Sr. Director, Commercial Legal North America
Company: Moderna Therapeutics
Location: cambridge
Posted on: May 3, 2021
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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 Modernas 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. Heres What Youll 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 Modernas mRNA platform and relentlessly
support its commercialization for its COVID-19 vaccine and in other
modalities Heres What Youll 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. Heres What Well Bring to the Table: 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, Modernas capabilities have come
together to allow the authorized use of one of the earliest and
most-effective vaccines against the COVID-19 pandemic. Modernas 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 persons 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. - Posted 30+ Days Ago Full time R3621 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 bodys 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.
About Us
Keywords: Moderna Therapeutics, Cambridge , Sr. Director, Commercial Legal North America, Other , cambridge, Massachusetts
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