This newly created role is an exciting opportunity to be an important part of a growing legal team. The Counsel, Clinical Development will be primarily responsible for the management of clinical contracting for various programs across all phases of clinical research and will serve as a key legal business partner for the Clinical Development and Regulatory teams and other relevant stakeholders. This role reports to the VP, Associate General Counsel, Clinical Development and Regulatory and is based in Cambridge, MA. Candidates in remote work locations are encouraged to apply.
Heres What Youll Do:
The successful candidate will have extensive front-line interaction with the Clinical Development team and our partner CROs and will divide time between contract negotiation and management and clinical and regulatory business partner advisory work
Negotiate, draft and manage high-volume of specialized agreements necessary for day-to-day clinical operations and startup and management of clinical trials. These agreements include clinical trial, confidentiality, informed consent, consulting, letters of indemnity, investigator-initiated study, and vendor services agreements
Serve as a day-to-day legal business partner for the Clinical Development team
Strategize with the Clinical Development team on all aspects of clinical site and vendor contracting, including template development and management, creation and review of fallback documents, and contract interpretation
Lead and contribute to the ongoing improvement and development of legal processes and procedures
Join a dedicated team of individuals with highly specialized and deep industry experience and will have a critical role in servicing the business
Heres What Youll Bring to the Table:
JD from an accredited law school; active membership in at least one state bar
A minimum of 5 years of experience negotiating clinical contracts is required
Prior experience with vaccine clinical trials and regulatory matters is strongly preferred
Excellent legal drafting ability is critical
Familiarity with US and international clinical trial contracting practices, as well as common intellectual property, regulatory, data privacy, liability, and insurance issues is expected
Well-versed in industry standards and key issues in specialized agreements, familiar with policies and practices of leading non-profit academic institutions and research hospitals
Sophisticated communication skills, and comfort and confidence to interact directly with clinical operations and CRO partners
The ability to prioritize and manage multiple tight deadlines in a frequently high-paced environment is necessary
Exceptional judgment and ability to quickly assess business challenges, make timely, pragmatic recommendations under pressure, and identify, prioritize, and resolve issues quickly and independently
Heres What Well 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)
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.
To apply for this job please visit www.goinhouse.com.