Associate Director, Clinical Trial Management

Planet Pharma; Brisbane (CA); Hybrid; USD 175,000 - 200,000; Full time

Job summary

Planet Pharma seeks an experienced Clinical Operations leader to oversee multiple multinational trials, including ophthalmology and neurology programs. You will manage budgets, vendor contracts, and study metrics, ensuring regulatory compliance and high-quality execution.

The role requires strong leadership, direct line management of clinical operations staff, and close collaboration with investigators and regulators. Travel up to 30% may be required.

Qualifications

• 10+ years leading clinical trial operations.
• Experience in ophthalmology, neurology, rare diseases.
• Strong leadership with direct line-management experience.
• Knowledge of FDA, EMA, ICH/GCP guidelines.

Responsibilities

• Oversee and execute multiple clinical trials.
• Develop and oversee vendor budgets and contracts.
• Track and report study metrics.
• Identify and mitigate risks to study implementation and enrollment.
• Develop relationships with investigators and key opinion leaders.
• Provide technical expertise for clinical documents (protocols, monitoring plans, reports, brochures).
• Stay current with therapeutic areas and FDA requirements.
• Coordinate with Regulatory, Clinical Development, Legal, Finance.
• Lead CRO/vendor selection for varied budgets.
• Attend vendor meetings to align goals.
• Contribute to Clinical Operations initiatives and best practices.
• Travel up to 30% to support study activities.

Skills

Leadership

Budget management

Vendor management

Regulatory knowledge

Cross-functional collaboration

People management

Education

BS/BA in related discipline

Job description

Responsibilities include:

• Accountable for the oversight and execution of multiple clinical trials including:


• Develop, implement, and provide oversight of vendor budgets and contracts


• Tracking and reporting of study metrics


• Identifyand mitigate risks to study implementation, enrollment, conduct, compliance, and completion


• Develop and manage effective working relationships with Investigators and other key clinical opinion leaders


• Provides technicalexpertisefor the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct


• Remains current with therapeutic areas under study, industry practices /trendsand FDA requirements.Applies this knowledgeto current programs


• Partners with andmaintainsregular contact with key stakeholders including Regulatory, Clinical Development, Legal, Finance, and others as necessary


• Leads the team in the selection of Contract Research Organizations (CROs) for both large budget and small budget


• AttendsCRO or other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals


• Contributes to definition, development, and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices


• Travel may be required to 30% in support of clinical study activities

Education, Experience, and Skills:

Required:

• BS/BA degree in related discipline or equivalent combination of education and experience


• 10+ years of experience leading clinical trial operations including multinational/multisite clinical studies with experience in ophthalmology, neurology, rare diseases, and overall drug development. Strong leadership skills with ability to be hands-on and lead/ manage the clinical team. Experience with direct line-management of clinical operations staff.


• Has a thorough knowledge of the clinical development process, FDA, EMA and other regulatory requirements that may impact global clinical studies as well as ICH and GCP guidelines


• Has demonstrated success identifying, negotiating and overseeing outsourced clinical operations services and vendors


• Experience with financial budgeting or reporting


• Ability to interact with investigators, vendors, and individuals at all levels of the organization

Base $175-200K based on experience level