Director/Senior Director/Executive Director, Portfolio Strategy & Operations

Company Summary

Annexon (Nasdaq: ANNX) 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. 

Work Location:  Hybrid - Remote assignment may be considered

Position Summary
The selected individual is responsible to 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. Incumbent will provide 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.

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

Key Qualifications:

• BS/BA or MS/MA degree in related discipline or equivalent combination of education and experience
• A minimum of 8-10 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 Biosciences requires that all employees be fully vaccinated 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.

DIVERSITY, EQUITY, INCLUSION, 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.

Internally, we want to make sure all employees feel welcome, appreciated and can be themselves at Annexon. We continually educate, inform and hold accountability for improving our diversity, equity, inclusion and belonging efforts. We ensure that open and real dialogue happens on important diversity topics.

Externally, 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 businesses have long-term sustainable opportunities to work with Annexon; and hold our vendors to the same standards under which we operate.

The anticipated starting salary for the Senior Director level Global Clinical Operations position is $247,000 - $275,000 per year. The starting salary for the Executive Director Global Clinical Operations position is $270,000 - $300,000. 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.

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 doesn't 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.