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

Company: Moderna Theraputics
Location: Cambridge
Posted on: June 7, 2021

Job Description:

The Role:

Moderna Inc. is seeking a highly capable 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.

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 skills

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

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, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna's 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 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

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Keywords: Moderna Theraputics, Cambridge , (Contract) Sr./Manager, Clinical Contracts, Clinical Development, Other , Cambridge, Massachusetts

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