Manager/Sr. Manager, Clinical Outsourcing and Business Operations (CONTRACT)

Work Location: Brisbane, CA (Hybrid)

Position Summary

The Director/SD/ED, Program & Portfolio Management is a proactive and effective problem solver who is intellectually curious and works exceedingly well with others. This role is responsible for managing and driving cross-functional activities required to advance a program from preclinical development through BLA or NDA submission. The winning skill set includes working effectively and efficiently with cross- functional groups including nonclinical, clinical, technical development, regulatory, manufacturing, commercial planning and finance. As a key member of the Core Team, the Director/SD/ED, Program & Portfolio Management will work closely with the Project Team Leader (PTL) to establish and execute program strategy and activities, integrate cross-functional input, synthesize team recommendations, and ensure program advancement on time and on budget. The candidate will also facilitate and lead discussions, and drive to solutions.  Lastly, the Director/SD/ED, Program & Portfolio Management is expected to create and maintain consistent project documentation including project plans, timelines, trackers and communications.

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 

What Annexon offers

• Diversity, Equity, Inclusion, and 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. 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 candidates have long-term sustainable opportunities to work with Annexon; and hold our vendors to the same standards under which we operate. To learn more about Annexon’s diversity commitment, culture and values, please visit https://annexonbio.com/careers/
• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• We are located in Brisbane, CA, with 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, as well as other benefits.

Compensation

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. 

Company Summary

Annexon Biosciences 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.

EEO Employer – Annexon highly values Diversity, Equity, Inclusion and Belonging

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 does not 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. Please do not send agency CVs/resumes through Annexon’s website or Annexon Employees.  Inquiries must be sent to talentacquisition@annexonbio.com with the Subject Heading: Staffing Agency Request.