General Counsel

Company Description

Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries. 

At Sirtex, we’re transforming our industry through our leadership with interventional oncology and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. We offer stimulating careers and development, encourage innovation, and strive for excellence in everything we do. We will always foster a diverse and inclusive workplace, in which our global teams are united by an unwavering commitment to improve the quality and longevity of patients’ lives by providing innovative interventional oncology solutions. 

Here, you will be a vital contributor to our inspiring and bold mission. 

Job Description

SCOPE:

The General Counsel is a business-oriented attorney with experience developing, implementing, and managing legal and compliance strategies in pharma/Medical Device companies with a drive to ensure that departmental results match regional goals and objectives.

PRIMARY RESPONSIBILITIES:

Legal Responsibilities:

• Manage the in-house legal/compliance team to support the growing business
• Provide expertise in legal counsel matters such as but not limited to Marketing, Sales, Regulatory, Medical, Compliance, Clinical, and Human Resources.
• Manage the use of internal versus external legal counsel to minimize cost and risk
• Prepare, review and negotiate complex commercial agreements, 3rd party vendor agreements, service agreements, consulting agreements, corporate agreements, confidentiality agreements and IIT/Grant agreements.
• Support commercial organization in negotiating, development and maintaining contractual relationships. Identifying and communicating issues and risks for agreements.
• Support the commercial operations by providing substantive advice to the Sales, Marketing, Medical Affairs and Corporate teams concerning a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, AdvaMed, Sunshine Act, Foreign Corrupt Practices Act and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, government reimbursement and interactions with healthcare professionals.
• Provide legal advice and assistance for the development of policies and training and conducting training of newly hired employees
• Manage patent and trademark portfolio and other intellectual property issues that may arise.
• Resolve routine and complex legal matters and manage them appropriately
• Communicate legal issues and risks to stakeholders regarding Sirtex business
• Keep up to date on change in laws that impact medical device, human resources and other areas as needed
• Serve as a trusted resource to colleagues regarding legal, compliance, and other areas of subject matter expertise

Qualifications

• JD Degree from an ABA accredited law school
• Admission to the Bar in Massachusetts or willing to be admitted to the Massachusetts Bar
• 9+ years of experience as an attorney/counsel, with at least 5 years supporting clients within the pharmaceutical, medical device or biotech industries.
• Demonstrated experience drafting and negotiating contracts for the Life Sciences industries.
• Exceptional written, verbal, and presentation communication skills, including strong contract drafting skills
• Ability to translate complex legal principles to management and other line function personnel
• Ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees
• Familiarity with FDA drug law, False Claims Act, Anti-Kickback Statute, OIG guidance, the AdvaMed Code, the Sunshine Act, Foreign Corrupt Practices Act, competition law and US medical devices compliance program requirements
• Ability to work collaboratively and effectively, as a team leader and a team member, with all internal and external partners and stakeholders

The target base salary range for this position will range from $366,000 to $403,000 annually. Individual compensation for this job requisition will be based on non-discriminatory factors, including your geographic location, skills, experience, education and other factors as they relate to the position requirements. Actual compensation may vary depending on the confirmed job-related skills and e