Work Location: Corporate Headquarters (South San Francisco, CA) – Hybrid

Position Summary

This position reports into the Vice President / Executive Director of Global Clinical Operations. The Associate Director/Director/Sr. Director 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 an

• Accountable for the oversight and execution of multiple clinical trials including:
• Member of core team(s) providing strategic direction to study teams to meet corporate goals and timelines
• 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

Key Qualifications

• Experience leading clinical trial operations as an Associate Director, Director or Senior Director level role including multinational/multisite clinical studies with experience in rare diseases, immunology, neurology, and ophthalmology drug development.
  • Associate Director: Typically requires BS/BA degree 14 years of related experience, or MS/MA degree 12 years of related experience, or PhD 8 years of related experience.
  • Director: Typically requires BS/BA degree 15 years of related experience, or MS/MA degree 13 years of related experience, or PhD 10 years of related experience.
  • Senior Director: Typically requires BS/BA degree 17 years of related experience, or MS/MA degree 15 years of related experience, or PhD 12 years of related experience.
• 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

What Annexon offers

Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. We continuously work to build our pipeline of underrepresented candidates for our workforce, enhance, recruit and develop a best-in-class, diverse, equitable and inclusive workforce; ensure that Black, LatinX and other underrepresented candidates have long-term sustainable opportunities to work with Annexon; and hold our vendors to the same standards under which we operate. To learn more about Annexon’s diversity commitment, culture and values, please visit https://annexonbio.com/careers/

A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.

We are located in Brisbane, CA, with 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, as well as other benefits.

Company Summary

Annexon Biosciences is a clinical-stage biopharmaceutical company seeking to bring game-changing medicines to patients with classical complement-mediated diseases of the body, brain and eye. The classical complement cascade is a seminal pathway within the immune system that anchors and drives a host of autoimmune, neurodegenerative and ophthalmic diseases. Annexon is advancing a new class of complement medicines targeting the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of other complement pathways. Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late-stage clinical trials, with clinical data anticipated throughout 2023 and beyond.

EEO Employer – Annexon highly values Diversity, Equity, Inclusion and Belonging

Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status. We are proud to promote a work environment where everyone, from any background, can do their best work.

Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn’t have a signed agreement with Annexon Biosciences. Please do not send agency CVs/resumes through Annexon’s website or Annexon Employees. Inquiries must be sent to talentacquisition@annexonbio.com with the Subject Heading: Staffing Agency Request.