Associate Director, Clinical Operations

at  InClin

InClin Inc., a boutique CRO with offices in the US and Australia is looking for a dynamic individual to join our Australian office!

JOB DESCRIPTION / SUMMARY

The Associate Director, Clinical Operations will provide operational and implementation expertise to the Clinical Operations Department and report directly to the VP of Clinical Operations. This individual will be responsible for providing Sr. level oversight to project teams as a Project Director and/or function as a Project manager for specific projects, supporting BD activities (RFI, RFP, Bid Defense, Budgets, Change Orders, BD travel to visit current or prospective clients, scientific or industry meetings to promote InClin). S/he will also provide line management support for the Clinical Operations Department.

EDUCATION AND EXPERIENCE 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 & SKILL REQUIREMENTS

• 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%)

The main responsibilities of this role include but are not limited to the following:

• 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
• Maintains 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