Medical Oncology Director

Job Description

Agile Clinical is actively recruiting for a Senior Medical Director to support the creation of new cancer therapies utilizing targeted radioligands.    

This is a Direct Hire, Remote opportunity. Candidate must be able to travel for team and client meetings within the U.S. and Canada.  

Candidate must be an MD (Board Certified or Eligible,) with oncology practice experience, outside of education.  Must have industry experience with complex trial design knowledg, thorough understanding of oncology drug development and approval processes and radiopharmaceutical experience. 

Reporting to the EVP of Clinical Development, the Senior Medical Director is a leadership role within Clinical Development offering strategic input into early and late stages of development plans, study designs, publication strategies, safety monitoring and product labeling. The role will provide leadership on translational and clinical research decisions in partnerships with translational and biomarker research scientists, clinical pharmacologists, Medical Monitors, Investigators, Key Opinion Leaders, Biostatisticians and the study team. The role will be a key stakeholder at Health Authority engagements and cross-functional team discussions, including Regulatory, Clinical Operations, Biostatistics, CMC, Safety and at the Executive Level.

• Strategize and implement innovative early (First-in-Human)/Proof of Concept and late (registrational) clinical development programs including clinical protocol design and overall development strategy
• Contributes to the design, development and interpretation of PK/PD studies that best characterize key compound attributes
• Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development
• Therapeutic leader for study team
• Assist in the preparation and review of INDs, investigator brochures, protocols, informed consent forms, and clinical study reports.
• Provide medical oversight of clinical trials and serve as Medical Monitor on designated trials or oversee assigned Medical Monitors
• Provide leadership on disease state training and medical expertise including the presentation of product background and clinical trial results
• Collaborate with biostatistics to establish sample size scenarios, statistical analysis plans and other study deliverables
• Lead publication plans and provide scientific and medical contributions to publications and presentations
• Contribute to clinical documents within INDs/CTAs as well as NDAs/NDSs with strategic positioning of data, document review and writing.
• Oversee clinical data review, trends and interpretation.
• Contribute to regulatory activities, such as Briefing Document preparation, FDA interactions and Information Requests.
• Contribute to and/or lead advisory boards, data safety monitoring boards and key opinion leader discussions.
• Align departmental activities in support of corporate goals, as appropriate.
• Manage and mentor clinical staff

Requirements

• MD (or MD/PhD) with board eligibility or accreditation, preferably in Medical Oncology, Nuclear medicine, or Radiology
• Minimum 10 years’ experience in clinical research with at least 5 years in Industry
• Minimum of 8 years’ experience in the biotech or pharmaceutical industry with at least 3 years’ experience managing direct reports
• 25% travel is required within North America
• Thorough understanding of oncology drug development and approval processes
• Knowledge of clinical pharmacology and its relationship to decision-making in early drug development.
• Demonstrated success in translational and clinical study design, FDA discussions and data analysis
• Experience with design, execution and analysis of Phase 1-3 clinical studies preferred.
• Experience in theranostic development preferred
• Technical understanding of eCTD submission requirements, the CFR, GCP/ICH.
• Excellent interpersonal, communication and presentation skills
• Ability to manage multiple projects and shifting priorities

Competencies

• Demonstrates leadership, flexibility, critical thinking, time management and problem-solving skills.
• Proficiency in Excel, Word, and PowerPoint (required)
• Ability to understand new scientific concepts and information and apply these in a changing environment
• Inherent drive to cultivate collaboration, teamwork and professionalism
• Organized with high attention to detail, accuracy and completeness
• Demonstrates excelled organizational, problem solving and communication skills