Annexon Biosciences

Associate Director, Clinical Trial Management

Annexon Biosciences • $179K — $200K *
San Francisco, CA 94112In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • BS/BA degree in a related discipline or equivalent education and experience.
  • 10+ years leading clinical trial operations, including multinational/multisite studies, particularly in ophthalmology, neurology, and rare diseases.
  • Strong leadership skills with hands-on experience in managing clinical teams.
  • Thorough understanding of clinical development processes and regulatory requirements (FDA, EMA, ICH, GCP).
  • Demonstrated success in managing outsourced clinical services and vendor relations.
  • Financial budgeting experience for clinical operations.

Responsibilities

  • Oversee and execute multiple clinical trials effectively.
  • Develop and manage vendor budgets and contracts meticulously.
  • Track and report on study metrics consistently.
  • Identify and mitigate risks related to study implementation and compliance.
  • Build and maintain strong relationships with Investigators and clinical opinion leaders.
  • Provide expertise in clinical document development and trial conduct.
  • Stay updated on therapeutic areas, industry practices, and FDA requirements.

Benefits

  • Flexible work schedules and remote work opportunities for better work-life balance.
  • Convenient shuttle service from major transit points.
  • Comprehensive health benefits including medical, dental, vision, and 401(k).
  • Employee stock purchase plan and equity participation opportunities.
Full Job Description
Position:

The Associate Director of Clinical Trial Management 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 Associate Director will contribute Clinical Operations expertise in cross-functional meetings and develop and implement department initiatives. Management and mentoring of direct reports (Manager through entry level) is expected. This position reports into the Executive Director or VP of Development Operations.

Responsibilities include:
  • Accountable for the oversight and execution of multiple clinical trials including:
  • 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

Education, Experience, and Skills:

Required:
  • BS/BA degree in related discipline or equivalent combination of education and experience
  • 10+ years of experience leading clinical trial operations including multinational/multisite clinical studies with experience in ophthalmology, neurology, rare diseases, and overall 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

Salary Range: $179,000 - $200,000

Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area.

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

About Annexon Biosciences

Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, eye and brain. The company's pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is advancing a portfolio of product candidates into clinical development, including its lead program, ANX005, for the treatment of Guillain-Barré Syndrome and Warm Autoimmune Hemolytic Anemia. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated exposure level, enabling the company to continue development with a high level of confidence in its approach.
Learn more about Annexon Biosciences
Size
30 employees
Market Cap
$917
Industry
Pharmaceuticals & Biotech
Founded
2011
NASDAQ
ANNX
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Annexon Biosciences

More Pharmaceuticals & Biotech Jobs

Find similar Associate Director, Clinical Trial Management jobs:

NationwideSan Francisco, CA