Chief Medical Officer Job Responsibilities: 1. Provide strategic direction for clinical programs. 2. Interact and make presentations to the Board of Directors. 3. Prepare clinical development plans for the development of company’s products. 4. Oversee all medical components of the drug development process. 5. Act as Medical Monitor for ongoing studies including review of SAEs and other safety data: answers site questions on inclusion/exclusion criteria or other protocol questions, evaluates and assesses SAEs and AEs, reviews laboratory and other safety parameters, reviews patient profiles, reviews coded terms for medical history, concomitant medications, adverse events, and provides medical expertise to project teams during life-cycle of study. 6. Be an integral part of the clinical operations team to ensure successful clinical trials- Supports study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material. 7. Interpret, summarize and convey information from clinical studies. 8. Participate in the preparation of FDA submissions and meetings. 9. Be knowledgeable about industry specific regulatory practices and procedures. 10. Participate in investigator and advisory board meetings as requested. 11. Provides therapeutic training relevant to specific study to the project team. 12. Contributes to discussions with health authorities, Ethics Committees, investigators, opinion leaders, internal and external clients. 13. Provides benefit/risk evaluations and drug safety expertise for drugs, diagnostics, and devices in development and during market authorization. 14. Reviews and interprets study results and clinical study reports. 15. Generates expert reports and supports IAS/IAEs, NDAs/PLAs, and other regulatory submissions, as well as generates and/or reviews publications, posters, and scientific presentations. 16. Identify and interact with key opinion leaders, investigators and investors. Job Requirements: 1. M.D., with drug development experience in oncology immunotherapeutic areas. Board Certified Preferred. 2. With minimum of 5-8+ years’ clinical drug development experience in a pharmaceutical or Biotech environment. 3. Solid drug development background with experience in filing IND’s and bringing novel therapeutics into clinical development. 4. Experience in the design and execution of clinical trials used to demonstrate safety and efficacy. 5. Effective communicator with strong written and verbal communication skills. 6. Understanding of clinical trial operations, biostatistics and data management techniques. 7. Good understanding of clinical pharmacology principles. Work site: US
Chief Medical Officer Job Responsibilities: 1. Provide strategic direction for clinical programs. 2. Interact and make presentations to the Board of Directors. 3. Prepare clinical development plans for the development of company’s products. 4. Oversee all medical components of the drug development process. 5. Act as Medical Monitor for ongoing studies including review of SAEs and other safety data: answers site questions on inclusion/exclusion criteria or other protocol questions, evaluates and assesses SAEs and AEs, reviews laboratory and other safety parameters, reviews patient profiles, reviews coded terms for medical history, concomitant medications, adverse events, and provides medical expertise to project teams during life-cycle of study. 6. Be an integral part of the clinical operations team to ensure successful clinical trials- Supports study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material. 7. Interpret, summarize and convey information from clinical studies. 8. Participate in the preparation of FDA submissions and meetings. 9. Be knowledgeable about industry specific regulatory practices and procedures. 10. Participate in investigator and advisory board meetings as requested. 11. Provides therapeutic training relevant to specific study to the project team. 12. Contributes to discussions with health authorities, Ethics Committees, investigators, opinion leaders, internal and external clients. 13. Provides benefit/risk evaluations and drug safety expertise for drugs, diagnostics, and devices in development and during market authorization. 14. Reviews and interprets study results and clinical study reports. 15. Generates expert reports and supports IAS/IAEs, NDAs/PLAs, and other regulatory submissions, as well as generates and/or reviews publications, posters, and scientific presentations. 16. Identify and interact with key opinion leaders, investigators and investors. Job Requirements: 1. M.D., with drug development experience in oncology immunotherapeutic areas. Board Certified Preferred. 2. With minimum of 5-8+ years’ clinical drug development experience in a pharmaceutical or Biotech environment. 3. Solid drug development background with experience in filing IND’s and bringing novel therapeutics into clinical development. 4. Experience in the design and execution of clinical trials used to demonstrate safety and efficacy. 5. Effective communicator with strong written and verbal communication skills. 6. Understanding of clinical trial operations, biostatistics and data management techniques. 7. Good understanding of clinical pharmacology principles. Work site: US