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. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. 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 therapeutic dose in the intended patient tissue.
Annexon is looking for an energetic and talented individual to join its lean legal team. Reporting to the VP, Legal and IP, the successful candidate will interact with all levels of the organization including executive management and be a crucial part of building out the legal infrastructure of a growing company, with an initial focus on the contracts function. The candidate will be expected to take the knowledge they have amassed at a national law firm and/ or in-house life sciences experience and apply it appropriately to a growth-stage company. The successful candidate will have significant experience handling the variety of contracts necessary for the startup and conduct of global clinical trials, and a willingness to expand into other substantive areas to support business needs.
Clinical and Manufacturing Contracts
- Draft and negotiate high-volume of specialized agreements necessary for the startup and conduct of clinical trials, including confidentiality, vendor/CRO services, clinical trial, investigator-initiated studies, informed consents and letters of indemnity.
- Ensure the consistent and timely delivery of high quality and compliant agreements while providing clear, practical and business-oriented guidance on all contracting issues through the entire contracting process.
- Establish strong, collaborative relationships with clinical department colleagues to support the training and education of internal clients on company policies and good contracting practices.
- Advise internal clients on contract interpretation, dispute resolutions and legal and business risk.
- May provide legal support for non-clinical contracting needs.
- Works with the VP, Legal and IP to develop and implement new contracts policies and procedures.
- Contributes to the establishment and ongoing improvement of contracting parameters and procedures, including template development across various jurisdictions worldwide and associated playbooks.
- Assist with ensuring contractual documents are processed and appropriately maintained in the company's contracts management system.
- Train and guide business teams on the use of contract templates, relevant legal issues, processes, and good contracting practices.
- J.D. degree from an ABA accredited law school; admission in good standing with any state bar (California preferred).
- At least 5 years of experience drafting and negotiating contracts, with a focus on clinical contracts, in the life sciences industry.
- Prior in-house experience as a member of a legal department in a biotechnology or pharmaceutical company is strongly preferred.
- Excellent written and verbal communication skills, attention to detail, good business judgement and the ability to work independently and as a member of a team, while meeting aggressive deadlines and juggling multiple matters at one time.
- Enthusiastic and resourceful.
- Process oriented with attention to detail and strong analytical thinking skills.
- Excellent communication skills, both verbal and written.
- Experience with biotech/pharma industry required.