The Company

NodThera is a clinical-stage biotechnology company pioneering a paradigm shift in the treatment of chronic inflammatory diseases. Our focus is on developing a new class of potent, highly selective, and brain-penetrant NLRP3 inflammasome inhibitors. We have three therapeutic areas of focus: cardiometabolism, neuroinflammation, and peripheral inflammation. Of these, cardiometabolism is the highest priority as we advance rapidly through Phase 2 into Phase 3.

Unlike traditional approaches that block individual downstream cytokines, NodThera’s small molecules address the upstream catalyst of inflammation. With our lead candidate, NT-0796, we are uniquely positioned to address the “missing link” in cardiometabolic health: hypothalamic and systemic inflammation. Our recent data demonstrates that by resetting the body’s metabolic set-point and reducing inflammatory markers like hsCRP, we can deliver cardiovascular risk reduction that rivals other mechanisms with the additional potential of metabolic benefits.

Job Summary

We are seeking a Head of Technical Operations to join our team. This role will report to the CSO and have a high degree of visibility and expected impact across the organization. The successful candidate will bring a strong strategic and quality mindset to this leadership role with a proven track record managing risk and leading technical operations, including drug substance, drug product process, analytical development, and clinical manufacturing and supply. S/he will oversee and provide technical guidance, strategic direction, and long-range planning in the execution of all small-molecule CMC (Chemistry, Manufacturing and Controls) and related activities from IND-enabling studies to NDA with Phase 3 planning and supply chain experience. S/he will be responsible for and have experience with the development and implementation of efficient and effective CMC strategies, building CDMO relationships, integrating internal, external and virtual resources, and ensuring excellence in process and product development, including controls, and compliance with regulatory guidance. As a senior role, this individual will have access to members of the C-Suite on a regular basis and will play an integral role in tactical initiatives and strategic direction of the company.

Key Responsibilities

• Develop and implement a sustainable and adaptable CMC strategy for each clinical candidate and support business development of novel programs.
• Lead external CMC activities from IND-enabling studies to late clinical development (ultimately to NDA), ensuring full executive management engagement in key decisions and effective communications to all stakeholders
• Build or adapt the operational tools, systems, and communication channels necessary for alignment of the TO department with broader program teams, as well as Research, Clinical, Finance and Legal/IP, to achieve the corporate goals and quality objectives
• Lead, mentor and further develop the TO team with a strong team-based culture and commitment to scientific and operational excellence in alignment with individual, departmental, and corporate goals
• Provide input into the regulatory affairs strategy for the product portfolio; lead the development, review, and approval of all CMC sections in regulatory filings
• Participate in meetings with the relevant global health authorities, conveying the appropriate compliance with GMP and other standards
• Meet the needs of internal stakeholders for appropriately packaged and labelled clinical supplies through Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs)
• Oversee the review of all CMC-relevant documents, such as technical reports, batch records, protocols, and change controls to ensure compliance with all applicable regulations and industry standards for the development of drug substances and drug products
• Proactively identify potential risks to CMC timelines and deliverables and communicate/implement effective risk mitigation strategies
• Oversee management of external subject matter experts in the areas of CMC regulatory strategy, pharmaceutical development and manufacturing, and analytical development, and department budgets

Qualifications

• Minimum of 15 years’ experience in the Biotech / Pharmaceutical industry, ideally in a senior manufacturing and process development technical leadership role developing oral small molecules
• Minimum of 10 years managing a CMC function, modalities and experience in a small, virtual biotech preferred
• Experience leading multiple small molecule programs from IND enabling through late-stage clinical. Commercial experience would be a plus.
• Experience leading small molecule drug development and manufacturing across all CMC functional areas, successfully leveraging external partners (contract development and manufacturing organizations (CDMO) and Contract Testing Organizations (CTOs)
• Strong motivational team leader with excellent communication skills and an ability to work effectively with others, both cross functionally within the company, with consultants, and with external partners
• Hands-on leader who can build successful and sustainable processes, instill operational excellence, and work with and nurture the existing TO team
• Experienced in managing change in a growing organization
• Advanced (MS/MES/PhD) degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related technical discipline
• Demonstrated general ability applying fundamental scientific and engineering know how for crafting innovative and practical solutions to technical challenges
• Knowledge of cGMP regulations and CMC-relevant ICH guidance documents as well as experience in the preparation and defence of CMC regulatory documents
• Skilled in clearly conveying complex concepts and study results in written and verbal form to a range of audiences, such as peers, executive management, regulatory agencies, and intellectual property attorneys
• Highly motivated, ethical and professional self-starter with strong interpersonal skills and a quality and sense of urgency mindset, who is capable of influence and negotiation with stakeholders to successfully prosecute the completion of projects per timeline

Qualified candidates should email resume / CV to Recruiting@Nodthera.com