Director/Senior Director, Clinical Science (Contractor)
Location: United States
Department: Clinical Development
Employment Type: Contract 

A clinical-stage precision medicine oncology organization is seeking an experienced, motivated, and outgoing Clinical Scientist to join its Clinical Development team. This new hire will work closely with the clinical leader, providing medical-scientific expertise to one or more clinical programs.

Responsibilities:

• Contribute to clinical development concepts and plans, primarily for early oncology development programs
• Draft or support drafting of protocol synopses, protocols, and protocol amendments
• Review and develop informed consent forms, including site-specific requests
• Collaborate with Clinical Operations on site selection, study start-up, and communication
• Author or update clinical sections of investigator brochures and lead annual updates
• Write/review clinical and safety sections of regulatory submissions (e.g., NDAs/MAAs)
• Represent the medical function on clinical study teams and serve on the clinical sub team
• Review and interpret clinical and safety data, including serious adverse events
• Contribute to or lead authoring of clinical study reports and publications
• Prepare clinical study or program-related slide decks for internal/external use
• Train colleagues, CROs, and site staff on therapeutic area knowledge and protocol content
• Participate in and organize advisory boards and thought leader interactions
• Conduct therapeutic area and competitive landscape research
• Build and maintain key opinion leader and investigator networks
• Support regulatory interactions, inspections, and audit responses
• Assist in regulatory updates and submissions
• Act as Medical Monitor for Phase 2 or 3 trials, supporting patient safety and clinical execution
• Present study results internally and externally, including conferences and publications
• Contribute to program-level activities, including clinical overviews, investigator brochures, risk management plans, and clinical labeling content

Qualifications:

• Bachelor's degree required; advanced degree in clinical oncology (e.g., MD, NP, PharmD, PhD, or Master’s) preferred
• Minimum 4 years of industry experience in oncology clinical development
• Prior participation in full-scope clinical development programs (start-up to reporting)
• Experience with small molecule clinical trials preferred
• Skilled in protocol design, medical monitoring, and adverse event assessment
• Knowledge of Good Clinical Practice (GCP)
• Ability to thrive in a fast-paced, dynamic environment
• Experience representing their function at the clinical lead level and collaborating across cross-functional teams