What are the responsibilities and job description for the Director/Senior, Clinical Program Management position at Adverum Biotechnologies, Inc.?
Adverum Biotechnologies, Inc. is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
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All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered Adverum's property. Adverum’s Talent Acquisition team must expressly engage agencies for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.
We are seeking a Director/Senior Director - Clinical Program Management who will oversee and drive the strategic planning, execution, and overall delivery of clinical programs across Adverum with a special focus on the Phase 3 studies for Ixo-vec. This role involves close collaboration with cross-functional teams, including Clinical Operations, Clinical Development, Regulatory, Data Management, Medical, and external partners, to ensure that clinical trials are conducted on time, within budget, and in compliance with regulatory standards. The ideal candidate will have a robust background in clinical trial management, strong program and project management skills, and a strategic mindset.
\n- Oversees clinical programs across Adverum, engaging with key functional representatives understand status and key risks, escalating accordingly
- Develops and implements overall clinical program management strategy across Adverum in collaboration with PMO Lead and Functional Leads
- Plans, aligns, communicates, and coordinates detailed and high level cross functional Ph3 study timelines
- Liaises with cross functional teams to ensure alignment with integrated Ph3 timelines and fit within overall program timelines
- Resolves timeline discussions as they arise – balancing team ability to deliver with study objectives and timelines
- Ensures all activities for Ph3 start up and operational timelines remain on track, escalating key risks and timeline clashes to program and functional leadership after gaining cross functional alignment on path forward
- Drives coordination of all team members to ensure timely planning, mapping, communicating, and completion of sequential and parallel activities
- Maintains critical path to key Study and Program milestones and ensures that target deliverable times are well defined and met
- Applies best practices for clinical conduct to all facets of study, coordinating with Clinical QA as needed
- Evaluates impact of changes to Ph3 design or strategy, whether driven by external or internal forces
- Manages forum(s) to monitor and ensure trial progress and cross functional alignment and awareness of key risks, tasks, and timeline elements
- Discusses regularly with cross functional PMO, ensuring planning alignment outside of clinical as necessary
- Bachelor’s degree in life sciences, healthcare, or a related field required. Advanced degree (MS, PharmD, or PhD) preferred.
- Minimum of 10-12 years of experience in clinical program management or clinical trial operations within the biotech, pharmaceutical, or CRO industry.
- Proven experience managing complex, multi-center clinical programs from initiation to close-out.
- Proficiency with project management tools and software, such as MS Project, GAANT charts or equivalent.
- Strong understanding of clinical trial regulations (FDA, EMA, ICH-GCP) and regulatory requirements.
- Ability to analyze and interpret clinical data and program metrics to inform strategic decisions.
At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space that allows for everyone in our Adverum Community to not only feel safe but also encouraged to speak, learn from each other, grow in their professions, and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation.
Salary : $216,000 - $250,000