Sr. Director, Commercial Legal - North America

Company: Moderna Therapeutics
Location: Cambridge
Posted on: April 6, 2021

Job Description:

Cambridge, Massachusetts G&A The Role:Reporting to the Vice President and Associate General Counsel, Commercial Legal and Public Policy, the Senior Director, Commercial Legal - North America will take responsibility for providing legal support for the commercialization of Moderna's COVID-19 vaccine and, over time, other assets transitioning to commercialization in the United States and Canada. This position provides a unique, rewarding, once-in-a-career opportunity to support commercialization at scale for a small biotechnology company in the context of a Global pandemic while building the Legal function to support long-term growth.Here's What You'll Do:

• Provide legal advice on the implications of FDA regulation, Anti-Kickback Statute, and False Claims Act for strategies and tactics related to commercialization
• Collaborate actively with various internal stakeholders in service on the promotional review committee, grant review committee and medical review committee
• Support Medical Affairs activities, including speaker programs, conventions, advisory boards, and Scientific Engagement generally
• Boldly support the digital delivery of scientific engagement and promotional content, including providing guidance on the California Consumer Privacy Act and other privacy laws and regulations
• Provide legal advice on patient assistance programs, patient reimbursement programs, and market research
• Support the Sales organization, including sales training
• Collaborate with Compliance to mitigate enterprise risk generally, including supporting the drafting and implementation of SOPs and policies
• Support ex-North America commercial activities as needed
• Serve as business partner while also providing clear legal advice that communicates the magnitude of legal risks and identifies decision rights
• Be curious about Moderna's mRNA platform and relentlessly support its commercialization for its COVID-19 vaccine and in other modalitiesHere's What You'll Bring to the Table:
  • Minimum of a JD.
  • 6+ years of experience on commercial side of pharmaceutical or biotech industry required; expectation is that candidate held roles of increasing responsibility with demonstrated experience advising on FDA promotional regulation, Anti-Kickback Statute, and False Claims Act for strategies and tactics related to commercialization 5+ years of experience in public health, vaccines, epidemiology or related fields is a strong plus.
  • Extensive experience supporting contracting with payors and in the US channel space, including wholesalers and distributors, integrated delivery networks, and retailers
  • Substantial experience supporting a marketed pharmaceutical (preferably vaccines), including experience supporting promotional review committees
  • Understanding of the US vaccines eco-system, including CDC contracting, ACIP recommendations, and vaccines commercial models
  • Ability to collaborate and provide support across a broad range of key areas, including marketing, market access, Scientific Engagement, supply chain/planning, communications, and Business Development.
  • Intense sense of urgency, curiosity, and ambition to excel and build something from the ground up, navigating all the requisite ambiguity and complexity that comes with writing the rulebook while executing in real time.
  • Excellent communication, presentation, collaboration and influencing skills across internal and external stakeholders.Here's What We'll Bring to the Table:
    • On-site subsidized cafeteria or catered lunches
    • Company-provided iPhone
    • Free parking, monthly subway pass or a subsidized commuter rail pass
    • Free annual corporate membership to Bluebikes
    • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
    • Flexible Spending Accounts for medical expenses and dependent care expenses
    • 16 weeks of 100% paid parental leave for all new parents
    • 16 weeks 100% paid family caregiver leave
    • 20 weeks 100% paid medical leave
    • Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
    • Adoption assistance and discounts to local childcare centers, as well as access to care.com
    • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
    • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
    • Voluntary legal assistance plan
    • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays) About Moderna: In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com .Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. #LI-LW1- Posted 30+ Days Ago Full time R3621 About Us Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies M oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

Keywords: Moderna Therapeutics, Cambridge , Sr. Director, Commercial Legal - North America, Legal , Cambridge, Massachusetts