(EU) – Director – Clinical Operations (Ophthalmology) (Contract/ Consultant)

 

Work Location

EU, preferred location London, England

Position Summary

This position reports into the Executive Director of Global Clinical Operations. The Director – Clinical Operations (Ophthalmology) will contribute to the development and implementation of clinical studies. Interface with functional heads across Development and the rest of the organization to optimize planning efforts and communication. 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.

Responsibilities

• Accountable for the oversight and execution of multiple clinical trials.
• 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.

Qualifications

• BS/BA or MS/MA degree in related discipline or equivalent combination of education and experience
• Experience leading clinical trial operations as a Director/Senior Director or Executive/VP role including multinational/multisite clinical studies with experience in ophthalmology drug development.
• A minimum of 10 – 15 years of experience leading clinical trial operations including multinational/multisite clinical studies with experience in ophthalmology 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.
• Experience with Ophthalmology.
• 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. To learn more about our diversity commitment, culture and values, 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 (Nasdaq: ANNX) is 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. Annexon’s 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, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. To learn more visit annexonbio.com.

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.

 

Staffing Agencies

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.