Aldeyra Therapeautics, Inc.

Position Summary:

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