Cambridge, MA30+ days ago
Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other DMDs/DSDs/CSs, has the capacity to train them on the medical/scientific strategy by indication Key responsibilities include: Leading the clinical development plan strategies: Responsible for the clinical development plans and clinical sections of integrated development plans (IDP) Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects Prepares Internal Governance documents and contributes to the medical aspects the TPP, TVP and other GPT documents related to one or several indications of the IDP in support of the GPH Collaborate with other DMDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams Raise study or project-level issues to the project head and propose related corrective action plans Collaborates with external partners, regulators, scientific experts and internal stakeholders Provide operational expertise to project clinical sub team, as needed Evaluates relevant medical literature and status from competitive products Lead, Support and oversee the execution of clinical development and studies activities Collaborate and communicate appropriately with all function stakeholders (e.g. Main Responsibilities:The role of the Senior CRD is to: Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs Collaborate with other medical and clinical scientific experts CRDs or DSDs in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g.