Associate Director, Clinical Trial Management

Company:

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.

For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.

We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture!

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.

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
• 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

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