Annexon Biosciences is creating and developing proprietary therapeutic products that modulate the classical complement pathway. Our pipeline is based on breakthrough research showing that the initiating molecule of the classical pathway, C1q, stimulates an immune-mediated attack that causes cell loss and tissue damage in a broad array of autoimmune, neurodegenerative and ophthalmic disorders.
Annexon’s most advanced programs modulate C1q, the initiator of the classical complement pathway. Through targeting the classical complement pathway, Annexon is developing novel approaches to treat autoimmune, ophthalmic and neurodegenerative disorders.
The Director/Senior Director Clinical Contracts and Outsourcing will play an integral role in the oversight and relationship management of Annexon’s clinical vendors. He/She will be responsible for ensuring that the relationship between Annexon and its strategic vendors is running efficiently and productively. As a leader within the organization, they will be instrumental in the concept, design, growth and deliverables of clinical trial execution as it relates to external vendor partnerships to assure the highest quality delivery of Clinical Programs, on time and within budget. Reports to Vice President, Global Clinical Operations.
· Point person for clinical contracting.
· Partner with stakeholders to provide support and expertise in developing clinical vendor contracts, budgets, and proposals.
· Develop and cultivate excellent internal cross-departmental and external service provider relationships to enable the advancement of clinical development programs.
· Generate Requests for Information (RFIs), Requests for Proposals (RFPs), and budget grids/trackers for clinical trials, and assist Clinical Operations Management with the service provider selection process including bid comparison analysis.
· Facilitate and execute bid defenses and proposal review meetings.
· Negotiate final scopes of work, budgets, and payment schedules, with input from cross-functional stakeholders, for clinical study service providers.
· Negotiate change orders and ensure service providers adhere to contract terms.
· Review invoices against vendor contracts and interfaces with Clinical Operations staff to ensure accuracy and satisfactory completion of deliverables.
· Manage the contract negotiation process and contract lifecycle management in collaboration with Legal department.
· Partner with Clinical Operations and Finance regarding month-end and budget/forecasting needs, such as accruals, project budgets, clinical trial budgeting models and what-if scenarios etc.
· Work closely with Clinical Operations to measure and report quarterly service provider performance.
· Facilitate and execute supplier governance meetings and reviews. Assist management with audits of contract and sourcing records to ensure accuracy and completeness.
· Support the development, improvement, and implementation of processes and tools related to outsourcing activities including a database for identifying and maintaining current and potential service providers.
· BA/BS in related discipline required; a combination of relevant education and applicable job experience may be considered. MBA or JD a plus.
· Minimum of 8-10 years of related experience at a CRO, Biotechnology or Pharmaceutical organization.
· Well-versed in clinical contract terms, CRO bid/selection process, contract negotiation, monitor performance and invoicing.
· Demonstrated capability of managing multiple external vendors for multiple clinical trials simultaneously.
· Demonstrated leadership qualities and strong influencing skills, including ability to prepare/negotiate external provider master service agreements, work/change orders, and track expenses for clinical operations.
· Must possess strong business judgment and a strong understanding of RFI/RFP development, proposal evaluation, and contract and budget management.
· Customer service oriented; works effectively in a matrix cross-functional environment.
· Must have the ability to interact with clinical teams, project management, corporate finance, and Legal to provide oversight of service provider performance and clinical payment management activities.
· Excellent communication skills, (verbal and written) including the ability to understand and present budget information effectively.