Associate Director, Clinical Trial Management

Annexon Biosciences • Brisbane, CA

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About The Position

The Associate Director of Clinical Trial Management will contribute to the development and implementation of clinical studies. Responsibilities include providing leadership to staff and study teams to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements. Establish and lead meetings with CROs and other trial vendors and serve as a key escalation point for teams and vendors. The Associate Director will contribute Clinical Operations expertise in cross-functional meetings and develop and implement department initiatives. Management and mentoring of direct reports (Manager through entry level) is expected. This position reports into the Executive Director or VP of Development Operations.

Requirements

• 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

Responsibilities

• 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
• Identify and 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 technical expertise for 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 / trends and FDA requirements. Applies this knowledge to current programs
• Partners with and maintains regular 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
• Attends CRO 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 up to 30% in support of clinical study activities

Benefits

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• Shuttle service from BART, CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director