Sr Clinical Trial Lead - Immunoscience
About the Job
This position is based in Lawrenceville, New Jersey.
• The successful candidate will provide expert clinical input to the therapeutic area from discovery through early clinical development, registration and lifecycle management.
• He/she is a knowledgeable medical monitor who will partner with development colleagues from CROs to design and implement strategically aligned, efficient clinical trials that meet ethical, scientific, safety, regulatory, and commercial objectives.
• He/she will review and interpret clinical data, and guide appropriate recommendations and decisions on drug candidates under investigation.
• He/she will contribute to strategic discussions on asset advancement and decision-making as data accrue.
• Other responsibilities include contributions to the writing and review of responses and reports submitted to regulatory agencies, identifying and building relationships with thought leaders and investigators, and gathering input on disease areas and design of clinical programs.
• Qualified individuals must possess an MD (or equivalent) or MD/PhD degree. Therapeutic background flexible, but rheumatology, gastroenterology, CV, inflammation/immunology and/or autoimmune disease background are preferred
• Experience in designing and executing clinical trials
• Expertise in implementing scientific methods to test hypotheses, design, analyze, interpret and report results
• Understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements
• Experience with heath authorities and regulatory submissions
• Comfortable working in a fast-paced environment where speed is paramount
• Willing to work outside of a traditional functional environment, in a team unified around serving the assets
• Ability to recognize, articulate, and accept calculated risks to make informed decisions
• Willingness and ability to form strong, productive partnerships with external providers
• The candidate should have excellent communication skills and experience delivering effective presentations on both technical and nontechnical subjects.
- Minimum 5 yrs of experience as a medical monitor with proven track record designing and overseeing clinical trials, ideally both early and late stage
- Experience supervising CRO-driven studies
- Experience with health authorities and regulatory submissions
- Understanding of the clinical development process, and the role of non-R&D functions\:
- Commercial, health outcomes, access, medical
- Proven ability to partner effectively with key internal and external stakeholders