Associate Director of Clinical Development Operations Project Management

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About the job

 Do you have 8+ years of clinical trials research experience? Are you looking for a new career opportunity?

Invenia Group are partnered with a large global biotech organisation focused on endocrinology and oncology, searching for an Associate Director of Clinical Development Operations Project Management, based out of their key US headquarters in California.

The incumbent for this role will directly lead the clinical sub teams, who are responsible for the implementation and execution of the development strategies for clinical development projects. This role will also be supporting clinical study and regulatory filing activities, timelines, and deliverables, and reporting into the Director of Project Management Development Operations.

Roles and Responsibilities:

The successful individual will be responsible for the following:

  • Manage the overall process of clinical programmes and schedule for all relevant clinical studies through phase 1 to 3
  • Delivery of the clinical development strategy and its related clinical and regulatory activities
  • Responsible for regulatory filings in collaboration with key functional stakeholders across the company.
  • Supports the clinical and regulatory sub-team teams in project planning, including timelines, budget, and resource management
  • Organize and oversee clinical and regulatory sub-team meetings to drive, track and mitigate risks, report and resolve issues, review action items, and document decisions in the execution of clinical trials and regulatory filings
  • Proactively assess and escalate risks and issues impacting the conduct of the trials, timelines, the management of the clinical data and regulatory filings.
  • Lead and contribute to project improvements and efficiencies in Development Operations’ initiatives & programs such as identifying areas of best practice, process improvements, development of SOPs & Wls, department level trainings.
  • Foster and promote strong interdepartmental collaboration, including facilitation of best practices and lessons learned sharing with all internal and external stakeholders affected by the project including project team, management team, end users, governmental/regulatory agencies, and vendors.

Skills and experience required:

We are looking for someone with a BA/BS or equivalent degree in a scientific discipline, as well as 8+ years of clinical trials research experience and clinical/regulatory project management within the pharma or biotech space. You should have a deep understanding of clinical operation, data management, safety, biostatistics, medical writing, regulatory filings and a ability to coordinate with and influence internal and external stakeholders to facilitate the advancement of projects at all stages.

You should be have the ability to support multiple project teams simultaneously under limited supervision, exceptional ability to manage changing priorities and ambiguity and openness to occasionally work irregular hours and travel internationally up to 10%. 

This is an excellent chance to join a dynamic global organisation in a highly varied role with great progression opportunities. If this sounds like something that would be in line with your skillset, please apply.