Job Details

VP Clinical Operations and Regulatory Affairs

Title
VP Clinical Operations and Regulatory Affairs
Accepting BioReady
Yes
Length
Full Time
Employer

Sernova Corp.

Salary
not disclosed
Location
London, Ontario
Ontario
Date Posted
22/01/2019 - 18:45
Closing Date
22/02/2019 - 18:45
Job Description
Summary: 

Responsible for clinical trials operations and regulatory affairs.  Responsible for development, implementation and oversight of clinical research team managing clinical trials, clinical site management, the clinical monitoring process, and protocol development. Manages and provides strategic and tactical direction for Regulatory Affairs activities company-wide.  Ensures adherence to SOPs, Good Clinical Practice, FDA and international regulations. Responsible for clinical trials operations and regulatory affairs.  Responsible for development, implementation and oversight of clinical research team managing clinical trials, clinical site management, the clinical monitoring process, and protocol development. Manages and provides strategic and tactical direction for Regulatory Affairs activities company-wide.  Ensures adherence to SOPs, Good Clinical Practice, FDA and international regulations. Responsible for clinical trials operations and regulatory affairs.  Responsible for development, implementation and oversight of clinical research team managing clinical trials, clinical site management, the clinical monitoring process, and protocol development. Manages and provides strategic and tactical direction for Regulatory Affairs activities company-wide.  Ensures adherence to SOPs, Good Clinical Practice, FDA and international regulations.

 

Education & Qualifications: 

Pre-requisites/Job Experience

  • Master’s or Ph.D. degree in Life Sciences or a related field. 
  • Ten or more years of experience in clinical research and regulatory affairs, including 5 years of previous                    management experience

 

 
Experience: 
  • Experience with U.S. Class III (MDD) medical devices and/or biologics.
  •  Working knowledge of U.S. FDA, GCP and IDE/IND regulations.
  •  Extensive experience with all aspects of management of clinical trials from inception to completion.
  •  Experience in regenerative medicine (cell therapy) product studies a plus.
Duties & Responsibilities: 

Clinical Operations

  • Manages budgetary requirements and ensures compliance of expenditures to meet budget for clinical programs.
  • Oversees clinical trial operations, including management of Contract Research Organization (CRO), clinical staff, and consultants.
  • Facilitates Investigator Meetings, Core Lab processes.
  • Oversees clinical trial operations, including IRB/Ethics committee approval, the provision of clinical trial materials (control of study devices), and overall operations management of the trial.
  • Ensures that all aspects of GCP are complied with at all times for all aspects of clinical trial through training at start-up and initiation meetings for clinical trials and ongoing SOP development and implementation.
  • Coaches CRAs in various aspects of management (e.g. HR, budgets, resource allocation) that are relevant to particular project issues.
  • Implements training programs for CRAs and other contract clinical staff with topics that include:  principles and practices of project management, team communication, computer software and IT training, protocol and CRF writing, adverse event reporting.
  • Manages staff directing the development implementation and evaluation of clinical studies.
  • Directs the development of systems, practices and processes to ensure efficient and effective clinical operations including clinical trial management, data analysis, final study report and publication.
  • Represents the business medical professionals involved in clinical research with the Company.
  • Develops and fosters relationships with luminary physicians.
  • Collaborates with Marketing and R&D to organize workshops for meetings and regional company-sponsored symposia.
  • Monitors and reports on clinical performance of products and study status and outcomes. 
  • Provides input on competitive technologies. Provides training to clinical sites on product use, clinical procedures.

    Regulatory Affairs

  • Responsible for driving implementation of and continued compliance to global regulatory requirements, interprets and applies pertinent laws and regulations governing company products to meet business objectives.

  • Leads development, implementation and maintenance of regulatory processes at a company-wide level

  • Leads WW regulatory submissions for Class II and Class III medical devices and biologics.
  • Supports the development of regulatory strategies and application of the strategies to align with the business plans for a particular product
  • Actively works with R&D, Clinical Research, Marketing, Quality to ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across indications for US and International regulatory submissions.
  • Serves as main contact with US Food and Drug Administration (FDA) and liaises with other country Regulatory Agencies when needed, directly or in coordination with local country representation;
  • Demonstrates sound understanding of related fields (e.g., manufacturing, product / process development, quality assurance) and the ability to diverse problem solving.
  • Monitors the regulatory environment regionally/globally and provides assessments for the impact of new and changing regulations on the company’s areas of interest. Ensures new regulations or changes to existing regulations are communicated throughout the organization through company policies, procedures, and training.
  • Leads representation of Regulatory on project teams and partner with the cross functions on the team to ensure alignment of regulatory strategy and plans with the team objectives.
  • Supports and contribute into editing/revising Standard Operating Procedures.
  • Develops and support training for global regulatory processes and system implementations.
  • Builds team cohesiveness by leading, influencing, mentoring and motivating team members.
Skills & Competencies: 

Skills

  • Well organized, analytical and self-confident person.
  • Strong research abilities, experience conducting literature reviews, statistical analyses.
  • Strong communication skills and interpersonal skills, ability to coach and mentor
  •  Able to supervise/train internal resources (Associates), and external resources (contract monitors, etc.

Physical Requirements

  •  Extended periods of computer usage.
  •  Extended periods of sitting or standing.
  • Travel approximately 20-40%.