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Sr. Manager, Clinical Contracts, Clinical Development at Moderna Therapeutics

Posted in Other 30+ days ago.

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Type: Full Time
Location: Cambridge, Massachusetts





Job Description:

THE ROLE:

Moderna Inc. is seeking a highly capable clinical contracts manager with strong contract development and negotiating skills to support execution of drug development programs. This key role will report to the Sr. Director of Business Operations and will be responsible for managing the processing of clinical contracts from the identification of need through drafting, review, negotiation, approval, execution, analysis, tracking, and reporting. This is an exciting and interdisciplinary role for a qualified, organized, and motivated individual.

HERE S WHAT YOU LL DO:

* Vendor/Consultant Contract Preparation and Negotiations: Manage drafting of contract documents for outsourced services, either by outside party or Moderna legal department. Review contract documents, ensuring the use of appropriate templates and adherence to master service agreement terms as applicable. Negotiate contract terms as needed. In collaboration with legal department and clinical outsourcing director, ensure that final contracts cover the necessary scope and are consistent with company requirements, applicable regulations, and good business practices. Manage the contract execution process according to Moderna requirements. Advise internal customers on appropriate type of agreement addressing their needs.

* Site Contract and Budget Preparation and Negotiations: Support the development and maintenance of clinical trial site reference budgets through the management and use of licensed or internal benchmarking tools. Liaise with internal clinical operations leads, legal, and CRO partners to develop site budget negotiation parameters and approval of site contract templates.

* Contract Maintenance: Ensure contracts executed by Moderna are requested and tracked within legal database. Maintain contract archive. Prepare reports as needed. Review metrics related to the contract process and take appropriate action to improve efficiency and timeliness of contract processing.

* Process and Template Development: Support development and updating of Moderna s processes and tools, including contract templates. Participate in corporate initiatives.

* During all stages of activities, interact with internal customers, outsourcing, legal and finance departments, and other functions as appropriate, managing high volume of contract requests to meet project timelines.

HERE S WHAT YOU LL BRING TO THE TABLE:

The candidate will be expected to thrive in a fast-paced, dynamic, and nimble environment of an emerging company that depends on strong links and collaboration with external stakeholders (CRO partners, research organizations, alliance partners, etc.).

* Degree in scientific, economic, or legal discipline, or equivalent, with 5+ years pharma/biotech/CRO industry-related experience or equivalent, to include at least 3 years of experience in clinical contract negotiation and finalization.

* Sound understanding of drug development processes both in small molecules and biologics and experience with clinical development / clinical research organizations.

* Demonstrated understanding of project management principles as well as sound knowledge of contract terms and conditions, benchmarking and market analysis skills; must have high degree of energy, accuracy and attention to detail.

* Outstanding communication skills, including excellent verbal and written communication skills, an innovative approach to problem-solving, and an integrated view of business and scientific issues.

* Must possess good organizational and interpersonal skills as well as great attention to detail.

* Ability to thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient is essential.

* Ability to work independently and successfully in a matrix environment, and to prioritize and manage multiple tasks simultaneously.

* Ability to work in a multicultural team environment and interact with a wide variety of customers. Must be able to relate effectively to people at all levels of the organization.

* Ability to integrate cross-functional issues and balance competing priorities effectively.

* High degree of communication, facilitation and problem-solving attitude with complex negotiation and conflict resolution skills

* Skilled at developing and maintaining professional interpersonal relationships with colleagues internally and externally in order to complete the given tasks.

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 and cardiovascular 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 four 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.

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