The Associate Director of Clinical Trial Management will lead and oversee the execution of multiple clinical trials at Annexon Biosciences, ensuring compliance with protocols, SOPs, GCPs, and regulatory requirements. This role plays a central part in driving clinical operations, managing vendor relationships, leading cross-functional initiatives, and serving as a key escalation point for clinical teams and external partners.
What You'll Do
- Accountable for the oversight and execution of multiple clinical trials
- 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
What We're Looking For
- 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
Team & Environment
- Reports to: Executive Director or VP of Development Operations
Benefits & Compensation
- Flexible work schedules
- Remote opportunities
- Ability to achieve a work-life balance
- Shuttle service from BART, CalTrain and the Ferry
- Competitive base salary
- Equity participation
- Employee stock purchase plan
- Comprehensive health benefit package that includes medical, dental, vision
- 401(k)
- Flexible spending plans
- Other benefits
Compensation includes a salary range of $179,000 - $200,000, equity participation, and access to an employee stock purchase plan and bonuses as part of a competitive total compensation package.
Work Mode
Hybrid work model based in Brisbane, CA, with flexible work schedules and remote opportunities available. Preference is given to candidates in the San Francisco Bay Area.
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.
