This is a Senior Medical Director - Psychiatrist in Jackson, Mississippi

Summary: Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Duties & Responsibilities: Provides medical oversight of assigned clinical studies in the duty as a medical monitor. Often serves as primary medical contact for customers for assigned clinical studies. Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department. Responsible for protocol design and development, upon request. Provides input into protocol amendments. Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed. Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts. This activity includes, but is not limited to, review of Informed Consent Templates and Subject-Facing Materials, and input into site feasibility evaluations. Provides medical input into data collection tools, monitoring plans, and review and analysis plans. Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data. Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data. Provides after-hours coverage for clinical studies. Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans. Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines. Leads medical responses to Requests for Proposals (RFPs) and Bid Defense Meetings (BDMs). May support Requests for Information (RFIs). Contributes to the development of product/clinical development plans and collaborates with customer and internal colleagues regarding other reports, applications, and regulatory submissions. Locates and engages external experts/consultants/advisors as necessary. Represents the Company at scientific and industry meetings. May publish scientific or industry-related articles in industry journals, as requested. Mentors staff to ensure an appropriate level of understanding regarding sound treatment and research principles of specific therapeutic area. Ensures project teams consistently operate in compliance with such principles. Assumes line management duties as needed.

Requirements and Qualifications: Will Be Provided By Employer

Equal Opportunity/Affirmative Action Employer.  

Job #625844