Development Clinical Research Physician Neuroscience

Development Clinical Research Physician-Neuroscience
Our client, a global pharma company are currently recruiting for a Development Clinical Research Physician with expertise in Neuroscience. As Development Clinical Research Physician you will participate in the development, conduct, and reporting of corporate/global clinical trials in support of registration and commercialisation of Neuroscience products. This is a permanent role with hybrid working


Responsibilities

• Collaborate in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans, and study protocol design
• Contribute to the global alignment of clinical strategy and clinical plans
• Understand and keep updated with the pre-clinical and clinical data relevant to the molecule
• Plan collaborate on and review the scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (for example, annual reports) according to the agreed-upon project timeline
• Provides oversight and input into Inform Consent Documents
• Collaborate with clinical research staff in the design, conduct, and report of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions)
• Review and approve risk profiles to ensure appropriate communication of risk to study subjects
• Participate in investigator identification and selection, in conjunction with clinical teams
• Ensure that the operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements
• Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel
• Serve as a resource to clinical operations personnel/ clinical research monitors, investigators, and ethical review boards to address any questions or clarify issues arising during the conduct of the study
• Understand and actively address the scientific information needs of all investigators and personnel
• Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures
• Support/ assist in the preparation of regulatory reports, including NDAs, FDA annual reports, and Periodic Adverse Drug Experience reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective
• Participate in advisory committees
• Participate in risk management planning along with affiliates and Global Patient Safety (GPS)
• Critically read and evaluate the relevant medical literature; know the status and data from competitive products and keep updated with medical and other scientific developments relevant to the product
• Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near-term (1-2 years) and longer-term (3-5years)
• Responsible for the scientific training of the clinical study team
• Acts as scientific consultant and protocol expert for clinical study team members and others in medical
• Explore and take advantage of opportunities for extramural scientific experiences

• Medical Doctor
• Physicians must have completed education and training at a medical school that meets the requirements of the US Liaison Committee on Medical Education (LCME)
• US-trained physicians (Medical Doctors or Doctors of Osteopathy) must have achieved board eligibility or certification in Neuroscience
• 5 years of work experience in Neuroscience
• Minimum of 5 years of professional experience in pharmaceutical drug development with demonstrated experience and knowledge of clinical research and the drug development process
• Demonstrated knowledge of the drug development process
• Demonstrated strong communication, interpersonal, organizational, teamwork, and negotiation skills
• Demonstrated ability to influence others (both cross-functionally and within the function) to create a positive working environment
• Ability to engage in domestic and international travel to the degree appropriate to support the business of the team
• Clinical research or pharmaceutical medicine experience preferred
• Fluent in English, written and verbal communications
• Ability to engage in occasional domestic and international travel to the degree appropriate to support the business of the team
• Strong administrative and leadership skills