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Iovance Biotherapeutics
Remote, CA | Full Time
$219k-286k (estimate)
7 Months Ago
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Director Clinical Operations
$219k-286k (estimate)
Full Time | Scientific Services 7 Months Ago
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Iovance Biotherapeutics is Hiring a Director Clinical Operations Near Remote, CA

Overview

The Director, Clinical Operations, will lead and manage the assigned clinical operations team and have a key role in setting and executing departmental strategy.

Specific Responsibilities:

  • Oversees clinical trial agreements, budgets, expenditures and payments for clinical studies
  • Ensures the timely execution of clinical research programs/protocols from conception through final clinical study report. This will generally involve close supervision of external contract organizations who will have responsibility for site interaction, site monitoring, data management, biostatistics, IRB interaction, central laboratory function, clinical research budget negotiation, medical writing, pharmacovigilance, and other critical activities
  • Establishes and maintains good working relationships with clinical study site personnel to ensure adherence to protocols and Good Clinical Practice (GCP), provision of quality data and adherence to study timelines
  • Key contributor to the creation and implementation of clinical program feasibility and development plan
  • Key contributor to the preparation and management of clinical study protocols and protocol amendments
  • Works with VP, Clinical Operations and Senior Director, Program Management to develop detailed timelines and budgets for each clinical program to meet management goals
  • Assists with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc.
  • Contributes to the review of Investigator Sponsored Trials (ISTs) & the relevant documentation to support these trials.
  • Contributes to the creation of internal Iovance Biotechnologies SOPs & Clinical work practice documents and implementation of these plans for Clinical Operations to operate in accordance with FDA & EMA regulations
  • Interfaces with Chief Medical Officer/Medical Monitor and cross-functional team members including Data Management, Drug Safety, Logistics/Manufacturing, Project Management, Regulatory Affairs, and Biostatistics
  • Provide direct supervision of Clinical Operations team members, including performance management and development planning
  • Serve as company representative at external meetings, scientific congresses, etc.
  • Other duties as assigned

Education and Qualifications:

  • Bachelor’s Degree or Master’s in sciences, health, or related area (advanced degree, preferred)
  • 12 years of pharmaceutical or biotech-related/clinical research experience (oncology/ immuno-oncology experience required)
  • Demonstrated experience in core and technical aspects of leading phase 1-4 and supporting Investigator-initiated trials
  • Demonstrated success in managing clinical studies within timeline and budget
  • Demonstrated managerial skills and strong interpersonal and communication (verbal and written) skills in interacting with clinical monitors, investigators, and various individuals in specialized areas or internal groups to facilitate translational, clinical and correlative research
  • Able to build strong relationships with peers and partners both within and across functional teams to engage high performance
  • Able to assimilate information quickly, grasping critical factors and risks, while implementing immediate change where/when needed
  • Proven experience in using negotiating, influencing, and problem solving skills in order to meet study timelines
  • Able to set a high level of accountability and quality in deliverables
  • Proactive, self-directed, able to thrive and adapt in a rapidly changing environment
  • Embraces the ideas of others, promotes innovation and manages goals to reality
  • Flexible and dynamic approach to working in a fast-paced biotechnology company; willing to perform all necessary tasks, regardless of level, to facilitate success at driving a project/program to completion
  • In depth knowledge of PC operating systems; Microsoft Office, including MS Word, MS Excel, MS PowerPoint, MS Project, MS Publisher, MS Outlook, and MS Windows NT,
  • Exposure to CTM systems, EDC systems (eClinical, Medidata RAVE, InForm) and Safety/ Pharmacovigilance databases (ARGUS)
  • Available to travel up to 20% of the time

Physical Requirements:

  • Sit for an extended time in front of a computer

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice

Job Summary

JOB TYPE

Full Time

INDUSTRY

Scientific Services

SALARY

$219k-286k (estimate)

POST DATE

08/26/2022

EXPIRATION DATE

10/05/2022

WEBSITE

iovance.com

HEADQUARTERS

MANHATTAN, NY

SIZE

200 - 500

FOUNDED

2007

REVENUE

<$5M

INDUSTRY

Scientific Services

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