Abbott Clinical Science Manager in Diegem, Belgium
We have an exciting opportunity for the right candidate to join our rapidly growing clinical team within the Abbott Structural Heart division. The Clinical Scientist manager will provide scientific expertise throughout the development and execution of clinical strategies (e.g. clinical trials, scientific publications) to support evidence generation for transcatheter or surgical aortic programs. He/she will design clinical trials from concept to execution by working collaboratively with biostatistics, medical affairs, regulatory affairs, global clinical operations, and other cross-functional team members. The individual will also take the lead in interacting with regulatory agencies, reimbursement agencies and clinical trial investigators to ensure successful execution of clinical strategies to meet corporate goals.
Core Job Responsibilities
This position will work closely within the clinical study team including the medical director, biostatistician, project management, data management, and other clinical study personnel. This position will have significant interaction with executive leadership, physicians and regulatory authorities. Furthermore, this position will be required to execute their job responsibilities within the corporate policies and standard operating procedures. This position will:
Design clinical trials and studies in collaboration with internal stake holders including clinical project management, clinical operations, clinical science, biostatistics data management, regulatory affairs, medical affairs as well as external stake holders including steering committees, and national principal investigators (if applicable).
Lead the generation of study-related documents and/or contribute content and oversight of such documents, including, but not limited to, clinical study protocols, case report forms, clinical study reports, and informed consent forms
Develop the scientific podium and publication strategy in close collaboration with cross-functional teams, and lead the execution of the publication strategy
Lead publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts
Support the Clinical Program Director in developing clinical evidence generation plans
Serve as an active member of study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol development. May include generation of pre-protocol documentation of scientific information
Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area
Review and critically analyze statistical analysis plans
Lead study level (and franchise level where applicable) publication planning
Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions
Contribute to the optimization of internal processes and workflows
Develop new ideas for both external and internal projects.
Attend, present at, and leads meetings with FDA.
May manage junior team members
Performs other related duties and responsibilities, on occasion, as assigned
To be considered for this role, you need to hold a PhD and have a minimum of 10 years relevant experience.
Previous experience in the medical sector is required and experience in heart valve would be an asset.
Fluency in English is essential (written and spoken) as well as previous experience dealing with various stakeholders.
Flexibility to travel up to 25% is also important for the role.
If you recognize yourself in this profile and you would like to know more, please apply online.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com