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Medical Director, Clinical Trials and Outcome Research

Date:  Jul 7, 2021
Location: 

Danvers, MA, US

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering 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 the leader in the field of minimally invasive cardiac and vascular mechanical support and our mission is to Recover Hearts and Save Lives. Abiomed’s Impella & Breethe family of devices support the sickest patients in the hospital, and we are committed to continues research through the entire translational spectrum, from basic research to clinical studies.

 

We are looking for an inspiring leader to serve as a Medical Director for Abiomed’s strategic sponsored studies.

 

The Medical Director will report to the Sr. Director of Clinical Science, Safety, Operations and Translational Research (CORE) and will be responsible for leading and supporting Abiomed’s sponsored studies and for the development and execution of the company’s medical and clinical affairs strategy related to evidence generation and regulatory roadmap.

 

PRINCIPAL DUTIES & RESPONSIBILITIES:

  • Lead Abiomed’s PROTECT IV study, serving as the company’s liaison with the PI and Co-PI, the Steering Committee (SC) and the study sub-committees. Together with the assigned Clinical Program Manager (CPM), the Medical Director of the study will oversee all the study related activities including (but not limited to) protocol development, CRF and EDC development, site selection, site initiation and training. The Medical Director will serve as the primary Abiomed liaison with all site PIs.
  • Lead the cVAD study – Abiomed platform for its Post Approval Studies (PAS) - serving as the company’s liaison with the Steering Committee (SC) and the study sub-committees. Together with the assigned Clinical Program Manager (CPM), the Medical Director of the study will oversee all the study related activities, including (but not limited to) generating the annual reports to FDA and leading the team to the close-out of the various PAS over the calendar year 2021.
  • Lead the development Abiomed’s Outcome Research & Data Office (ORAD), which will serve as the company’s new platform for Real World Evidence generation. This program will include partnering with a leading Academic Research Organization, to create a yearly cadence of publications on safety, best practices, and various populations treated using the Impella and Breethe family of devices, as well as build capabilities for pragmatic nested studies.
  • Develop strategies that incorporate use of non-traditional data sources such as registries and real-world data as part of the ORAD
  • Support Abiomed’s Medical Office overall efforts with clinical investigational sites to ensure proper oversight / monitoring of Abiomed sponsored clinical trials
  • The Medical Director will play a key role in defining a strategic roadmap for Abiomed’s future Randomized Controlled Studies and RWE generation, across the current and potential future indications for the Impella and Breethe family of devices
  • Support Marketing and Regulatory Affairs in defining new patient populations that can benefit from Impella and Breethe family of devices and play a key role in defining Abiomed’s regulatory strategy and in discussions with FDA.
  • Establish and maintain a professional and credible image with key physicians, consultants, vendors and lead the development of posters and oral presentations for scientific meetings
  • Maintain knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to ABIOMED products
  • Initially the Medical Director will be an individual contributor, with the above key horizontal leadership positions. As Abiomed’s portfolio of RCTs grows, there may be future opportunities to expand this role and build a team around these functions.

 

QUALIFICATIONS:    

  • Medical Doctor (MD), training in cardiology is a key advantage
  • Experience as a practicing clinician is an advantage
  • 3+ years’ experience in supporting and managing large scale studies
  • Demonstrated success in trial execution with diverse research teams
  • Demonstrate deep knowledge of all the operational elements involved in running various types of clinical studies
  • Proficient in Good Clinical Practice
  • Excellent analytical skills, demonstrated ability to understand statistical methods, hypothesis testing, complex analyses of RCTs, sub-analyses and RWE. formal training in epidemiology and/or statistics is an advantage
  • Industry experience in a medical device organization (medical affairs, clinical research, or pharmacovigilance) is a major advantage
  • Experience working with senior executives
  • Strong interpersonal, leadership, motivational, and team-building skills, and the ability to work in a multicultural, global environment
  • Ability to make critical strategic business decisions and manage competing stakeholder expectations
  • Ability to travel frequently (average 50%), both domestically and internationally (EU and Japan primarily)

 

 

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.


Nearest Major Market: Boston