures and evaluation criteria
- Experience leading or managing the work of others
- Ability to develop and maintain relationships with key opinion leaders
- Strong written and verbal interpersonal, influencing, and presentation skills
- Strong organizational and time management skills
Benefits
Comp & perks- 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
- Long-term incentives
- 15 accrued vacation days in the first year
- 17 paid holidays including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year
- Necessary equipment, including dual monitors and ergonomic chairs
