CLINICAL RESEARCH SCIENTIST – IMMUNOLOGY TECH LEAD

Location: Cork, Ireland

Requirement: EU/UK Passport or Irish Stamp 4

Through the application of scientific training and clinical training and expertise, the Development clinical research scientist participates in: the development, conduct, and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety.

Clinical Planning:

• Collaborate with 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.

Clinical Research/Trial Execution and Support:

• Plans to collaborate on and review the scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed-upon project timeline.
• Provide protocol oversight and input into informed consent documents.
• Supports the monitoring of patient safety during the study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
• Review and collaborates with Development Medical Director on the approval of 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/ 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.
• Review lIT proposals and publications, as requested

Scientific Data Dissemination/Exchange:

• Knowledge of and compliance with local laws and regulations, global policies and procedures, compliance guidelines concerning data dissemination, and interactions with external healthcare professionals.
• Understand and address the unsolicited scientific information needs of external healthcare professionals according to the guidelines above.
• Participate in reporting clinical trial data in Clinical Trial Registry activities.
• Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
• Prepare or review scientific information in response to customer questions or media requests
• Provide telephone follow-up or specific written information requested by healthcare professionals as per global SOPs.
• Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis.
• Support medical information associates in the preparation and review of medical letters and other medical information materials.

Regulatory Support Activities:

• Participate in the development and review of label changes and labelling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
• Provide medical expertise to regulatory scientists.
• 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.

Scientific /Technical Expertise and continued development:

• 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
• Responsible for the scientific training of the clinical study team.

General responsibilities:

• Actively set and meet individual professional development goals and contribute to the development of others.
• Support the management team, in the preparation and administration of the budget.
• Actively participate in recruitment, diversity, and retention efforts.
• Collaborate proactively and productively with all alliance, business, and vendor partners.
• Participate in active coaching by providing timely and constructive feedback to co-workers, and others on the medical team, in the spirit of development, increased team effectiveness, and cohesiveness.
• Ensures that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self.
• Model leadership behaviours.

Basic Qualifications:

• An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MS with advanced clinical speciality (Clinical Nurse Specialist/Nurse Practitioner) and one of following

o 3-5 years of clinical experience or

o 3-5 years of pharmaceutical experience (2 of which are in clinical development)