Work Location
Corporate Headquarters (South San Francisco, CA) Onsite - Hybrid
Position Summary
This position reports into the Vice President of Global Clinical Operations. The 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 and vendors. The Sr. Director will contribute Clinical Operations expertise in cross-functional meetings and develop and implement department initiatives. This position may also be responsible for people/team management and mentoring of indirect or direct reports.
Responsibilities
- 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
Requirements
- Experience leading clinical trial operations (as an AD/Director/SD role) including multinational/multisite clinical studies with experience in rare diseases, immunology, neurology, or 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. 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.
Compensation
The anticipated starting salary range for the . The starting salary for this position will be determined based on the candidate’s education, experience, transferable skills, licenses/certifications, location, and will be reviewed on a case-by-case basis to determine the final compensation. The starting salary does not include any other potential components of the total compensation package, including bonus, equity, employer provided benefits, and perks.
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.
