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Associate Director Clinical Operations

Employer
mexec
Location
Melbourne, Australia
Salary
Competitive
Start date
25 May 2023
Closing date
9 Jun 2023

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Discipline
Clinical Research, Clinical Operations
Hours
Part Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

  • Oncology
  • Part Time or Full Time
  • Melbourne

Our client is an Australian & UK based drug discovery and development company focused on developing novel immuno-oncology agents. Founded by experienced industry professionals, you will be joining an international team that brings proven success in the delivery of revolutionary drugs. Working with leading academic and commercial drug discovery and development partners, they are delivering first-in-class clinical candidates against strongly validated targets.

The Opportunity
Your remit will be to manage the study execution and provide input as well as operational oversight to CRO partners, leadership, and management of our client's clinical studies. You will provide local/regional expertise, contribute to the overall operational strategy, and oversee capabilities (internally and externally) required to deliver clinical research. You will be an experienced and pragmatic innovator that will confidently and persuasively interact with investigators and CRO partners, as well as work independently and proactively within a cross-functional global study team.
  • Lead local/regional study execution activities related to the development of technologies.
  • Actively participate in the Study Team to implement and oversee a nimble and efficient operating model for clinical trial activities, working with key internal stakeholders, 3rd party vendors/CROs and establishing appropriate systems and infrastructures to ensure timely and compliant delivery of goals.
  • Input into trial design and translate scientific imperative into operational delivery of trials.
  • Review protocols, study plans, IP management plans, CSRs and other trial-related documentation.
  • Advise regarding the development of IND/Clinical Trial Authorisation (CTA) and ethics committee packages and documentation, in alignment with related objectives and regulatory requirements.
  • Partner closely with CRO(s) to build excellent working relationships and communication, and effective quality oversight and documentation.
  • Proactively identify risks pertaining to clinical trial execution, providing actionable plans and mitigation strategies.
  • Develop and maintain effective relationships with investigators and clinical sites locally, including some site visits.
  • Participate in investigator meetings/webinars, coordinating relevant expert and team input locally in conjunction with CRO partner(s).
  • Provide guidance on protocol and procedures in the development of eCRF design and data management activities.
  • In conjunction with global team, review clinical trial data - monitor data quality and ensure appropriate quality measures are in place.
  • In collaboration with CRO partner, ensure TMF completion and inspection readiness.
  • Assist global team to build local clinical operations capability as needed, in line with the company's growth strategy.
  • Ensure compliance with all applicable industry regulatory standards and partner with Quality team to support and maintain a strong quality mindset and culture.
  • Assist Head of Clinical Operations with the planning and management of budgets for clinical trial activities in line with the business needs.
Position Requirements
  • BSc/ PhD in a relevant scientific discipline.
  • At least 5 years of clinical research experience in industry (Pharma, biotech or CRO) preferably in Phase 1-3 oncology/immunotherapy drug development.
  • A broad understanding of drug development including CMC, Regulatory, Safety and non-clinical activities.
  • Demonstrated track record of clinical trial delivery across the product lifecycle but strong preference for candidates with early clinical development experience.
  • Experience of successfully leading trial site and CRO interactions.
  • Proven capability to innovate and guide trial activities where pathway is not well defined and bespoke solutions are required.
  • Experience in a fast-paced, entrepreneurial, high-growth environment.
  • Be comfortable assimilating sometimes ambiguous information and comfortable working on high-risk programmes.
  • Excellent communication skills both verbal and written; flexibility to adapt to communicating across all stakeholder groups.
Our Offer
Title: May include Local Study Manager Associate Director or Director of Clinical Operations.
Salary: Will be based on the level of experience.
Part time: The preference for this role is to be part time however if you bring expertise that would be valuable in other parts of the business you may be considered for a full time opportunity.

Our client offers an exceptionally dynamic and progressive work environment that is at the leading edge of new drug development.

To join our client in this exciting opportunity please email your cover letter & CV to careers@mexec.com. Confidential enquiries to Marilyn Jones or Mark Thomas on 1300 0 MEXEC.

mexec delivers executive recruitment solutions to the pharmaceutical, biotechnology and broader technology industries. mexec comprises of highly talented and knowledgeable industry experienced Consultants that partner with leading organisations to grow their leadership teams.

We recruit at all levels including senior management, and we are currently recruiting for a variety of opportunities in the area of Sales & Marketing, Management, Medical, Regulatory Affairs, Clinical Research, Pharmacovigilance and Operations. Contact us today.

Company

Find out more about working for our company

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Brief Company Description; 

mexec is an Executive Search Recruitment firm that also provides support to individuals seeking to transition to a new role. 

We specialise in the science, health and innovation sectors. 

mexec are experienced in resourcing staff for companies including executive search and selection services to build your leadership team. 

We offer comprehensive services for individuals including our mexec jobstrategyTM program, résumé writing, LinkedIn profile updates and interview coaching. 

mexec works at all levels from graduate to CEO and board.

 

hub-icon-mexecPlease visit our Careers Hub on https://www.pharmiweb.jobs/minisites/mexec-agency-careers-hub/

 

 

 

Company info
Website
Mini-site
mexec
Telephone
1300 0 63932
Location
16 Harold Street
Blackburn
VIC
3130
Australia

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