Job Summary

Drive Innovation in Rare Disease Clinical Development
We are seeking a clinical development professional with strong training and/or broad experience in rare diseases. In this role, you will collaborate closely with clinical project teams to support the medical aspects of our programs, including medical monitoring, communication with principal investigators, optimizing study designs, contributing to data readouts, reporting clinical trial results, and presenting program updates to senior leadership. You will serve as a key resource for analyzing and communicating clinical data and will integrate insights across functional areas to clearly articulate the company’s clinical development strategy to both internal and external stakeholders. Success in this role requires a highly collaborative team player committed to working seamlessly with scientific and clinical colleagues to advance our clinical programs.

What you'll do

• Serve as a Study Medical Monitor, authoring clinical trial documents including protocols, investigator brochures, ICFs, training materials, and DSURs.
• Provide clinical development support and scientific opinion to study teams.
• Contribute to the development and optimization of clinical trial study designs.
• Work closely with Clinical Operations to execute clinical trials with high quality, deliver results and meet target timelines.
• Drive contribution of clinical content for deliverables in support 
• of regulatory submission activities and ensure flow and accuracy of key data for clinical module sections of the IND.
• Provide medical input for the clinical database build, CRFs, monitoring plan, data management plan, safety monitoring plan and statistical analysis plans.
• Contribute to the ongoing scientific review of clinical trial data and assist with query generation/resolution and data analysis. Work closely with PV, Data Management, and other vendors to ensure appropriate review and documentation of clinical trial data.
• Maintain scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Stay abreast of internal and external developments, trends, and other dynamics relevant to the work to maintain a fully current view.
• Develop and maintain relationships with a variety of internal and external partners and stakeholders, including clinical investigators, study coordinators/CRAs and KOLs.

Qualifications and need-to-know

• Advanced degree required: MD, DO, PharmD, PhD, or an equivalent advanced degree in a medical, biomedical, or related scientific field
• 5+ years’ experience in clinical development with at least 2 years in the biopharmaceutical industry. Experience in translational medicine/early phase oncology clinical trials is a plus.
• Understanding of GCP/ICH/IRB and local regulatory authority drug research and development guidelines and regulations.
• Proven ability to interact and work with external partners (PIs and consultants) with regards to clinical development functions.
• An understanding of the clinical trial processes, such as study start up, patient recruitment and safety, non-compliance, management, and monitoring of investigative sites.
• Excellent problem-solving skills, a strong sense of urgency and keen attention to detail. Well organized with the ability to effectively manage multiple priorities in a dynamic, cross-functional teamwork environment under time and resource pressures.