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.

Manager/Senior Manager – Clinical Outsourcing (CONTRACT)

Responsible for supporting Clinical Development Outsourcing department in coordinating and managing service provider needs for current and future clinical trials, including vendor identification, RFPs, vendor selection, budget and contract negotiations, and assisting with management of study budgets.

Location: Remote assignment will be considered.

Responsibilities:

• Manages the identification and selection process of clinical vendors such as CROs, central labs, Imaging, data management, biostatistics, etc.
• Generates Requests for Information (RFI) and Requests for Proposals (RFP) and budget grids
• Coordinates bid defenses and proposal review meetings and provides analysis to project teams as needed
• Manages operational aspects of clinical contracts and change orders, including active negotiation of scope of work, payment terms and budgets
• Partners with functions within Clinical Development and Finance in maintaining study budgets and assisting with forecasting process
• Partners with suppliers and internal staff to identify, manage, escalate and resolve issues related to supplier performance and participates in governance meetings as needed
• Continually identify opportunities to reduce costs, increase efficiency, optimize service provider relationships and value, and mitigate risk
• Provide input to clinical development plans including clinical trial financial modeling and scenario planning
• Maintain and update GrantsPlan, upload site budgets to database
• Track supplier contract timelines and initiate renewal process as needed

Key Qualifications:

• 5+ years in biotech/pharma clinical research industry; 3+ years clinical outsourcing
• Strong understanding of outsourcing and contracting best practices for all phases of clinical research with an understanding of the drug development process and the cross-functional responsibilities including clinical trial design, study start-up and execution, CRA and site management, safety reporting, data management, and biometrics
• In-depth experience soliciting and critically evaluating CRO and service provider proposals, negotiating SOW terms, and growing and fostering long-term, healthy strategic relationships
• Strong interpersonal, communication and presentation skills to be able to engage with cross-functional teams and clinical service providers/CROs
• Forward-thinking and creative with high ethical standards
• Ability to work in a fast-paced environment with drug development professionals
• Strong problem-solving skills
• Ability to lead and manage cross-functional initiatives from concept to completion
• Experience with Grants Plan a plus

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 colleagues 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 hourly rate for is this position is $70 to $95 per hour. The hourly rate 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.

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.