Assistant Director, Clinical Operations

Location
Philadelphia, PA
Salary
Negotiable
Posted
Dec 21, 2018
Ref
VAR OP 20181221A
Required Education
Bachelors Degree
Position Type
Full time

Assistant Director, Clinical Operations

Company Description:

Variant Pharmaceuticals is developing a novel therapeutic agent for the treatment and management of glomerular disease. Our agent is designed to improve proteinuria and delay the progression of renal impairment in rare diseases.  Our agent, 2 hydroxypropyl beta cyclodextrin, has its effect on lipid membranes, and is thought to have an effect on cholesterol efflux, improving and repairing podocyte functionality in the glomerulus. 

Reporting to the Chief Scientific Officer/Vice President, Research and Development, the qualified individual will have a demonstrated success in the management of multicenter clinical studies and will oversee all clinical trials within the development group. As the integral member of Clinical Operations, the incumbent will work closely with the CSO and with CROs to ensure that all assigned operational trial deliverables are met according to timelines, budget, operational procedures, quality standards, SOPs and business guidelines. The incumbent will work independently and collaboratively in a variety of clinical meetings, projects, and tasks.

Scope of Work and Responsibilities:

  • Responsible for the successful management of rare disease clinical programs through the day-to-day management of CRO’s and vendors.
  • Acts as a liaison between CROs and establishes quality guidelines to ensure CROs are meeting standards in accordance to Variant’s SOPs
  • Provide direction and leadership in CRO and Vendor selection and management
  • Develop working relationships with CROs, key investigators, and other key staff/vendors
  • Develop and manage clinical budgets
  • Provide technical expertise for the development of clinical documents (protocols, study plans, and trial conduct)
  • Serve as a leader to proactively monitor and inspect clinical operations activities for efficiency, quality, and progress
  • Work with finance to develop budget forecasts, and review accruals for clinical studies
  • Collaborate with staff and vendors to identify and evaluate study investigators and sites
  • Monitor the study progress, data collection, and close-out for all trials
  • Review and approve monitoring reports, study reports and project updates
  • Develop best practices and SOPs as needed

Qualifications and Professional Skills:

  • Bachelor of Science Degree
  • 8+ years of relevant clinical operations experience
  • Experience with NDA and/or BLA submissions
  • Familiar and comfortable with clinical operations concepts and operational practices and needs
  • History of successful management and interaction with CROs, vendors, and other external clients
  • Proven team member that can work unilaterally and collaboratively
  • Detail oriented and able to guide clinical operations improvements in a growing company
  • Experienced in FDA regulations and other international regulatory agencies
  • Proficient with Microsoft Office
  • Self-starter with a positive work ethic

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities.

Variant Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law.

Summary

  • Position: Assistant Director, Clinical Operations
  • Job Type: Full-time
  • Experience: Relevant clinical operations experience in Pharmaceuticals/Biotech: 10 years
  • Education: Bachelor of Science (minimum)
  • Location: Philadelphia, PA metropolitan area