Annexon Biosciences is a clinical-stage biopharmaceutical company pioneering the development of a new class of medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders. The company’s pipeline is based on its platform technologies addressing a broad spectrum of well-researched classical complement-mediated autoimmune and neurodegenerative diseases triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway. Annexon is deploying a disciplined, unbiased biomarker-driven strategy designed to improve the probability of technical success of its portfolio and striving to deliver precision medicine to patients with classical complement driven diseases in the body, brain and eye.
This position reports into the Vice President of Global Clinical Operations. The 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. Management and mentoring of direct reports (Director through entry level) is expected.
- 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
- BS/BA or MS/MA degree in related discipline or equivalent combination of education and experience
- A minimum of 10 years of experience leading clinical trial operations including multinational/multisite clinical studies with experience in rare diseases, immunology, neurology, and 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
- Ability to interact with investigators, vendors, and individuals at all levels of the organization
Annexon Bio is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Employment is conditioned upon full vaccination against the Covid-19 virus. An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine. You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws.
Recruitment & Staffing Agencies: Annexon Bio does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Annexon Bio or its employees is strictly prohibited unless contacted directly by the HR Team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Annexon Bio, and Annexon Bio will not owe any referral or other fees with respect thereto.