Clinical Operations Director

3 weeks ago

North Sydney Council, Australia InClin Full time
About the Role

InClin, a boutique Contract Research Organization (CRO) with offices in the US and Australia, is seeking a highly skilled and experienced individual to join our Australian office as an Associate Director, Clinical Operations.

Key Responsibilities
  • Provide operational and implementation expertise to the Clinical Operations Department and report directly to the Vice President of Clinical Operations.
  • Lead project teams as a Project Director and/or function as a Project Manager for specific projects, supporting Business Development activities.
  • Provide line management support for the Clinical Operations Department.
Main Responsibilities
  • May serve as Project Director or Project Manager/Lead CRA for InClin project teams.
  • Operate at a strategic level, including input into risk management plans, department process improvements, and therapeutic area/indication expertise.
  • Provide guidance and mentorship to Clinical Staff as appropriate on specific activities and approaches to execute work.
  • Contribute to the development of critical plans, including scenario planning, high-level forecasting of timelines, estimation of resources and budget, and development of operational strategies.
  • Handle unique challenges and decisions that have an impact on Clinical Operations.
  • Provide innovative and flexible operational solutions.
  • Maintain internal consistency across clinical operations teams.
  • Collaborate effectively with internal and external partners.
  • Participate in the development of clinical operations performance standards.
  • Participate in the selection, onboarding, and line management of Clinical Operations staff.
Requirements
  • BA/BS or Advanced degree (Masters/PhD), in the sciences.
  • Highly advanced knowledge of the Clinical development process.
  • At least 12 years of relevant clinical Pharmaceutical, Biotechnology, Device or CRO experience.
  • 5 years of direct Line management experience.
  • Prior site experience considered beneficial for either CRA-Field monitoring or CRC.
  • Prior CRO experience preferred.
  • Experience in execution of complex clinical trials ranging from Phase 1 studies to large multi-center global programs.
  • Well-versed in GCP and applicable FDA/EMA regulations required.
  • Ability to present clinical trial and departmental updates to senior management.
  • Ability to manage client relationships.
Knowledge and Skills
  • Able to incorporate a broad understanding of industry issues into plans/strategies to capitalize on ideas and initiatives that will drive the success of the Clinical Operations department now and in the future.
  • Able to consider how present policies and practices might be affected by future developments and trends within the global regulatory and compliance landscape.
  • Effective in building relationships and networks across and beyond InClin.
  • Able to compile, analyze, and present data in a concise manner, in both written and oral context.
  • Demonstrate ability to enlist input from stakeholders to make key decisions (e.g. tactics to accomplish goals), while ensuring final decisions are reached quickly and effectively.
  • Able to provide both performance feedback to direct reports and staff who may report to others.
  • Able to identify development opportunities for Clinical Operations staff.
  • Comfortable stretching people to help them grow.
  • Outstanding verbal and written communication and interpersonal skills.
  • Dynamic presentation skills, including command of the English language.
  • Ability to effectively work under pressure within tight timelines.
  • Strong computer skills (MS Office and project planning software).
  • Ability to travel as required (~25%).

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