The Position: Landos Biopharma Inc. is looking for a highly motivated Project Manager (PM) with previous industry experience drug development or the pharmaceutical industry. The ideal candidate will be and a well-organized, detail-oriented individual capable of synergizing with existing team members and promoting the Landos culture in external relationships with vendors in order to navigate the development of small molecule therapeutics.
The candidate will be aligned with four fundamental pillars of Landos’ corporate culture: 1) Be bold and decisive, 2) Never give up, 3) Be solution-oriented, and 4) Do the impossible.
Vendor Management: Interact with contract manufacturing organizations (CMOs) and contract research organizations (CROs) to complete pre-clinical, IND-enabling and Phase I 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 Landos 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 Landos team members in projects spanning multiple stages of development. Interact with Landos 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 as directed by the Landos leadership team. Maintain organization of central repository. Ensure necessary personnel have access required documents. Any new responsibilities or changes in the reporting structure as directed by the Landos leadership.
- 2+ years of industry experience in small molecule therapeutics or drug development
- Demonstrated relevant experience in CMC and GLP toxicity activities and projects
- Involvement in interactions with FDA or other regulatory bodies
- Passion for teamwork, immense energy, absolute integrity, and an A+ attitude. Important skills:
- 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 chronic inflammation and autoimmune disorders
- Experience in contract management
- Attention to detail
- Robust initiative, passion for Landos Biopharma Inc.
- Capacity to foster a fast-paced, yet supportive, working environment
- Strong written and verbal communication skills
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off
- Flexible schedule
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