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Clinical Project Manager/Associate Director, Clinical Operations

REGENXBIO Inc


Location:
Rockville, Maryland
Date:
06/08/2017
2017-06-082017-07-08
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
REGENXBIO Inc
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Job Details

ABOUT THE ORGANIZATION      

REGENXBIO is a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy. Our NAV Technology Platform, a proprietary AAV gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. Our mission is to transform the lives of patients suffering from severe diseases with significant unmet medical needs by developing and commercializing in vivo gene therapy products based on our NAV Technology Platform. We seek to accomplish this mission through a combination of our internal development efforts and the efforts of our third-party licensees (NAV Technology Licensees).

Our most advanced internally developed candidates include programs for the treatment of two severe and rare genetic diseases, homozygous familial hypercholesterolemia (HoFH) and Mucopolysaccharidosis Type I (MPS I). In addition, we have a preclinical program for wet age-related macular degeneration (wet AMD) as well as two additional research programs. REGENXBIO plans to build internal gene therapy franchises in the metabolic, neurodegenerative and retinal therapeutic areas, and develop multiple product candidates in these and other areas.  

REQ NUMBER    CLI-17-00005     

DESCRIPTION    

The Associate Director/Clinical Project Manager will be responsible for the planning and implementation of one or more clinical trials within a therapeutic area. The incumbent will be responsible for the execution of the clinical trial operational plans to meet the overall development strategy and will ensure that clinical trials are conducted in a timely fashion and compliant with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and regulatory guidelines, company goals, and budgets. The Associate Director/Clinical Project Manager will manage the day to day execution of the trial and ensure the execution is meeting the operational plans and company goals. The AD/CPM may also have direct reports. The incumbent will also be able and willing to perform all duties or functions of subordinates.

 

Responsibilities:

  1. Develops and maintains the clinical trial deliverables including timelines, budgets, and resource requirements within a therapeutic area
  2. Attends and supports the clinical sub team
  3. Provides matrix management of cross functional representatives to manage clinical execution deliverables
  4. Defines and manages accountabilities for CTT team members
  5. Reviews and refines clinical operations plans for each study
  6. Develops and constructs content for risk mitigation plans related to the study to ensure clinical trials are on time and within budget
  7. Implements clinical trial ensuring that clinical trials are conducted in a timely fashion and compliant with SOPs, GCP, and regulatory guidelines, company goals, and budgets
  8. Partners with clinical development and cross functions to draft the Clinical Protocols, Investigator’s Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs), and manages timelines for completion of these documents
  9. May lead selection process for outsourced activities
  10. Leads the selection of specialty vendors (if needed) including development of scope of services agreements, budgets, and plans and timelines
  11. Manages CRO/vendor agreements, ensuring that change orders and budgets meet clinical operations specifications
  12. Reviews invoices for accuracy compared to operational plans, budgets, and work known to be performed by CRO/vendors
  13. Lead ongoing review of data to ensure quality and consistency through study execution
  14. Manages CRO/vendors to achieve goals and ensures that performance expectations are met
  15. Responsible for working with the CRO to plan everything from early engagement for protocol feedback to database lock
  16. Participates in patient identification activities and the development of patient recruitment plans and back-up plans
  17. Identifies, recruits, and approves clinical investigators in collaboration with Medical Monitor and Clinical Operations leadership
  18. Ensures that all supportive study-related documents are completed (e.g. Monitoring Plan, IXRS, Study Reference Manual, Laboratory Manual, Pharmacy Manual, CRF Completion Guideline, etc.)
  19. Ensures that all monitoring activities and processes are complete, including training of internal and external resources, and are compliant with SOPs and GCP/ICH/regulatory guidelines
  20. Ensures quality of data generated from clinical sites and assists in resolving patient eligibility and protocol deviation issues
  21. Manages internal supporting staff to ensure that all activities are moving according to trial timeline
  22. Recommends and implements innovative process ideas that impact clinical trials and/or clinical program management
  23. Participates in the development of clinical operations quality systems, including SOPs, document management, clinical operations personnel training, and quality control processes
  24. Contributes to wider organizational goals and/or activities as assigned
  25. Manages clinical operations personnel, including hiring, training, coaching, and performance reviews

 POSITION REQUIREMENTS        

  1. Possess a combination of educational and work experience demonstrating competencies to perform the duties and responsibilities of the position
  2. Bachelor’s degree in biological science preferred
  3. Minimum of 8 years’ progressive experience in clinical operations with thorough understanding of cross functional clinical processes including clinical supply, data management, biostatistics, and medical writing
  4. At least 5 years in clinical project management is required
  5. Experience in managing cross functional team members during trial execution a must
  6. Basic understanding of country level regulations, ICH and GCP guidelines required
  7. Strong knowledge in GCP and ICH and of the application process to conduct clinical trials
  8. Ability to function in a fast pace, dynamic environment
  9. Ability to deal with ambiguity
  10. Ability to clearly develop action plans to ensure delivery on company strategy and goals as well as clinical development plans
  11. Strong interpersonal and negotiation skills
  12. Proven complex problem solving and decision making skills
  13. Must be a demonstrated self-starter and team player with strong interpersonal skills
  14. Excellent written and verbal skills
  15. Must display strong analytical and problem solving skills
  16. Must be able to travel

 

LOCATION           Maryland - 9712