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(Contract) Sr. Manager, Clinical Contracts, Clinical Development

Company: Moderna Therapeutics
Location: Somerville
Posted on: January 14, 2021

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 Director of Clinical Outsourcing 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. The anticipated time frame for this assignment is six months.Here---s What You---ll Do:Vendor/Consultant Contract Preparation and Negotiations: Manage bidding process and drafting of contract documents for outsourced services, either by outside party or Moderna legal department. Prepare requests for proposals for outsourced services. Coordinate cross- functional review/assessment of proposals as part of overall vendor selection process. Review contract documents, ensuring the use of appropriate templates and adherence to master service agreement terms as applicable. Negotiate budget and 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 request for proposal and contract templates. Participate in corporate initiatives.During all stages of activities, interact with internal customers, procurement, 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 skillsSkilled at developing and maintaining professional interpersonal relationships with colleagues internally and externally in order to complete the given tasks.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 & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and BARDA. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit .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-DNI Full time

Keywords: Moderna Therapeutics, Somerville , (Contract) Sr. Manager, Clinical Contracts, Clinical Development, Executive , Somerville, Massachusetts

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