Principal Medical Scientist

Job Responsibilities:

• Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met.
• Serves as primary interface between internal team, customers, and vendors in the areas of medical monitoring, medical data review, eligibility review and other project specific medical services.
• Works with Medical Directors to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan).
• Works with customers to develop non-standard procedures and project plans.
• Performs regular and ad-hoc medical review of data listings and visualizations as needed; analyses the data to identify risks and data patterns/trends and supports documentation of medical reviews.
• Pro-actively identifies and resolves medical data review issues as they arise.
• Provides advanced medical data review on various project level data as needed.
• Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management to identify risks related to data integrity and subject safety.
• Identifies and escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of scope tasks to the project leads in a timely manner.
• Troubleshoots situations as needed.
• Acts as key scientific leader on customer partnership/portfolio/coalition level.
• Attends strategic meetings with customers.
• Leads Scientific Services team on a project and evaluates resourcing needs.
• Serves as respective area’s Subject Matter Expert (SME) to ensure that project teams consistently operate in compliance with research principles and procedures.
• Provides scientific oversight and project/product development training to company staff and project teams.
• Attends and presents at Trusted Process meetings and may participate in internal and external audits or inspections.
• Assists with responding to findings from audits or inspections.
• Contributes to general and project-specific training.
• Assists Medical Director(s) on the review and development of training material and project-level documents, including but not limited to clinical protocols, clinical study reports, abstracts and manuscripts, presentations, investigator brochures, and various other internal and external documents and communications as needed.
• Develops, or oversees the development of, work orders and change orders for projects involving MSM.
• Contributes to company business development activities by providing scientific input into data collection tools, data monitoring plans, requests for proposals (RFPs), as assigned.
• Acquires understanding and knowledge of ongoing protocol designs and disease related terminology and pathology.
• Provides strategic oversight and active contributions to the planning and development of medical monitoring and scientific services activities, as well as provides direction and oversight across all research projects, and other research-related activities.
• Evaluates processes for improvement in efficiency and effectiveness and recommends changes; participates in process development and improvement of departmental functions.
• Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans.
• Adheres to customer policies and standard operating procedures, as required in project plans.

Summary:

Demonstrates process expertise and therapeutic area knowledge. Acts as a key scientific leader on projects. Collaborates with Medical and Scientific Management (MSM) team members as well as with functions outside to provide high-quality deliverables. Responsible for coordinating the functional team members and their activities for medical and scientific services, liaising with project leadership and the customer to ensure that the MSM deliverables (timelines, quality, productivity) are met. This role has overall accountability for the execution of the Medical Management strategy on the project.

Equal Employment Opportunity:

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. The Company also conforms to the EU Equality Directive in all countries of operation, ensuring equal opportunity in recruitment and employment.