Tvardi is a privately held, clinical-stage biopharmaceutical company developing small molecule inhibitors of STAT3. STAT3 is a key regulatory protein positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells as well as to the pathogenesis of many inflammatory and fibrotic diseases. STAT3 has long been recognized as a prime target for oncology as it has a dual mechanism in promoting the growth of tumors. Early clinical studies have shown that the company’s lead asset in cancer, TTI-101, is well tolerated and has clinical activity.
Tvardi Therapeutics, based in Houston, Texas, is actively recruiting for a highly motivated Head of CMC. CMC is primarily outsourced to contract manufacturing organizations (CMOs) and contract research organizations (CROs). This role is to provide day-to-day management of these activities. The candidate must have substantial experience (>7 years) in managing US and International CRO/CMOs for the manufacture of cGMP active pharmaceutical ingredients (APIs) and drug product (DP) with a preference in experience with small molecules.
Vendor Management: Interact with CMOs and CROs to complete pre-clinical, IND-enabling and clinical activities. Manage vendor contracting including MSAs, work orders, and invoices. Prepare RFPs and detailed itemized proposal comparison. Ensure vendors stay on-task and complete contracted work in timely manner through weekly conference calls. Confirm vendors adhere to communication plan with necessary members of the Tvardi team. Integrate deliverables and dependencies between vendors seamlessly. Conduct and coordinate review of technical documents and reports from manufacturing, toxicology, and other activities.
Regulatory Affairs: Working knowledge of FDA and EMA regulations and requirements. Compile, review and author IND modules for drug substance, drug product, pharmacology and introductory material. Ensure third-party reports are within protocol regulations and formatted correctly. Interact with eCTD vendor to manage submission of IND packages, briefing documents and other material to the FDA.
Risk Mitigation: Generate weekly status reports for all on-going activities. Prevent slippage from aggressive development timelines. Develop contingency plans to quickly and efficiently adapt to challenges that may arise. Create forward-looking Gantt charts and project plans to guarantee timely initiation and completion of activities. Provide strategies to reduce technical and logistical risks. Identify root causes of issues to prevent in future projects.
Teamwork: Work independently and collaboratively in a matrixed environment. Be able to successfully work with other Tvardi team members in projects spanning multiple stages of development. Interact with Tvardi leadership, laboratory and development staff, consultants and vendor personnel to successfully communicate expectations and responsibilities and to promote awareness of ongoing activities and upcoming deliverables. Record keeping: Keep detailed records of all activities, data, and reports in central repository. Maintain organization of central repository. Ensure necessary personnel have access required documents.
- 7+ years of industry experience in small molecule therapeutics or drug development
- Demonstrated relevant experience in CMC activities and projects
- Involvement in interactions with FDA or other regulatory bodies
- Passion for teamwork, immense energy, absolute integrity, and an A+ attitude
- Organized with ability to multi-task
- Critical thinking, decision-making, and problem solving
- Budgeting, from both a time and cost perspective
- Knowledge of toxicology, preclinical development, medicinal chemistry practices, regulatory guidelines and stages of drug development
- Experience in IND submissions to the FDA
- General knowledge of cancer and/or chronic inflammation/fibrosis
- Experience in contract management
- Attention to detail
- Capacity to foster a fast-paced, yet supportive, working environment
- Strong written and verbal communication skills