Description de l'invitation he Clinical Scientist assists the Head Medical Strategy & Development in all areas of project /study planning and works in cross-functional Clinical Team(s) to move new potential therapies from preclinical to early clinical development.As an addition to our skilled project teams we are looking for a creative and collaborative colleague to support a dynamic and growing clinical development organization. In this role you will work together with experienced colleagues across Research and Development in the screening and functional characterization of our therapeutic DARPin molecules.Location: USA – (East Coast) or SwitzerlandPlease note, that this position requires travelling This challenging and diverse position will include the following tasks and responsibilities:Provide technical and operational leadership and work in cross-functional teams to move new assets from preclinical to early clinical development;Participate in the design/ execution of the clinical development strategy and plan and ensure GCP and SOPs are followed;Responsible for clinical oversight of one or more clinical studies;Develops clinical and scientific aspects of study protocols, informed consent forms and other relevant clinical documents (SAPs, IDMC, SMC, SSC, DERC Charters), including clinical study reports (CSR);Responsible for high standards of study conduct and maintenance of records;Possibility to present at Investigator meetings, Steering Committee Meetings, safety data review committees and training meetings;Act as a liaison between external partners (CRO, investigators and/or experts);Interface with project team members including: Clinical Operations, Data Management, Statistics, Pharmacovigilance, Medical Writing and Project Management;Work closely with Clinical Operations to ensure adequate executions of clinical aspects of the study;Lead or assist with Competent Authority and Ethics Committee/IRB submissions (e.g. INDs, CTAs);Lead and participate in ongoing monitoring of clinical activities and study conduct, coordination of data collection, clinical data review, analysis and interpretation;Identify trends/problems/ issues that could affect the results or completion of the study;Preparation and presentation of results for informed decision-making;Conducts literature reviews and prepare summaries to support clinical development programs;Provide training and science input to operation colleagues and study site staff:
Description du candidat For this position, we are looking for a highly motivated individual bringing along:Undergraduate degree required, advanced clinical/science degree preferred (e.g. MD, PharmD, PhD) or equivalent relevant experience;Must have experience in the pharmaceutical industry (5+ years), and working on clinical trials as a Clinical Scientist (3+ years);Experience with Radiopharmaceutical Diagnostic is a Must;Experience with Therapeutic Studies (3+ years);Experience with clinical trials in Oncology is a plus;Working knowledge of Phase I – II drug development;Knowledge of clinical aspects of GCP / ICH, FDA, EMEA and other relevant guidelines and regulations;Experience in medical writing e.g. authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, safety reports, patient narrative, and applying organizational SOPs;Proven ability in problem solving and issue management that is solution focused;Experience in outsourced CRO models and in working with safety data review committees for dose finding is a plus;Strong team player with good communication skills to work in a team environment as leader and key contributor;Ability to acquire scientific knowledge and technical information;Highly motivated and energetic with a can-do attitude;Excellent written and oral English skills;Willingness to travel (national and international).
