Medical Director

Role Summary:

Essential Duties and Responsibilities

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• Accountable for providing medical, scientific, and strategic insights, in collaboration with cross-functional team members.
• Assume medical monitoring responsibility for clinical trials (Phase 1-3), including patient eligibility assessment, study design questions and routine medical data review, including trend review and assessment for safety signals and assisting with coding review and data cleaning. 
• Trend review and assessment of safety signals will include awareness of AESIs, SAEs, and participating in aggregate review and adjudication of the safety database
• Participate in responding to the Health Authorities questions.
• Participate in designing and developing clinical studies. Participate in the identification and selection of appropriate external investigators and sites. Attend and present at Investigator meetings
• Medical expert for clinical documents and contributes to the generation of investigator brochures, protocols and informed consents, and clinical study reports and regulatory filings including authoring clinical sections for INDs, NDAs, and other related documents.
• Final listing review, review of blinded TLF, review protocol deviations, participate in all data base lock meetings)
• Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
• Conducts medical review and interpretation of efficacy and safety data from clinical trials; this may include delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting
• Ensures the medical and scientific validity of clinical study report, especially conclusions regarding efficacy and safety
• Stays abreast of internal and external developments, trends and other dynamics, to maintain a fully current perspective of internal/external influences and/or implications for the conduct of oncology clinical trials and the assigned therapeutic area(s)
• Develops and maintains relationships with our investigators, scientists, thought leaders and partner organizations. Interacts and facilitates relationships with external societies, advocacy groups, and alliance partner engagements. 
• Participates in the development and implementation of project-related communications, including education of investigators, study site personnel, and study staff, advisory boards, regulatory meetings, major medical congresses, and publication of clinical study results in high quality scientific or medical journals.
• Work in close collaboration with translational medicine to ensure alignment of translational, biomarker, and companion diagnostic development milestones with clinical trial objectives through registration. 
• Provide clinical science development guidance regarding early development/Phase I studies or relevant acquisitions, joint ventures, or other strategic partnerships. 
• Travel (including international) up to 20% time, based upon program needs.

Education and/or Work Experience Requirements: 

• MD, MD/PhD (BC/BE in Oncology, Hematology, Hematology/Oncology, or related specialty) with an advanced and current understanding of cancer biology and disease processes.
• Neuro-Oncology experience preferred
• At least 2 years of experience as a physician in oncology clinical development support, on oncology studies or 5 years of academic experience, including serving as an investigator on clinical trials.
• Experienced in the conduct of clinical trials (investigator initiated, company sponsored or cooperative group trials), including designing, executing and interpreting data and their subsequent publications. 
• Demonstrated understanding of clinical tumor biology, and the ability to apply that knowledge to drug development. 
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, as well as overall understanding and knowledge of NDA filing requirements.
• Possesses the ability to critically evaluate medical/scientific information 
• Ability to think strategically and creatively. Strong track record of enjoying the details without losing sight of the larger goals. Ability to multi-task and handle multiple projects simultaneously. 
• Excellent technical writing, oral, presentation, and interpersonal communication skills and ability to present concepts and results in a clear and concise manner. 
• Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.

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