Medical Director – Nephrology, Internal Medicine

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Lead medical initiatives for clinical study teams.

• Develop clinical trial protocols based on the most current scientific research.

• Participate in site selection and review, as well as approve study protocols, amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions, and other clinical documents.

• Perform real-time medical monitoring of clinical trials.

• Ensure the medical integrity of primary endpoints and the safety of participants.

• Detect medical issues early and proactively address customer concerns and corrections alongside the Global Medical Indication Lead.

• Advise internal teams and assist staff with procedural and budgetary matters and protocol revisions.

• Coordinate activities to effectively resolve issues and close gaps in a timely manner.

• Act as the primary liaison between the sponsor and PPD's internal departments throughout all phases of the study.

• Provide education to investigator sites through presentations and demonstrations of protocol-specific laboratory procedures.

• Oversee daily operations of clinical trials, troubleshoot issues, and respond to inquiries.

• Serve as the medical point of contact for both internal and external stakeholders.

• Engage with investigators and respond to inquiries from Institutional Review Boards (IRBs) and Health Authorities.

• Prepare and deliver materials to study executives and independent safety committees when necessary.

• Offer medical training to site staff and training for Clinical Research Associates (CRAs) in new indications.

• Ensure adherence to relevant Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP).

• Collaborate with cross-functional study team members to clarify medical risks, issues, and outcomes.

⛳️ Requirements

• Medical Doctor with a specialization in Nephrology or Internal Medicine.

• Clinical experience in treating nephrology patients within hospital settings.

• Experience in clinical development within the industry.

• Extensive background in the pharmaceutical industry, clinical trials, and pharmaceutical medicine.

• Proficient in both spoken and written English.

• Knowledge and experience with the New Drug Application (NDA) submission process.

• Familiarity with regulatory guidelines concerning adverse event reporting.

• Excellent communication and presentation skills.

• Strong ability to work collaboratively in a team environment.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Equal employment opportunity and affirmative action environment.

• A diverse and inclusive workplace that values various experiences, backgrounds, and perspectives.