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Sr. Counsel, Clinical Development

Company: Moderna Therapeutics
Location: Cambridge
Posted on: September 14, 2020

Job Description:

Description

The Role:

This newly created role is an exciting opportunity to be an important part of a growing legal team. The Sr. Counsel 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.

Here s What You ll 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

Leads and contributes 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

Here s What You ll 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

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:

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science s list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com .

Our Mission:

Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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-NB1R2491

Job Information

Job ID: 54600029

Location:

Cambridge, United States

Position Title: Sr. Counsel, Clinical Development

Please refer to the company's website or job descriptions to learn more about them.

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Keywords: Moderna Therapeutics, Cambridge , Sr. Counsel, Clinical Development, Other , Cambridge, Massachusetts

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