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Clinical Contracting Manager, Clinical Operations

Company Profile

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Genentech, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

Job Summary

The Clinical Contracting Manager will support the outsourcing and contracting needs of Inovio’s clinical programs. This Outsourcing Manager will be a member of the clinical project team and will be key team member during the generation, negotiation and execution of clinical trial vendor contracts. The individual will work closely with our legal department ensure that the contract terms, statement of work (SOW) and budget meet the needs of both the clinical trial and all legal requirements. This individual will also be responsible for managing and facilitating any change orders to the SOW.

Essential job functions and duties

  • Lead vendor evaluation and selection process including generation of Request for Information (RFI) if new vendors need to be identified.
  • Ensure confidentiality agreements are executed as required.
  • Generate the Request for Proposal (RFP), performing analysis of the responses, and leading the clinical study team discussion of vendor selection.
  • Work closely with legal and clinical operations and other relevant functional groups for review and escalation of contract and budget issues.
  • Assist the legal team in contract negotiation and execution for vendors supporting a clinical trial.
  • Act as the primary contact with vendors for negotiation of the scope of work, study assumptions and budgets.
  • Support cross-functional relationships with clinical operations, legal and finance
  • Maintain study-level financial tracking of vendor contracts with ongoing reconciliation of study budgets versus vendor invoices.
  • Participate in study team and report status of study-specific contracts.
  • Responsible for the generating requests for Master Service Agreements (MSA), work orders, purchase orders and Consulting Agreements as requested
  • Perform follow-up activities for accounts payable issues as requested by clinical teams or other functional groups.
  • Follow up or escalate vendor requests for payment information.
  • Perform other duties as required.

Minimum Requirements

  • 4 year degree in scientific or business discipline, MBA preferred or equivalent work experience
  • 3-5 years of procurement /category management expertise in a clinical research setting
  • Site contracting expertise is preferred
  • Knowledge of GCP and regulatory requirements regarding clinical trial management
  • Strong verbal and written communication skills as well as interpersonal and organizational skills
  • Excellent negotiation skills
  • Ability to work in a team environment and collaborate with internal functional groups.
  • Analytical and strategic thinking skills
  • Attention to detail, ability to prioritize and handle multiple projects.
  • Self-starter, able to communicate well within a team environment. 
  • Proactive in managing and completing tasks in a timely fashion.
  • Proficiency in MS Office applications, especially Excel

Disclaimer

Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.  

 

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