Actual job title will be based on education and experience.

This position reports to the Chief Medical Officer.

Essential Duties and Responsibilities:

• Manage and oversee the Clinical Operations execution of First-in-Human studies and associated activities in compliance with GCP and regulatory requirements.
• Supervise site selection process, identifying and evaluating potential sites
• Participate and/or lead in the development of Clinical Operations Standard Operating Procedures (SOP) and training materials.
• Manage study activities to ensure compliance with protocols, ICH/GCP, and global regulatory guidelines. Ensure legal, ethical, efficient, and professional conduct of studies.
• Manage and oversee project delivery, including monitoring progress, agreed-upon timelines and deliverables, project finances, and expenditures.
• Manage budget negotiations with sites and vendors, track expenses, ensure accuracy of invoices submitted for payment, and ensure alignment of resources and budget across programs through evaluation of timelines and task prioritization.
• Supervise vendor selection process, manage vendors, including clinical and analytical Contract Research Organizations (CROs).
• Lead the operational development of study documents and tools, including but not limited to protocols, consent forms, project plans, budgets, and other necessary documents such as Data Monitoring Plan, Safety Monitoring Plan, Medical Data Review Plan, Safety Monitoring Committee Charter, Investigator’s Brochure, and Development Safety Update Report.
• Implement and oversee Trial Master File and other requirements for inspection readiness, such as quality and financial audit certificates.
• Organize and lead operational aspects of training sessions for clinical study teams on protocol-specific topics.
• Provide study updates, including identifying risks and issues, while working with necessary teams towards a resolution.
• Recommend and implement innovative processes to improve clinical trial management and deliverables, including contingency plans.
• Oversee operational aspects of ongoing data reviews and data cleaning activities.
• Provide oversight of activities related to site identification, qualification, selection, initiation, monitoring, and close-out activities.
• Support audits of sites and vendors.

Education and Experience:

• Bachelor’s degree (or equivalent) in a relevant scientific field preferred.
• Minimum of 7 years of clinical trial experience, including clinical trial management and clinical monitoring in pharmaceutical, biotech, academic medical center or CRO setting; oncology and/or immunology study experience preferred.
• ICH/GCP Training
• 5+ years of experience in clinical program management.
• Experience managing Phase 1-2 trials, knowledge of clinical operations, ICH/GCP, and regulatory requirements; experience with First-in-Human studies preferred.
• Thorough knowledge of drug development, clinical operation processes, and procedures according to ICH/GCP and other regulatory guidelines.
• Proven ability to manage multiple projects simultaneously in a changing environment.
• Strong organizational and time management skills.
• Excellent communication skills, both oral and written.
• Strong team player with demonstrated success in a cross-functional team and fast-moving environment.
• Proven ability to collaborate effectively with internal teams and external collaborators.
• Self-motivated, comfortable working in a start-up environment where everyone contributes to achieving company goals, flexible, and innovative.
• Expertise with an Electronic Data Capture System such as Medidata Rave
• Strong Microsoft Office skills are required: specifically, Outlook, Word, Excel, and PowerPoint
• Ability to travel at least monthly to the US Corporate Headquarters in Washington, DC, and/or to sites

Excellent benefits with 4 weeks of Paid Time Off plus additional leave. Schedule flexibility. Eligible for family health, dental, and vision coverage on date of hire. 401k Plan with 3% Safe Harbor Match.

Biolojic Design provided the wage range above in accordance with State Transparency Laws to support Equal Pay initiatives. This pay range is subject to change at any time, and pay will be commensurate with experience and/or other factors allowable by law.

About Biolojic Design: Biolojic Design is at the forefront of revolutionizing drug development through the application of machine learning. Our innovative approach involves programming antibodies as dynamic functional switches using AI, resulting in drugs that offer superior efficacy, lower toxicity, and impeccable safety. Our AI-designed antibodies are tailored for precise molecular effects within specific microenvironments, demonstrating a commitment to pushing the boundaries of biotechnology .

Biolojic Design is an equal opportunity employer committed to giving all qualified applicants consideration for employment without regard to race, color, religion, sexual orientation, gender identity, military/veteran status, or national origin.

Applicants must be currently authorized to work in the United States on a full-time basis.

More about us: https://www.biolojic.com/