Associate Director Clinical Operations

Oncology
- Part Time or Full Time
- Melbourne

**Our Client**

**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.
- 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.

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.

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