Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission ofRecovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
Patients First | Innovation | Winning Culture | Heart Recovery
Abiomed is seeking a driven and experienced Director, Clinical Affairs to work closely with the Medical Director, Clinical Research. The Clinical Research Scientist will provide support to multiple project teams at Abiomed. They will have the opportunity to make and impact through strategic and scientific input, as well as scientific support of programs. They will ensure successful design and implementation of science-driven clinical evidence generation strategies. Responsible for planning, implementing and executing job duties asassigned for clinical studies. Major areas of responsibility include contributing to clinical trial design and execution of company-sponsored clinical trials at all phases, clinical trial data analysis, internal and external communication of project plans and progress, safety monitoring and mitigation.
Principal Duties And Responsibilities
- Contribute to the design of clinical trials and the writing/review of protocol concepts, full study protocols, and other critical study documents
- Organize expert panels, steering committee and national PI calls, and meetings to provide input into the clinical plan, study design and data findings
- Anticipate risks and manage/mitigate them along with the Director of Clinical Research and Medical Affairs, Program Manager, and other team members, as appropriate.
- Oversee the conduct of clinical trials, making sure all clinical activities are carried out under GCP compliance.
- Assist CPM with managing other vendor activities
- Deliver high level presentations on company technology, investigational agents and/or clinical study issues to investigators and clinical site staff.
- Provide guidance and/or training to internal/external personnel/parties involved in clinical studies.
- Review clinical study and scientific data and perform analyses to enhance the understanding of clinical programs.
- Monitor analyses of emerging safety/tolerability findings.
- Facilitate, assist and/or participate in the preparation of clinical study manuscripts with investigators, internal personnel, and medical writers.
- Maintain expertise in the relevant therapeutic area; review scientific journals, attend key scientific and technical meetings, and partner with company medical, research, and translational teams
- PhD, PharmD, or MD highly desired
- Minimum of 7 years of clinical affairs experience in the biotechnology industry
- Experience in Cardiovascular disease and Class III devices a plus
- Exemplary critical thinking, problem solving and decision-making skills
- Proficient knowledge of GCP/ICH, study design, statistics, and clinical operations
- Excellent verbal and written communication skills and interpersonal skills. Ability to effectively communicate and collaborate across job functions and levels
- Proven scientific writing skills, including ability to evaluate, interpret, and present complex data
- Creativity and/or ability to put innovative approaches into practice in clinical development
- Strong sense of teamwork, ability to influence others and build collaborative relationships
- Resilient and tenacious with willingness to challenge ideas and assumptions
- Flexibility and willingness to adapt to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism
- Self-motivated leader able to manage and motivate site research teams, establishing goals; monitoring results to achieve tactical goals
- Proficient with Microsoft Outlook, Word, and Excel; and understanding of database programs is extremely helpful.
- Proven ability to work in a multicultural, global environment
- Willingness to travel (up to 20%)
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.