_This contract is for up to a 12-month period. This period may be extended or reduced based on business needs and candidate performance._ **Purpose of Position** Function as Clinical Scientist for program, and/or as delegate of Therapeutic area Lead/Medical Director for clinical development programs within Kedrion’s global organization. Work closely with Medical director to ensure patient safety, and that the global clinical trial programs and studies are in conducted accordance with company policies and procedures, Good Clinical Practice guidelines, and applicable regulations. Work alongside Therapeutic Area Lead, driving the design and data interpretation process, as well as establishing clear design objectives for clinical programs. Partner with other Departments such as Regulatory Affairs, Research and Development, and Operational Excellence to ensure appropriate scientific input is provided to support the company’s objectives. **Main Responsibilities and Accountabilites** + Provide expertise to the design, execution, and data interpretation for clinical trials. + Support activities related to drug development, including but not limited to: + Fulfil and comply with all clinical development duties, ensuring that clinical trials are performed to acceptable medical, scientific and ethical standards and meet the requirements as per protocol, company SOPs/policies, ICH GCP guidelines and local regulations. + Partner with Therapeutic Area Lead/Medical Director to ensure the medical wellbeing and safety of study participants through the safe performance and execution of the studies. + Leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal stakeholders + Develops clinical trial protocols, statistical analysis plans, clinical study reports, and other documents related to clinical trial design, conduct, and completion. + Authors/reviews various regulatory reports and correspondences: meeting requests and responses, annual reports, safety updates, IND submission documents + Contributes to PI oversight and quality of studies. Proactively participates and engages in driving delivery of study targets, thereby contributing to the commercial success of the studies which includes recruitment, enrolment and retention of study participants. + Review and coding of clinical trial data. + Work closely with company medical monitor and medical monitor at selected contract research organizations (CRO) to ensure appropriate documentation and reporting of safety events. + Author and/or review sections of regulatory submissions based on clinical trial data. + Work closely with colleagues in other functions including Regulatory Affairs, Pharmacovigilance, Medical Affairs, Labelling, Document Submissions, Commercial, Compliance, and Legal, as this activity relates to clinical trial execution. + May provide input into pre-clinical studies to ensure alignment of pre-clinical and clinical work. Involve in all phases of clinical study conduct. + Maintain professional knowledge of Good Clinical Practice, relevant legislation and related issues and act as a source of technical advice with respect to GCP, EU, UK, US and other global regulations. Acquire and maintain a high level of knowledge of the assigned therapeutic area, product and related areas of assigned clinical trials, by reading relevant literature and courses/seminars. + May provide input or content to SOPs or policies related to new regulations. + Participate in Department or Clinical Research initiatives to maximize efficiencies and cost-savings within projects and teams. Ensure lessons learned activities are identified and maximized throughout clinical trial programs. + May serve as a peer coach learning how to mentor and provides guidance to junior members of department and cross-functional team members as appropriate **Relations** + Internal: Counterparts of Regulatory Affairs, Supply Chain, Sales & Marketing, Pharmacovigilance, Finance, Legal Office, Medical Affairs, Pharmacovigilance, Quality. + External: Personnel involved in clinical studies KOL, CRO, Competent Authorities, Ethics Committees. **Regulations** + Adheres to all company policies, procedures and business ethics codes. + Operates in accordance with the laws in force, and with the voluntary standards applicable to his/her operating field. + Act in compliance with GCP and the reference regulations for clinical trials and operate according to the SOPs. + Respects the rules of confidentiality and integrity. Education + Must have a bachelor’s degree, advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MPharm/MSc) is preferred. ≥ 10 years of pharmaceutical/CRO clinical research experience is preferred.