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Clinical Research Director

il y a 4 jours

Massy

Clinical Research Director (CRD) About Corteria Pharmaceuticals Corteria Pharmaceuticals is a privately held company that develops first-in-class drugs in subpopulations of heart failure, including worsening heart failure, right heart failure and acute heart failure with hyponatremia. Our targets are selected based on human validation, and our development focuses on important unmet medical needs. To support the clinical development of our projects, we are looking for a Clinical Research Director (CRD) to manage the clinical activities of the company's products. Position Summary: The CRD is a physician with an established track record designing and monitoring the implementation of clinical trials. Must have strong clinical expertise in the field of cardiometabolic diseases and must be performance oriented with ability to work along agreed timelines and a focus on strategy and execution. Must have solid analytical skills and in-depth knowledge of good clinical practices, data handling, and ethical standards to ensure the safety and privacy of the patients. S/He must have the leadership skills required to oversee the CRO team and must also have strong communication skills to interact with the global clinical sites and external stakeholders. This individual must be able to work in a highly dynamic environment and perform at a high level of autonomy on multiple tasks. Major Duties and Responsibilities: Leadership: • Lead the cross-functional CRO team to successfully implement the clinical trials., • Provide appropriate medical input as subject matter expert to support all activities related to clinical studies such as medical training, feasibility, medical data review, for the CRO study team and other stakeholders., • Provide direction and guidance to the team and Implement strategies to identify and resolve clinical program/trial issues in close collaboration with the CRO, • Establish strong relations with clinical trial sites and external stakeholders to ensure proactive management of risks. Execution: • Draft the study protocols in close cooperation with ad-hoc consultants/contractors, such as biostatisticians and medical writers., • Liaise with CROs responsible for the selection and monitoring of clinical sites, data management, and safety reporting to provide medical oversight of clinical studies including medical/safety monitoring, protocol compliance and medical data review, • Support the drafting of key clinical documents such as: meeting requests and briefing packages for Regulatory Authorities, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), etc., • Write/review answers to clinical questions from Health Authorities and IRB/Ethics Committees and Investigators., • Provide clinical input to all study-related documents, such as informed consent forms, Case Report Forms, Risk Management Plan, Monitoring Plan, Safety Management Plan, etc., • Support the drafting/Review the Charters of Steering Committees, Endpoint Adjudication Committees, Data Monitoring Committees, and any other oversight or safety committees, as appropriate., • Assist with the development of presentations at site initiation visits and video-teleconferences with Investigators., • Review Key Results Memos, Clinical Study Reports as well as scientific publications and communications on the project., • Evaluates relevant medical literature from competitive products. Communication: • Good networking ability in cross-cultural environment, • Strong interpersonal, communication skills, • Excellent problem-solving, conflict-resolution and decision-making skills Requirements/ Qualifications: Education: • MD degree is required. Board certification/specialization in cardiology is preferred. Experience: • Minimum of five (5) years of drug development experience in a pharmaceutical company is required., • Experience in cardiovascular/metabolism clinical research is preferred. Language: o Proficient written and oral communication skills in English is key for this position Setting and reporting structure: Work setting: • Hybrid with 2 or 3 days/week at the Massy office Supervision: • Reports to the Chief Medical Officer

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