Senior Director, Commercial Compliance

Company: Mersana Therapeutics
Location: Cambridge
Posted on: May 23, 2023

Job Description:

What's in it for you?In this role, you would have the opportunity to be a member of a dynamic, growing Legal Team focused on providing high quality legal and compliance services to the organization. You would be a pivotal contributor to the growth and evolution of the Company by helping develop, educate, train and advise on commercial and compliance matters. You would provide legal, compliance and strategic guidance to various cross-functional teams supporting the Company's late-stage product development and commercial preparedness matters. You would report to the Company's Vice President, Deputy General Counsel, have a dotted line reporting relationship with the Chief Legal Officer, and work closely with them and other members of the Legal Team across a range of matters. To be successful, you would have previous and deep experience as a brand attorney, providing commercial legal counsel to business clients, guiding the development of compliance programs and policies, conducting relevant training on matters relating to commercial and compliance operations and engaging in medical and promotional review. You would be comfortable working in a fast-paced environment, with a demonstrated ability to parallel process multiple projects with competing timelines. This is an opportunity to be a part of a growing biotech focused on cancer drug development with a thriving mission-focused culture. How do you know if you're the right fit?Your background and experience will allow you to:

• Provide business-oriented and compliance-minded commercial legal advice to cross-functional product-focused teams and stakeholders involved in the Company's commercial preparedness activities
• Review and advise on promotional and medical materials; participate in relevant committees
• Partner with the Chief Legal Officer and Deputy General Counsel on the development, customization and implementation of a comprehensive healthcare compliance program to prepare the organization for commercial launch of its first pharmaceutical product, including the development of a range of policies, procedures training, and auditing and monitoring programs
• Participate on other commercial and medical affairs committees (e.g. Congress Planning, Investigator-Sponsored Trials Review Committee, Grant Committee) on an as-needed basis
• Demonstrate an ability to solicit and integrate business feedback from various stakeholders in the development of commercial and compliance programs, policies and guidelines
• Appreciate complex and nuanced commercial and compliance matters, with an ability to engage in strategic discussions with business teams to optimize the Company's position
• Demonstrate expertise in biotech and life science commercial and compliance matters, including without limitation FDA, EMA, relevant industry associations relating to anti-kickback, anti-bribery, fraud and abuse, transparency and other healthcare compliance matters
• Collaborate with, and provide value-added guidance to multiple stakeholders, including drafting and negotiation of contracts for commercial activities, relevant service agreements, consulting agreements, pricing agreements and government and payer contracts
• Serve as a well-respected, credible expert throughout the organization, with the ability to provide business-oriented, practical guidance across a wide array of substantive commercial and compliance areas
• Collaborate fluidly with all members of the Legal Team relating to a broad range of topics and special projectsThe other stuffThis role is best suited for a seasoned and strategic lawyer (JD) with at least 10 years of legal experience. In-house, industry experience is required. Additionally, the perfect person for this role will have:
  • Demonstrated experience and accomplishment in a broad range of commercial legal and compliance matters relevant to the biotech/life sciences industry
  • Proven ability to quickly assess fact-patterns and/or situations and provide guidance based on sound judgment and common sense
  • Experience advising business stakeholders on strategic matters
  • Excellent oral and written communication skills that enable effective interactions with internal client groups as well as with colleagues on the Legal team
  • Willingness to develop and provide mentorship to clients and peers within the Legal Team
  • Awareness of the landscape of relevant developments in laws applicable to the Company's current and planned business and be able to provide appropriate guidance to the Company
  • A proven ability to organize and execute on multiple complex tasks in parallel, ensuring that deliverables are completed in a timely manner
  • High attention to detail and accuracy as well as comfort working in a fast-paced environment.
  • The desire to become well-versed in the business environment of the Company
  • A commitment to be a collegial team player with a healthy sense of humorPosition is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation and paid holidays.Successful candidate must be authorized to work in the United States.Mersana Therapeutics, Inc. is an equal opportunity employer.

Keywords: Mersana Therapeutics, Cambridge , Senior Director, Commercial Compliance, Executive , Cambridge, Massachusetts