Aldeyra Therapeautics, Inc.

Position Summary:

The primary responsibility of the Clinical Program Manager/ Senior Clinical Program Manager (CPM/Sr. CPM) is to provide direct oversight of clinical operation activities at Aldeyra Therapeutics across one or more clinical programs.  The CPM/Sr. CPM may assume the role of Clinical Program/ Trial Lead where necessary.  The CPM/Sr. CPM will manage several external clinical consultants and service providers.

Essential Functions:

  • Contribute to the development of clinical project plans and implementation of those plans in accordance with corporate and regulatory objectives
  • Direct oversight of clinical operation activities (trial management, site monitoring, vendor management, Trial Master Files, and others) for one or more clinical programs
  • Development and approval of key study documents in conjunction with other functional area leads assigned to a project (e.g. protocols, project plans and timelines, statistical analysis plans, final study reports, etc.)
  • Identify, resolve, and escalate issues that jeopardize timely clinical study completion
  • Lead study site selection in collaboration with internal team and vendor(s)
  • Identify and select vendors based on clinical trial needs and constraints related to resourcing or budget
  • Actively manage vendors to ensure study activities are performed to expected quality and timeliness
  • Build and manage relationships with sites
  • Ensure audit readiness status for clinical trials
  • Develop clinical trial budgets, resources, and reforecasting projections
  • Communicate study updates to internal teams/senior management
  • Contribute to the development of Clinical Operations goals and objectives and help drive the initiatives that meet those goals and objectives
  • Contribute to the development of Clinical Operations SOPs and associated guidelines and templates
  • Monitor departmental compliance with required training and adherence to all corporate and departmental SOPs, GCP/ICH guidelines and QC/QA procedures

 

Qualifications:

Required:

  • Bachelor’s degree in a clinical, scientific, or related discipline
  • 8+ years demonstrated experience in a biotech/pharmaceutical/CRO company, clinical research site, or related healthcare company including 3+ years clinical operations/project management experience
  • Possess strong project management, organization, communication (oral and written), and analytical capabilities
  • Experience managing and/or coordinating vendors and contractors
  • Experience with a multi-phase clinical program or experience across multiple phases of clinical drug development
  • Develop and manage the Clinical Operations outsourcing strategy including RFP generation, negotiation, capabilities assessment, and selection. Obtain buy-in and promote its success. Oversee the day-to-day performance of CROs and other vendors
  • Participate in Clinical Operations budgeting and program management activities
  • Participate in the development and review of SOPs and Clinical Operations systems
  • Excellent interpersonal skills and able to work in a matrix environment both internally and externally; has the ability to foster relationships
  • Ability to travel 20%

Desired:

  • Advanced degree (MS, PharmD, PhD, or MD or equivalent professional)
  • Prior experience with immune-mediated diseases/rare disease/ophthalmology, orphan drugs, and managing global clinical trials
  • Demonstrates expertise in and understanding of cross-function clinical trials processes from study start-up through study closure (e.g., data management, safety, biostatistics, medical writing) with proficiency in clinical trial monitoring at a minimum
  • Experience in creating, driving and overseeing clinical operations strategy
  • Working, in-depth knowledge of industry standards including ICH guidelines, GCPs and the CFR
  • Demonstrated, effective project management skills
  • Ability to assess complex issues and identify creative, practical solutions
  • Demonstrated success in meeting project timelines and budgets
  • Demonstrated success in identifying, negotiating and overseeing outsourced clinical operations services and vendors
  • Demonstrated ability to work independently as well as in a team environment
  • Excellent communication, writing and presentation skills

To apply for this job email your details to info@aldeyra.com