Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

The Senior Corporate Counsel is responsible for leading a team of two Corporate Counsels in providing broad legal support and guidance to several groups within Abiomed, including to the Clinical Programs team in accelerating the start-up, maintenance and closeout activities of Abiomed’s clinical and pre-clinical research, and to the Regulatory team in ensuring regulatory compliance in all parts of Abiomed’s business. This position is based at Abiomed’s headquarters in Danvers, MA, and will report to the Vice President, Board Attorney. As a valued partner to the business, the Senior Corporate Counsel will be the direct point of contact for senior business leaders within the company and provide legal advice on a wide array of matters.

KEY RESPONSIBILITIES:

• Provide day to day support and counsel to the Clinical Programs team in the preparation and execution of all global research & development activities and draft, review, and negotiate all documents related to research, including but not limited to Clinical Trial Agreements, Investigator-Sponsored Study Agreements, Informed Consent Forms, Steering Committee Agreements, Data Use Agreements, Clinical Research Organization Service Agreements, etc.
• Work closely with Clinical Programs and Quality teams to develop, maintain and implement research-related policies and trainings
• Provide day to day support and counsel to the Regulatory team in the management of applications, responses, and audits by regulatory authorities
• Educate and advise senior management on laws, rules and regulations governing medical devices in the US

REQUIREMENTS:

• Juris Doctor or comparable legal degree and authorization to practice law in Massachusetts
• Minimum of 10+ years corporate in-house or law firm experience in Life Sciences, preferably with a medical device company or a CRO
• Proven specialization and expertise in legal support of global clinical trials and general contracting
• Familiarity with US and EU laws and regulations governing medical devices and clinical trials
• Experience leading and managing a team
• Self-starter and a team player with creative problem-solving ability
• Demonstrated experience working independently to identify, analyze, and solve problems

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. Abiomed maintains a drug-free workplace.