Medical Director – Medical Advisor

📋 Description

• Oversees medical aspects of designated clinical studies in the role of a medical monitor.

• Frequently acts as the primary medical liaison for clients regarding assigned clinical studies.

• Provides medical guidance and oversight to support the Drug Safety and Pharmacovigilance department.

• Responsible for designing and developing protocols, as needed.

• Creates and presents project-specific and therapeutic training for project team members and clinical site personnel; offers training to client staff when necessary.

• Contributes medical and therapeutic expertise to Study Start Up, Feasibility, and Subject Identification processes.

• Inputs medical insights into data collection instruments, monitoring strategies, and review and analysis frameworks.

• Supervises assigned Medical Scientist team members and collaborates with Medical Director colleagues to evaluate clinical data.

• Reports identified trends and challenges, along with mitigation strategies, to clients and project teams to reduce risks to subject safety or the integrity of study data.

• Provides after-hours medical support for clinical studies.

• Complies with all enterprise policies, work instructions, standard operating procedures, and project plans.

⛳️ Requirements

• Oversees medical aspects of designated clinical studies in the role of a medical monitor.

• Frequently acts as the primary medical liaison for clients regarding assigned clinical studies.

• Provides medical guidance and oversight to support the Drug Safety and Pharmacovigilance department.

• Responsible for designing and developing protocols, as needed.

• Offers input on protocol amendments.

• Creates and presents project-specific and therapeutic training for project team members and clinical site personnel; provides training to client staff when necessary.

• Contributes medical and therapeutic expertise to Study Start Up, Feasibility, and Subject Identification processes.

• Inputs medical insights into data collection instruments, monitoring strategies, and review and analysis frameworks.

• Supervises assigned Medical Scientist team members and collaborates with Medical Director colleagues to evaluate clinical data.

• Reports identified trends and challenges, along with mitigation strategies, to clients and project teams to reduce risks to subject safety or the integrity of study data.

• Provides after-hours medical support for clinical studies.

• Complies with all enterprise policies, work instructions, standard operating procedures, and project plans.

• Maintains comprehensive knowledge of FDA and global drug development regulations as well as national and ICH Good Clinical Practice (GCP) guidelines.

• May assist with responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), as needed.

• May represent the company at scientific conferences, as requested.

🏝️ Benefits

• We are dedicated to the professional growth of our employees through career development and advancement;

• supportive and engaged line management;

• technical and therapeutic area training;

• peer recognition and total rewards program.

• We are committed to fostering an inclusive culture – where you can genuinely be yourself.

• Driven to Deliver – reflecting our colleagues' enthusiasm to contribute each day and create solutions that can significantly impact someone's life.

• We are continually working on building the company that we all aspire to work for and that our clients wish to collaborate with.