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 Huntingtons 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 youll 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.

Were seekingexceptional talent from all backgrounds to fuel our growth. At Annexon were building a diverse equitable and inclusive workplace. We value unique perspectives and unconventional paths. If youre the best candidate for the job even if you dont perfectly fit the traditional mold we encourage you to more about our commitment to diversity equity inclusion and our companyculture!

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
• 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 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 berequiredup 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

Salary Range: $179000 - $200000

Location:Annexon Biosciences is located in Brisbane California and preference is given to candidates in the San Francisco Bay Area.

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.

Annexon Biosciences is an Equal Opportunity Employer and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths views and experiences. We believe that our differences enable us to be a better team one that makes better decisions drives innovation and delivers better business results. Creativity and innovation flourish in an environment of openness inclusion and mutual respect.