Director/Senior Director, Clinical Operations

Location
San Francisco, CA
Posted
Nov 30, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Description

The Director, Clinical Operations, is responsible for leading the overall clinical operations activities across all clinical studies for a clinical development program. Responsibilities include: clinical operations representative on Product Development Teams, leading clinical sub-teams, project and trial planning, budgeting and financial oversight, staff and contract research organization (CRO) management, program/trial clinical operation, timelines and GCP compliance.

In addition, the Director of Clinical Operations will assist in the development of staff and infrastructure, as well as resource allocation across programs and trials, and create a positive and productive work environment for attracting and retaining highly qualified clinical operations professionals.  

 Responsibilities:

  • As the clinical operations representative for development programs; oversee functional deliverables to support program objectives as defined in the clinical development plan; identify risks, communicate risk mitigation plans, and escalate risks and risk mitigation strategies to the clinical operations function head appropriate
  • Represent clinical operations on Product Development Teams and any sub- teams, or ad hoc committees as needed or requested
  • Ensure ongoing strong vendor interactions and collaborations, including hands-on interactions and management 
  • Develop and present development plans and budgets for planned and ongoing trials to Senior Management
  • Line management responsibilities include hiring talent, performance development and mentorship
  • Ensure that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards
  • Lead and/or participate in developing and drafting protocols, amendments, CRF, informed consent forms, Investigator Brochures, IND annual reports, and other documents as needed or requested
  • High level oversight of trial monitoring data, i.e., flow from the sites (CRF completion) to data entry (CRF’s entered in database) to data listing review
  • Responsible for ensuring compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines
  • Collaborate with clinical staff to develop and support departmental initiatives to ensure operational consistency across multiple programs
  • Develop work processes which enhance the cross functional effectiveness of clinical operations with other functions such as clinical/medical, medial affairs, biostatistics, data management, CMC, regulatory, finance, legal and business development

   Qualifications:

  • BS/MS in a scientific discipline or equivalent experience with a minimum of 12 years clinical operations experience in the pharmaceutical/biotech industry, with at least 5 years direct line management experience.
  • Experience working with Academic Research Organizations (ARO)
  • Experienced in trial initiation activities for global Phase 3 studies, including vendor selection, region and site selection activities, database design, establishment of relevant study plans, organizing Investigator Meetings, and developing timelines and communication tools for use with upper management
  • Experience with data surveillance and signal detect through analytics of datasets using Excel or SAS a plus
  • Experience working on complex studies involving biomarkers and activities across multiple vendors
  • Knowledge and experience with developing, negotiating and managing contracts (vendor and site)
  • Experience in study close-out activities, including data review and data base closure, site closure, TMF/inspection readiness, and supporting production of final CSR
  • Regulatory inspection experience a plus
  • Demonstrated excellence managing multiple projects/priorities
  • Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials
  • Experience in developing RFPs, selection of CROs/vendors, and management of external resources
  • Demonstrated ability to manage international clinical trials within designated program budgets and timelines
  • Demonstrated independence, problem-solving abilities, self-motivation, resourcefulness and ability to work in a fast paced team environment
  • Experience with building clinical operations infrastructure including writing of SOPs
  • Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing
  • Thrombosis/Immunology experience a plus