Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. 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.
Desired Candidate Profile
The Associate Director/Director, 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 Associate Director/Director, Program & Portfolio Management will work closely with the GPL (Global Program Leader) to help establish and execute program strategy and activities, integrate cross-functional input, synthesize team recommendations, and ensure program advancement on time and on budget. Lastly, the Associate Director/Director, Program & Portfolio Management is expected to create and maintain consistent project documentation including project plans, timelines, trackers and communications.
- In partnership with GPL and Core Team, develops and maintains integrated product development and lifecycle plans.
- Creates and maintains project timelines that are critical tools for tracking progress against goals; closely and transparently manages the critical path of the project.
- Proactively identifies critical milestones, interdependencies, risks and resource constraints that could impact project timelines and collaborates with teams to develop appropriate solutions.
- Co-facilitates Core Team Meetings with GPL.
- Responsible for Core Team documentation including meeting agendas, minutes, action item and decision trackers.
- Ensures that all team members are fully informed and knowledgeable of project activities and status; optimizes communication within and between teams, in and outside of meetings.
- Partners with Core Team to proactively address acute issues that arise.
- Ensures that consistent project management tools and practices are used across team.
- Supports continuous improvement efforts in Project Management practices at Annexon; leads department initiatives.
- Ensures compliance with corporate policies and procedures, as well as US healthcare laws and regulations.
- Undergraduate degree in a scientific, medical or business discipline; postgraduate qualification (e.g., Ph.D., MBA, MS) or commensurate experience is a distinct advantage.
- A minimum of 8 years of biopharmaceutical industry experience, with half in a Project Management function supporting highly matrixed drug development teams comprised of, but not limited to, functional area representatives from Research, CMC, Regulatory, Clinical, Marketing and Finance.
- Solid understanding of activities critical to early and late-stage drug development projects; commercial-stage a plus.
- Proven ability to manage complex, cross-functional development projects with Go/No Go decisions.
- Well-versed at scenario planning and capable of rapidly integrating new information into existing plans.
- Excellent meeting planning and facilitation skills.
- Highly proficient at both building and maintaining Gantt charts, tracking systems, spreadsheets and tools that support a systematic and scalable approach to managing projects.
- Highly organized, excellent writing and oral communication skills, motivated and analytically rigorous.
- Experienced at partnering with team members to determine planning assumptions that drive timelines and budgets.
- Adept at skillfully managing complex and challenging situations, including driving to clarity.
- Team-oriented, with excellent interpersonal skills (i.e., collaboration, conflict management and negotiation).