Job scope/Job Mission

The candidate should have solid training and/or broad experience in rare disease clinical development. The candidate will work with clinical project teams to support medical aspects of the clinical programs, including medical monitoring, communication with principal investigators (PIs) on clinical trial sites, optimizing study designs, helping with data readout, reporting clinical trial data and presenting updates to the senior management. This candidate will also be a resource to teams on all matters related to analysis and communication of clinical data. In addition, the candidate is expected to be skillful in integrating information from various functions and be articulate in communicating company clinical development strategy to internal and external stakeholders.

The candidate must be a team player and is expected to work with other scientific and clinical staff in executing the clinical programs. 

The position can be full-time, remote with ideal candidate in proximity to a major airport.

Main Responsibilities

Core Job Responsibilities

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.Review and manage clinical development budgets and provide forecasts to the clinical development and finance team members

Requirements (Education, Work Experience, Any specialty?  # Years experience, Soft skills/Leadership)

Medical Degree (MD or DO).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.Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.Willingness/ability for domestic and international travel with proximity to a major airport.